Hi!

We’re a patient owned pharmaceutical company with a drug that reverses peripheral neuropathy. Peripheral neuropathy is a is a neurodegenerative disease that affects nearly 1 in 15 people.

Peripheral neuropathy is a slow often unspoken, and definitely neglected, complication that arises from many other diseases: over half of all diabetics, nearly half of all cancer patients, a third of all HIV patients, and many from unknown causes.  But many of you probably know all this. 

Unfortunately, as many of you know, there are no treatments other than pain killers. Our drugs now appear to be reversing this disease, starting with the underlying biology, nerve regrowth, and then return of function and, most importantly, quality of life.  We hope we are a new model for pharma – patient-centric.  Not just in developing a drug that works, but safe, and transparently affordable.  In fact, we are now patient owned.  So, impact to patients – that is our goal.

We are Stanely Kim and Katie Frizzi—the CEO and Project Scientist for Winsantor. Ask us anything!

And check out some cool pictures on Twitter ! https://twitter.com/WinSanTor

https://twitter.com/WinSanTor/status/1125425401533124608

Hey everyone! Thanks for all the questions. We are going to head out now but if you have anymore pressing questions or you'd like more information about our drug or our company please email us at: [[email protected]](mailto:[email protected])

Many of you are asking about our clinical studies. We will have several small studies in Canada, Europe and US for diabetic peripheral neuropathy in 2019. It will expand to other indications, financing/resource dependent. Find out more by signing up for our newsletter (biannually) at our website. Also help us by signing up for our survey (anonymous) to give us a sense of you and your condition

Comments: 165 • Responses: 64  • Date: 

Pebbledash228 karma

Can’t express how much I appreciate the work you’re doing—gives hope to an under-served community.

I’ve never used AMA, so apologies if I’m not following protocol with the bucket-load of questions!

  1. Any indications that the treatment might work for those with Idiopathic forms?
  2. As nerves heal (regenerate) is there an increase in sensations, such as a temporary rise in pain?
  3. Is there a point when nerve damage is too far gone to improve? Does duration of condition affect healing—have you studied subjects with, say, a decade or more of neuropathy? When is "too long?"
  4. Any recommendations for supplements while awaiting approved treatments?
  5. Do you have compelling evidence that your animal studies will translate to humans?

WinSanTor8 karma

Katie:

Wow, lots of questions...I'll do my best.

  1. Yes, our drug targets and seems to regenerate nerves themselves, it does not cure the cause of the neuropathy. Because of this we are hopeful that it can treat idiopathic neuropathy as well.
  2. That was a concern of ours (really mine) but so far we haven't seen any evidence of this
  3. Yes. Dead nerves are dead and we can't bring them back to life. But we believe that our drug can support the remaining nerves and cause collateral sprouting to 'fill in' the space left by the dead nerves. But that assumes that there are enough remaining nerves to do so. I can't really say when would be too long, since some neuropathies occur rapidly and others are slower.
  4. Exercise is pretty great for nerve health.
  5. Our early testing in humans is very promising. I can't say too much on this until our next paper is published, but I'm hopeful.

WinSanTor5 karma

Stan: I've never used AMA either so we are even.

1) Idiopathic is tough for clinical studies or for approval. It is PN with an unknown cause. And with so many different symptoms, it will be hard for us to run trials for idiopathic peripheral neuropathy.

There is hope. Again, we are trying to do everything we can for patients. So, with the new "Right to Try" provisions of the US laws, we may be able to help some patients earlier. One thing patients can do is fill in the survey as we still are learning about peripheral neuropathy generally. I learn so much from patients, including their symptoms. As we see what symptoms are being resolved, we may learn better how nerve regrowth affects these different symptoms.

2) Interestingly, we do see increase in sensation so increase in pain could be an affect we may see in some patients, temporary or otherwise. The data of the scientists have not been published and some of this, we are also validating in the phase 2 studies. But things look promising.

