A New Possible Neuropathy Drug - Trial starting now.

Posted by crossette @crossette, 3 days ago

Maybe some of you got this email today from WinSanTor. Seems worth looking into. I have not read the Phase 2a journal article yet.
Link is below.
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While the "Biotech Bust" and the fallout of COVID-19 were shutting down companies across the industry, we were navigating a landscape that often prioritizes short-term symptom management over long-term solutions. Big Pharma often looks for the "easy" path. We have chosen to go against the grain. We are pursuing a treatment designed to target the underlying biological markers of nerve health - a path that is harder to fund, but one we believe is vital for the 40 million Americans and hundreds of millions globally living with neuropathy. We stayed in the fight because the data told us to.

Scientific Validation: The Lancet Publication

This past year, our mission reached a major milestone. Our Phase 2a clinical data was published in eBioMedicine's The Lancet - one of the most prestigious medical journals in the world.

Link to read the full study:
https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00499-2/fulltext
This is a profound moment of peer-reviewed validation. The study reported objective evidence of increased intraepidermal nerve fiber density (IENFD) in treated patients. While we continue the rigorous work of Phase 3, having this data recognized globally provides the scientific foundation we need to keep moving forward.

Montana’s SB 535, Right to Try law

We are choosing the fastest path to reach you - as early as this summer. While we previously explored traditional federal programs, we found they often carry "one-size-fits-all" bottlenecks that aren't ideal for a drug like ours. Because WST-057 is a topical treatment with established safety data, it is the perfect candidate for a more modern, streamlined approach.

We are shifting our focus to Montana’s groundbreaking SB 535 regulation. This "Right to Try 2.0" framework is much more suitable for our mission because it explicitly supports treatments for severely debilitating diseases like peripheral neuropathy, rather than just terminal ones. It allows for Experimental Treatment Centers that prioritize patient autonomy and medical freedom. WinSanTor is proud to be a pioneer in this program, and we are collaborating with state officials to help establish the operational framework that will allow eligible patients - from anywhere in the world - to travel to Montana to seek access to WST-057.

This renewed optimism is bolstered by a shifting tide in Washington. The current administration (FDA/HHS) has signaled a move toward "modernizing biology" and cutting the red tape that has historically stalled progress for debilitating diseases. With leadership focused on clearing paths for breakthrough treatments, the alignment between state-level freedom and federal flexibility is exactly what a drug like ours needs to move forward.

Sign Up for our Right to Try Progam

How to Get Ready: Your Checklist for Access

To prepare for the launch of the Montana program and potential expansions into other Right to Try states, please follow these three steps:

Coordinate with Your Physician: Your treating doctor must certify that you have a severely debilitating condition and have considered standard options. Share The Lancet publication with them; it provides the peer-reviewed evidence they need to support your request.

Verify Your Eligibility: Under the Montana framework, patients must provide informed consent and acknowledge the experimental nature of the treatment. This is a program for those seeking to address the underlying disease, not just manage pain.

Prepare for Travel: Montana’s program requires your physical presence at a licensed Experimental Treatment Center. Start considering the logistics of travel now. We are also working to bring similar programs to other regions for those who cannot travel to Montana.

Join the Mission

We’ve survived the "biotech winter," and now we need this community to be as proactive as we are. You have a voice that the industry cannot ignore. We are asking you to do one thing today that costs $0 but builds massive momentum:

Tell 5 people about the pioneering Montana Access Pathway

Forward this email to 5 people you know who are seeking new options.

Share our Sign-Up Link in your support groups.

Tell your physician about the Montana framework and our publication in The Lancet.

When you share this, you help us demonstrate the massive, global demand for new pathways in nerve health. That "patient power" is what helps us secure the remaining resources to finish our Phase 3 journey.

Thank you for standing with us. We are the underdog, we have the data, and with your voice, we have a clear path forward.

