Winsantor Phase 2 small fiber neuropathy drug (WST-057) trial news.

I recieved this newsletter and could not find it posted on the Internet, so I thought I’d post the text. This is a newsletter from a small company, Winsantor, who is testing a topical drug (WST-057) to see if it increases small fiber nerve density (and improve symptoms?) in diabetic patients with peripheral neuropathy. This drug development is eagerly watched by small fiber neuropathy patients.

here is their website:

http://winsantor.com/

here is the Phase 2 clinical trial description…

https://classic.clinicaltrials.gov/ct2/show/NCT04005287


THE NEUROTRANSMISSION August 2023, Vol. 7

It has been some time since we sent out the last newsletter—our apologies. As you know, clinical studies take a long time, but we think the data from the Phase 2 studies has been worth the wait. The results—which we report in this newsletter—suggest we are the first and only company developing a drug to regenerate peripheral nerves. To view the analysis of the data from the Phase 2 studies, read on.


CLINICAL TRIALS
We’ve completed two Phase 2 clinical studies. Phase 2 is a study phase meant to demonstrate safety and more importantly, PROOF OF CONCEPT, which basically means: Does the drug do what it is meant to do? After Phase 2 comes Phase 3, which precedes approval. We have come a long way, but still have a distance to go.

Our Phase 2 data demonstrated unprecedented small fiber nerve growth, or nerve regeneration, after six months of administration of WST-057. Based on this data, it appears that WinSanTor is the first and only company regenerating peripheral nerves in humans. This result supports WST-057 as a disease-modifying drug that works to change the underlying pathology that causes peripheral neuropathy and small fiber nerve degeneration.

The primary objective for Phase 2 studies is safety. The secondary objective is to show efficacy. While generally most of the focus of the Phase 2 program is on efficacy, it is a requirement to demonstrate safety in order to move forward in development.

Not surprisingly, few, if any, adverse events were seen with respect to WST-057. The few events that were seen were related to the formulation drying out the skin, which in most cases, were resolved through the use of a high-quality skin lotion.

The strongest efficacy results observed in the Phase 2 program was the increase in nerve fiber density after six months of drug administration. This data showed that WST-057 not only prevents nerve loss (the placebo lost nerves during the same period), but that nerves were regenerated in the active dose groups.

Interestingly, the sural nerve velocity, which measures large fiber nerve conduction, also showed improved nerve conduction after three and six months of administration of WST-057. Historically, nerve conduction velocity was the good standard for measuring nerve health. We are the first group to show clinically relevant changes for both small fiber nerve growth and sural nerve conduction.

Two of the most common assessments used in clinical settings are the modified Toronto Clinical Neuropathy Score (mTCNS), which combines patient-reported information and physician-directed neurological assessment, and the Utah Early Neuropathy Score (UENS) neurological assessment. After three months of administration of WST-057, both assessments showed strong improvement in the active group, particularly for functions associated with nerve regeneration/repair, such as decreased numbness and weakness. Again, we are one of the first groups to show positive results in symptoms such as numbness and weakness—symptoms usually ignored by the pharmaceutical industry.

Additional endpoints evaluated include quality of life (QoL), temperature sensitivity and activity. Although the sample sizes were too small to show statistically significance in these endpoints, the patients in the active group improved their QoL, could feel temperature changes better and when monitored with FitBit® watches, were walking more (distance and steps) and slept better.

With regard to pain, the WST-057 mechanism of action, does not impact pain like other pain drugs. These drugs might make the pain feel better temporarily, but they do nothing to impact the underlying cause or pathology of the neuropathy.

Our Phase 2 studies were designed to guide the design of Phase 3 protocol. The data from Phase 2 will be presented to the U.S. FDA in August 2023, with recruitment for Phase 3 to begin shortly after the FDA’s response to this data. We will discuss the endpoints and the number of patients necessary to reach statistical significance with the U.S. FDA. Phase 3 will be performed in North America and Europe. We are exploring clinical studies in other regions as well, including Asia, Middle East and Latin America. After Phase 3 is completed, we will review the data and submit for a New Drug Application for approval of the drug.

Being the first is not the easiest—and that is especially true for drug development. We are creating new tools and new processes, changing opinions and perceptions. Our progress is obviously contingent on the FDA and other regulatory agencies buying into our program, but based on the results from our Phase 2, we are clearly on the right track to be the first to develop a disease-modifying treatment.

 

In the newsletter Winsantor also wrote about a quasi "crowd funding" investment path they are pursuing as another source of funding for phase 3 trials. That is new to me. It is thru the site, wefunder.com.

the drug is administered through a topical patch.

Showing nerve regeneration would make for big headlines, I would think.