3) I think Katie answered this question.

4) Unfortunately, I cannot tell you what to take, supplements or otherwise.

5) Many animal studies do not translate well. So far (knock on wood), we do see strong correlations between what we saw in the animals and in humans.

jeauxv7 karma

When do you expect this drug to be available to patients? My father is currently on pain killers and is hoping for a cure

WinSanTor7 karma

We are very patient centric - so we are doing everything we can to get an impactful drug to patients ASAP. We are impatient as well. For some patients, they can apply for one of the several trials we'll have ongoing this year. It will start with diabetic peripheral neuropathy. Later, hopefully we will have trials for chemo-induced peripheral neuropathy. We are looking to expand into other forms of neuropathy soon.

A lot of our activity will depend on our resources. We are a small company reliant on, for the most part, government grants. This is a field that is neglected from pharmaceutical companies, and thus investors. I've been told that, even with data that shows reversing the disease (some may call it a "cure" for certain types of PN), that there is no market. That is what we fight.

We also want to learn more about our patients, so please to go our website (www.winsantor.com). We have a survey. I'm learning so much from our patients, so please give us feedback. We hope that we will one day be able to convince this industry (yes, my industry) that wanting to develop cures is the only thing we as an industry should focus on (money will follow).

Thump6047 karma

Can be get involved in clinical trials. The drug is approved for other conditions correct?

WinSanTor7 karma

Stan: Sorry if I'm taking two steps backwards to move forward. Clinical trials is Phase 1 (safety), Phase 2 (activity and safety) and Phase 3 (safety and efficacy). Typically, this is first in the US and then after approval, into other countries (Yes, long process).

WST is now in Phase 2 for diabetic peripheral neuropathy, starting in Canada, then in Europe and finally US. This is all planned for this year. We will start trials in the US later this year, hopefully.

Yes, WST-057 was approved in other countries in a pill for stomach ulcers, never approved here. Either way, although faster, still has to go through clinical studies.

mmm_toasty6 karma

Do we know what biological mechanism causes neuropathy, generally speaking, or are there many etiologies across the spectrum of patients suffering from it?

WinSanTor5 karma

There are multiple causes of peripheral neuropathy, the good thing about our drug it that is seems to fix many peripheral neuropathies, regardless of the root cause. (Katie)

mmm_toasty2 karma

What are some of those causes? Are there any that your drug works especially well or poorly in targeting?

WinSanTor1 karma

Katie: Some causes of peripheral neuropathy: aging, diabetes, HIV infection, cancer treatments, surgery... There are a lot.

We've started our testing in diabetic patients since peripheral neuropathy very widespread in this population. We are actively attempting to expand our testing to other etiologies as well.

fermata1025 karma

Does your compounding recipe have excipients that help skin penetration? How can it have a local effect but not travel throughout the bloodstream? This is confusing me.

WinSanTor3 karma

Stan: You are asking very good questions (I notice your name pop up a lot), but many of these are still confidential. I have to be also careful here as some of the questions may also mislead some of the other readers, or are questions we are still exploring ourselves. I will try to answer some of these here (publicly) or privately, to clarify, or have to apologize in advance as I may not be able to answer them Thanks

Pebbledash24 karma

On behalf of JK: Even if you could regenerate the nerves wouldn't you also have to repair the micro-vascular system since that is what causes the damage?
Does their drug do this?

Thank You.

WinSanTor5 karma

Katie: Our drug provides a supportive environment for nerves and encourages their regrowth. It does not directly 'fix' any of the multiple causes of peripheral neuropathy. In the case of a damaged micro-vascular system causing the damage, our treatment would probably need to be ongoing.

gitrdone994 karma

Will this drug require a prescription?

Is it available now in any other country.

If this drug consists of approved substance why can't it be available now or why can't human trials be pushed up.

Can I become part of human trials or a volunteer.

WinSanTor3 karma

Stan: Yes, it will require a prescription.