Warm regards,
The WinSanTor Team
WinSanTor, Inc.
7220 Trade St., 92121, San Diego

Interested in more discussions like this? Go to the Neuropathy Support Group.

cgs | @cgs | 2 days ago

Is this drug a new pain medication or does it have something to do with rejuvenating nerves or repairing damaged nerves

joanland | @joanland | 2 days ago

In reply to @cgs "Is this drug a new pain medication or does it have something to do with rejuvenating..." + (show)

@cgs In looking at the reprint, I see that this study has not yet been approved for use in humans; it is not even in a trial in humans. At present, it's trials are in rats. I think it is a long way from being ready to be tested in humans.

slowrunner1 | @slowrunner1 | 2 days ago

In reply to @joanland "@cgs In looking at the reprint, I see that this study has not yet been approved..." + (show)

@joanland

Hi Joan:
It is interesting that they characterise themseves as "the underdog" - even after receiving 40 million$ in government support (according to their website). I wonder why.

artemis1886 | @artemis1886 | 2 days ago

This has been out for two years. Trial two has not started. If you look up the information about this is not the first posting. We have been waiting for trail two forever. You do not mention the price they are charging people for the trial. This is for people only with diabetes not people with autoimmune neuropathy. You need to clarify that for other people. Study is done in rats not humans. The study is in Canada and US cost is over 800.00. This drug is used in peptic ulcers. If you truly read up on it. These studies are on rat and mice NOT humans. Neuropathy progresses it gets in you bladder including your heart.
https://pubmed.ncbi.nlm.nih.gov/3928324/
Plus
https://www.sciencedirect.com/topics/medicine-and-dentistry/pirenzepine
https://www.winsantor.com/partnerships
https://www.winsantor.com/science

cgs | @cgs | 2 days ago

In reply to @joanland "@cgs In looking at the reprint, I see that this study has not yet been approved..." + (show)

@joanland Loma Linda medical center in Loma Linda California has a neuropathy clinic that is non-invasive non-surgical and it's non-drugs they work on rejuvenating the nerves and and bringing strength and life back into the nerves and in the body and oxygen and blood flow and they check for different things that cause inflammation the ultrasounds and food sensitivities and stuff like that You check into their program they do give or they did at least a bit free video calls and they will talk to you about your situation

megidigo | @megidigo | 2 days ago

First time poster but have been reading this forum for awhile simce suffering with severe neuropathy. IDiagnosed sort of recentlyish but feels like a lifetime. If you read the the copied email in the original postr it says they have done studies in humans not just rats and provide a link to an article in the Lancet that references it.

Its the phase 3 trials that havent started and as far as I know they arent available in Canada even though Winsantors research has been going for ten years in Winnipeg and Toronto Canada. (WINsanTOR) San is for Sanfrancisco where their headquarters are. When I was diagnosed with this awful disease and found out about Winsantor I was pretty excited but not so much anymore. Ive tried contacting them but they do not respond. Their listed info doesnt go anywhere and Ive never received an email despite signing up multiple times. Also when looking at their professional LinkedIn account it seems to be that there is only nine people working in the company. Not reassuring. They also attempted a GoFund me (also not reassuring) which did not succeed.

It seems as the drug may work as per published studies online and as per the Lancet article but I dont know what to think about it anymore. Is it just false hope and is this company just hoping to strike it rich by selling to a real pharma company or something? Something just seems weird about the whole thing. Its been over ten years. There has hardly been any updates well except for this one I guess. You would think that their contact would have someone answering or to voicemail ya know? Makes me wonder if they even have an office. My case is severe enough that I doubt it would even help if it does come out. Oh and I have tried to apply to their phase 3 trials and have NEVER received a response. I really think they are just stringing people along at this point and hoping for a big payday and they are not this David vs Goliath (Big Pharma) as they try to present themselves. I hope Im wrong but something just seems weird about it.

Maybe someone here has more info but their studies do seem to be real at least. Anyways thats my first post as I came upon this as I was browsing the neuropathy forum here. I despise this disease and every day I hear the doctors voice “Theres nothing that can be done” after my EMG. I had never heard of this disease at that point. He actually didnt explain anything to me and I had to make an appt with my primary to find out more and they didnt help much either. This is what led me to finding out about Winsantor and getting a little hope but that is diminishing as well.

arcuri24 | @arcuri24 | 1 day ago

In reply to @cgs "@joanland Loma Linda medical center in Loma Linda California has a neuropathy clinic that is non-invasive..." + (show)

@cgs
This Loma Linda Medical Center sounds unique. I would like to know more about it because I had a shin shave biopsy that has not healed right and I feel that perhaps scar tissue is impacting my nerves. Because I have neuropathy I cannot take cortisone shot. I have been to several doctors and they basically pass the buck. I need to get some kind of ultrasound or MRI neurography to find out what is going on inside my shin. It is really affecting my quality of life.