No, WST-057 is not available in any other country. In full disclosure, people have found some of the original pills, but it appears that such high amounts would have to be taken orally that other complications arise (I would not recommend it).

Actually it will allow us to get our drugs faster to market. But, we have had a hard time accessing some of the original data (the original company has not wanted to release this information) so we are having to repeat some of these tests.

Maybe. The best I can do is forward you to one of the many sites we will be running later this year.

bcbcbcbc9991 karma

so, oral WST-057 may not be feasible? As you state that dosages required for effect may be too high resulting in complications? I understand that this is not a definitive statement and that clinical trials may prove otherwise.

Is Winsantor planning oral clinical trials?

WinSanTor1 karma

Yes, we are planning on developing drugs for oral use. But more than likely, this may mean developing a completely novel drug which will be even longer trials. Just FYI, most drugs take 10-15 years to develop.

SilentSkeeter4 karma

My son was born with Congenital Insensitivity to Pain. I don't know much about it other than he has a mutation of the SCN9A gene that causes his condition. Would your drug be able to help him have sensation at all?

WinSanTor2 karma

Katie: That is a super interesting question. I have no direct evidence either way, but I'm guessing that our drug would not be effective in this case since we would only be able to help him grow more of the same dysfunctional nerves he already has.

fcamacv4 karma

Where are you in terms of development? Have you proceeded to human trials? Results?

WinSanTor3 karma

Stan: Yes, we are in clinical studies -phase 2 to be specific for WST-057. But our group already has some evidence in humans that other drugs in the same class appear to be working to reverse (in humans) the biological (nerve growth) and functional (sensory and qualtiy of life) losses often seen with peripheral neuropathy. This gives us confidence we are on the right track.

One thing we chose with respect to WST-057 is that recycling this drug in a topical format - over 30 years of safety in a pill - gives us greater confidence in its safety. Phase 1 was all about safety - and our drug, not surprisingly did not show any adverse affects. Now to prove that our drugs work well in many more patients. Wish us luck.

NedTaggart3 karma

Can you give some more information about the nerve regrowth aspect of this? What aspect of the nerve is this repairing? What part of the neuron is this drug targeting so that is can be effective against diabetic neuropathy and HIV neuropathy, which have completely different etilologies?

WinSanTor3 karma

Katie: I'm not sure how to answer this question without giving out too much information about our drug's mechanism in a public place. Best I can do is tell you to google my name and check out some of my papers which really dive into the specifics.

Also check out our website, it has some good information on the science behind our drug: https://winsantor.com/peripheral-neuropathy-and-our-drug/

orangejulius3 karma

Have you done human trials and how receptive are patients to using your drug?

WinSanTor2 karma

Yes. Phase 1 is completed and now in Phase 2. So far so good.

remoteone993 karma

Can this reverse small fiber neuropathy? Is it something that must be used on an ongoing basis?

WinSanTor1 karma

Katie: Yes! small fiber neuropathy is our focus. Whether or not it will have to be used on an ongoing basis depends on the root cause of the peripheral neuropathy. For example, many chemotherapeutics like Paclitaxel for breast cancer cause peripheral neuropathy. If our drug is effective against preventing this neuropathy, the patient would not need ongoing treatments. Other more long term diseases like HIV may need ongoing treatment.

tamay03 karma

Having been diagnosed with small fiber neuropathy this year, I've been following your company and I appreciate your work since there are so few current treatment options. Are you testing to see if this treatment can be used indefinitely? I have ideopathic SNF, so I'm not sure I can ever treat what is causing my SNF and my nerves might deteriorate without a constant treatment.

WinSanTor2 karma

The trials are set up to see impact / effect. Can it be used indefinitely - we don't know. The safety studies in animals wil give us some guidance. So far, they look promising for longer term use. Not sure about "indefinitely".
I can say with some confidence that we are recycling a drug with significant safety history for this particular reason - safety. But we'll have to explore this question (indefinite use) after we get approval first.

WinSanTor2 karma

Katie: Since we are at the early stages of treatment we have not tested indefinite use yet. I see no reason why it could not be used indefinitely, but time will tell.

Pebbledash23 karma

For Lerch19 (from the other board):

I echo Pebbledash2's appreciation for what you're doing. Neuropathy patients are poorly served by the currently available treatments. Thanks in advance for considering these questions:

1 A re there human trial results available or due soon?

2 Is it possible to get involved in any future trials?

3 What would be a realistic time frame for the drug to be available for prescription?

4 Do you anticipate your drug being available for Idiopathic neuropathy as opposed to diabetic neuropathy?

Thanks!

WinSanTor3 karma

Katie: I think I can answer 1 and 2 by saying check out our website. https://winsantor.com

We keep it up to date with our results and how to register for our clinical trials.

3) this is a hard question because 1)the FDA is fickle and 2) we are planning on applying for use in multiple countries so it may get approval in some before others

4) Yes! Our drug works directly on nerve growth regardless of etiology

KaneHau3 karma

Hi... I have PHN in my left arm - left over from having a horrible shingles episode (prior to being of age to receive the vaccine, which I have since had).

Does your treatment work for PHN?

I was on Lyrica (top dose) while I had shingles, but it did little for the pain - and I couldn't work well due to the side effects of the drug (I'm a programmer and it made concentrating difficult). I weaned myself off it - but there is nothing that I've found to control the pain.

WinSanTor1 karma

Katie: I'm sorry you're going through that, peripheral neuropathy is a disease that can really affect a person's quality of life. I think that there definitely is a possibility for patients with PHN to benefit from our drug and I'm hoping we can expand our testing to a wide variety of peripheral neuropathic populations soon.

acatherder3 karma

Is there any possibility that these drugs could help treat spinal cord injuries?

WinSanTor2 karma

Gonna copy something I wrote earlier because it applies to spinal cord injuries too:

Katie: Right now the focus of our research is on small unmyelinated nerves. We don't currently have any data on if and how our drug affects myelination. If our company continues to grow and move forward it is definitely something we'd be interested in looking into.

WinSanTor1 karma

We don't know, but this unfortunately is a long way off for our studies and from our science. We are treating the nerve fibers (IENF) for now. I know this is unsatisfactory answer for many of you with spinal cord injury. But one thing at a time and the more proximal solution is in IENF recovery.

dancalica3 karma

Any thoughts about whether this will benefit those with Erythromelalgia? Also, any sense of when this may be available in the US or anywhere else in the world?

WinSanTor1 karma

Katie: Erthromelalgia isn't a model I've ever considered before. My interest is now piqued so I might start looking into it...

As for the timeline the best I can say is keep checking with our website. We keep it updated with our latest clinical trials and results. https://winsantor.com/join/

horse1392 karma

Good morning, Thank you so much for all the great work you are doing. Where do things stand in terms of treatment availability at this point?

WinSanTor2 karma

Stan: This is answered above, but to be more specific. FOR DIABETIC PERIPHERAL NEUROPATHY: We have three sites in Canada that will start recruiting in the next month. We have sites in Europe that will begin in a few months and, likely, we will have sites in the United States later this year. Please register with our website and we have a newsletter that will have more specifics.

For other types of peripheral neuropathy (PN), we will see. Hopefully, soon. Again, please register with our newsletter.

querquedule2 karma

Where are you located? I'm about to finish my undergrad and apply for grad school and I'm really interested in neuropharmacology!

WinSanTor2 karma

We are based in San Diego. But our scientists are in Winnipeg, San Diego and Toronto (you can now guess where the name of the company came from).

WinSanTor1 karma

We're based in Sunny San Diego.

thePopefromTV2 karma

[deleted]

WinSanTor1 karma

We will update people in our newsletter. Please register at our website at www.winsantor.com

WinSanTor1 karma

Please check out our website. We have a patient space where you can check and see if you are eligible for any of our trials: https://winsantor.com

MNC52 karma

Why are you going with topical form vs oral?

WinSanTor2 karma

Eventually, we will have other forms (separate from WST-057) that address different needs. Many people we are learning have peripheral neuropathy that affect them internally (nose, esophagus, etc). We will need to develop and are developing other drugs that address these other needs. But, first things first. Let's get WST-057 out.

WinSanTor1 karma

Katie: Like Stan said in another answer people have tried taking this drug orally for peripheral neuropathy, but the doses needed for it to be effective seem to be too high for the oral route. The side effects at those doses are limiting. By using the drug topically we can virtually eliminate all side effects and have minimal interactions with other medications our patients may be on.

MNC52 karma

Have you or do you plan to evaluate before and after skin punch biopsies to determine if epidermal nerve fiber density increases after treatment?

WinSanTor2 karma

Yes, the innervation of skin punch biopsies are our primary endpoint in our phase 2 trials. We are also measuring a lot of quality of life indices and functional tests.

enigmisto2 karma

What concentrations of pirenzepine are you exploring in your phase 2 and phase 3 clinical trials?

WinSanTor4 karma

Stan: I cannot tell you this information as it may be misleading or confidential, or harmful. I know many of our readers are anxious for our drugs, and some are trying to concoct it themselves. We are trying to find the best and quickest solution - and that unfortunately takes time. I hope you do not see my not answering your question directly as our way of being "corporate" and "greedy". We really are concerned when people could be or are hurt by being their own drug company. Thanks for understanding.

needmorexanax2 karma

Are you better than lyrica?

WinSanTor3 karma

Katie: For now, our targeted endpoints are nerve regrowth, not pain. Because of that, it doesn't make sense for us to design a direct comparison trial with Lyrica at this time. Since there is no current drug for nerve regrowth, we are testing our drugs' efficacy against a placebo.

oscar_the_couch2 karma

Will the drug be safe for children with peripheral neuropathy?

WinSanTor1 karma

Katie: We have not done any testing in a pediatric population so I can't directly answer this one. I can say that a very large study was once done by another research group using this drug as topical eye drops in children and they had very favorable outcomes.

MNC52 karma

Can your drug at all help autonomic nerve damage or autonomic neuropathy symptoms?

WinSanTor3 karma

Katie: We've just started investigating the effect our drug may have on autonomic nerve damage. Check out our twitter account, I uploaded some cool sweat gland images there showing how we measure autonomic function and our drug's effectiveness against it.

MNC52 karma

When you say "reversal" do you mean alleviating symptoms or actually reversing damage and healing nerves? Can it also stop progression of further damage?

WinSanTor5 karma

Stan: The studies in humans included biopsies as well as funtional tests. It showed signficant improvement of both. Again, this was by our scientists to understand whether our class of drugs would work. One of those drugs worked very well (tested on humans). We are taking what we believe to be the safest of those drugs (from the class of drugs tested on animals) forward.

igniz02 karma

Do you think this drug can also be used to treat Fibromyalgia? (Sorry if completely unrelated) thanks! And amazing work

WinSanTor2 karma

We don't know. One reason for our survey is so that we (WinSanTor) can have a better understanding of YOUR disease. For example, everyone talks about numbness, tingling and pain. I did not know that there was significant cramping and fasciculation in may patients. There are many other symptoms I'm just learning about. So, I don't know the anwer to your question. At least not yet.

Thump6042 karma

Is the treatment potentially an aid for ulnar neuropathy?

WinSanTor3 karma

Right now most of our research has been focused on small fiber nerve in the skin but we have had some hints of effectiveness on larger fiber nerves as well. We are investigating this possibility thoroughly. (Katie)

cahaseler2 karma

Do you think patient owned pharmaceutical companies are a workable solution to rising Healthcare costs?

WinSanTor5 karma

Stan: Honestly, I don't know. It seemed like a good idea to me and our team. We figured if we were doing this for patients, why not allow them to benefit in more ways than an eventual drug. Plus, we know we will have them on our minds the whole time (some of my shareholders are very ... "opinionated" - LOL - they are all good).

I'm not from the pharmaceutical world. If you read my bio, you'll see that I come from the world of innovation (mostly technology and biology). I saw something in the pharmaceutical world I didn't like (not everyone, but enough) where I figured we weren't going to play that game. We are trying to develop what we percieve to be a sustainable healthy company.

Sorry if I didn't answer your question. I'm not that smart - LOL.

MNC52 karma

Can this help treat non length dependent small fiber neuropathy? I.e. symptoms are not just in hands or feet, but may be wide spread.

WinSanTor3 karma

Katie: It is our hope that our drug will be effective against widespread neuropathy. One of the areas I've been focusing on is the innervation of the cornea. It turns out that corneal nerves are often good indicators of full body nerve health. Corneal nerves are great to study because they are easy to image without invasive and time consuming biopsies and stains that traditional neuropathy tests rely on. Check out our twitter for pictures of corneal nerves. https://twitter.com/WinSanTor

chooter2 karma

What are some things you wish more people knew about regarding peripheral neuropathy?

WinSanTor3 karma

Stan: Tough question:

For us, I think I mentioned before that there are many in my industry that think 1) PN is not a problem, 2) can be solved by pain drugs, 3) there is no market for reversing the disease, 4) there is no money in developing a treatment for it, 5) recycling a drug is not profitable and ... 6) should only be addressed if we charge a lot of money for such a treatment. and 7) many people suffer from it silently (and unnecessarily).

For patients (I'm told), I think they wish more people knew about the disease and the suffering.

Our strategy in the company had to change because of many of these things. We had to take three steps backward (education, advocation, ...) to move forward. Our goal is that by the end of this AMA, we stir up a conversation and that we can push all of you to help us move forward collectively. Tell people about what we are doing and get them excited about developing a treatment for this neglected disease. We want to create an army of people all going toward the same goal

And I'm going to have one plug. We do need additional resources. We will need more people aware (doctor and patients) volunteers, advocators, investors, etc. So if any of you know anyone, please send them our way.

WinSanTor3 karma

Katie: I'd like people to realize how incredible widespread it is. We have been told directly by investors that there is no market for our drug when we know for a fact that millions of people are affected by peripheral neuropathy.

SSJGodFloridaMan2 karma

Does Winsantor, either through individual high-ranking members or through Political Action Committees donate to any political candidates?

Will you share which ones and how much, if so?

WinSanTor4 karma

Katie and Stan: We barely have enough money to keep the office stocked with coffee. We don't donate to any politicians or political action committees.

goletasb2 karma

Have you run into any unexpected side effects in the course of developing the drug? Are there other uses outside of reversing peripheral neuropathy?

WinSanTor2 karma

Katie: Our drug has a remarkable safety profile. It was used for over 30 years in pill form for stomach ulcers in other countries, just never in the US. All of our phase I testing proved that is also very safe as a topical cream. Now we are on to proving it's also effective.

WinSanTor1 karma

Stan: It was also used in children (ages 8-12) for about a year in an eye drop, where it was shown safe.

Drapester2 karma

How does your company's approach deal with the need to re-mylienate neurons for functional conductivity? My daughter is blind due to a congenital issue and I'm curious if something like this could eventually help people like her, who need nerve growth and function restoration.

WinSanTor1 karma

Katie: Right now the focus of our research is on small unmyelinated nerves. We don't currently have any data on if and how our drug affects myelination. If our company continues to grow and move forward it is definitely something we'd be interested in looking into.

kingshmiley2 karma

What can the average person do to identify signs of potential Peripheral Neutopathy in themselves and those around them? What should we do if we see signs?

WinSanTor5 karma

There isn't really much you or anyone can currently do to treat early peripheral neuropathy. It's usually not even diagnosed until it starts having a major impact on a person's life. The best prevention advice I can give is don't get diabetes, cancer, HIV, or really age at all. (Katie)

WinSanTor2 karma

Stan: There are ways to mitigate certain forms of neuropathy - for example by mitigating early diabetes (food and exercise and good health). Also, the cause for some people of PN include certain drugs, which may have been caught earlier if known. Some doctors unfortunately do not know what PN is or what causes it. Like mentioned above, we are making a big push to get more people aware, including doctors....

MNC51 karma

Why is the existing formula of this drug not available for rx in the US for PN or SFN?

WinSanTor1 karma

The active ingredient was never approved here in the US for any disease. It was approved in other countries but quickly abandoned for marketing purposes over 30 years ago. We have to develop here for approval de novo because it is a "new drug" - with 30 plus years of safety information.

barsmart1 karma

/u/WinSanTor - I think this question is more akin to one of mine... WHY wasn't it approved for use in the USA? Did it fail FDA?

WinSanTor1 karma

Katie: No, our drug has never been presented to the FDA for approval. It wasn't approved in the US because in the US it was quickly discovered that proton pump inhibitors were more effective and easier to market against stomach ulcers.

nickname_esco1 karma

What are some of the causes of peripheral neuropathy?

WinSanTor1 karma

The major causes are diabetes, different drugs such as chemo or certain antibiotics, infectious diseases. You can see a list of different causes by reading this thread.

insanitorian1 karma

at what average age can someone get this disease? Stupid question, i know

WinSanTor1 karma

Depends on the type of neuropathy. That said, it does mostly affect diabetics who've had the disease for some time (as far as total number of people affected). I have received emails from individuals as young as teenagers who have neuropathy caused by different drugs and hereditary diseases.

darth_hotdog1 karma

Any idea if this could lead to treatments for hearing loss or tinnitus?

WinSanTor1 karma

I know that there are variations of hearing loss. The answer is I don't know.

ThePharmachinist1 karma

Any potential for WST-057 to be used for peripheral neuropathies like CRPS/RSD (Chronic Regional Pain Syndrome/Reflex Sympathetic Dystrophy) or from neuropathy due to trauma like surgery or following severe cases of various anemias?

WinSanTor1 karma

Possibly. CRPS is so ambigious that it will be difficult for us to say our drugs work for the disease or condition. Same with the other conditions you mention. It will likely be that for these conditions, our drugs will be approved and then based on case-by-case treated by each doctor.

pwrwisdomcourage1 karma

Are there plans to use this in MS patients?

WinSanTor1 karma

MS is a differnt type of neuropathy - different type of nerve damage. With MS, you see a lot of neuromuscular degradation. So far, our primary focus is sensory nerves.

dramofeale1 karma

Very exciting concept! Is your Phase II registered with ClinicalTrials.gov?

WinSanTor1 karma

Not yet. It will be soon.

Plastic_sporkz1 karma

/r/winsantor is it possible to sign up for clinical trials? I have diabetic neuropathy in my feet and am in pain all the time, which is definitely impending my life. I have the diabetes under control but so far nothing has helped with the pain and numbness In my feet. I would love to be apart of the trial for this in the US.

WinSanTor1 karma

Please sign up for our newsletter at www.winsantor.com and we should have an update with more specifics in the next few weeks. Also, if you can sign up for our survey, that would help us out a lot.

NorthernHackberry1 karma

Would this medication potentially be useful for nerve damage from physical trauma?

WinSanTor1 karma

Possibly. Again, physical trauma causes lots of damage to many tissue and organs, with many different symptoms. Please go to our website and fill out our survey so that we can have a better understanding of your condition.

stygarfield1 karma

Has there been any pushback or grief from the other pharmas?

WinSanTor3 karma

I'm not the most welcome person at many of the conferences. I've had potential investors walk out mid-sentence when I tell them what we are trying to do and how - impact patients lives. I used to take it personally. Now I just realize I have to push forward.
We have not partnered with any large pharma to date, and not for lack of trying. We have not brought in any professional investor, and again, not for lack of trying. And I understand. It is very expensive to develop drugs. If the only customer for innovative drug companies is large pharma, then every investor and small biotech has to develop for these large pharma companies. Everyone wants to flip their company to large pharma - they are my industries customers. With drug development costs so high , with so many failures, and so many large pharma focused on only a few areas (all of which I believe are self-induced and a topic for another day), small innovative companies are forced to "get in line" in these areas or perish early for lack of funding/resources. We've been lucky. We've had lots of institutional support (grants, etc.). We are the leading researcher and clinicians in the space. They could have made more money going to industry. We have patients who are owners - alot of patients - and (hopefully) they realize the magnitude of our endeavors.

It is a good question. We'll probably have to address it at some future date. But if you are interested in the industry, look up a few things. Look at the cost of cancer drugs (where most of investor and pharma industry dollars are focused) and look at efficacy, particularly for overall survival of treatments for solid tumors over the last 20 years, look at the NNT (the number needed to treat) of many drugs, look up lobbying dollars compared to other industries, and look up rise in overall costs for drugs. We hope we are doing the right thing and having fun doing it.

brittersbear1 karma

First, thank you for doing this.

Second, what's the cost going to look like when you are finally able to roll this out to the public?

WinSanTor3 karma

We hope we can keep it affordable. What that means we don't know but our goal is that it will be in the thousands of dolllars (in total, annually) rather than in the millions of dollars like some other drugs. We know that drug prices started escalating in the mid to late 2000s. We would like to see our drugs in line with prices back then, adjusted for GDP. Doctors, hospitals and insurance companies seem to like the prices we've estimated (remember, for many of these "stakeholders" - drugs are not revenue generating, just a cost), especially since we are disease modifying treatment.

DoingTimeOnMapleDr1 karma

I developed neuropathy in my feet literally overnight. Turns out I am a diabetic and probably was untreated for about 2 years. My doctor doesn't think it's from the diabetes because of the suddenness of it affecting me. Have you ever heard of this before? My Dr. said it would be more gradual.

WinSanTor1 karma

Surprisingly, yes. This is what is great about our survey. We learn so much about peripheral neuropathy. Please tell us your story at our website in the surveys.

gerritvb1 karma

Hi! Is there any chance that this therapy can apply to recovery from traumatic injuries to nerve tissue? Think ho-hum stuff like car accidents, or even accidental nerve damage during planned surgeries.

WinSanTor1 karma

Possibly. I answered this with another person. But possibly.

Pebbledash21 karma

When do you hope the final trails (phase 3) will start and end?

WinSanTor2 karma

We hope to start phase 3 by next year (internationally) and end, sometime hopefully 2021. This is for diabetic peripheral neuropathy. For other indications, those eligible for breakthrough or other acceleration programs, or for international approval, we may be able to go faster. Depends on how fast we can move in as many different areas we can. We are a really small company.

fcamacv1 karma

Again, appreciate the work you are doing. I wanted to know if you could say more about potential side effects of your drugs. Does it ever make DPN/PN worse in some cases?

WinSanTor1 karma

We did not see any, but it is still early to say.

Austion661 karma

I'm in neuroscience, but I study more macroscopic models of injury/disease. I'm curious as to how well known the pathophysiology behind this phenomenon, and whether you guys are leading any of the research yourself, or relying on others. I'm also curious as to what stage of research you are in-- have you started to look into any treatments as of yet?

WinSanTor2 karma

Yes. We have a pretty good understanding - mitochondrial dysfunction (and recovery). Yes, we are now in Phase 2 with our lead drug.