Clinical Trials

In addition to facilitating PFS research, the PFS Foundation monitors FDA trials for products in clinical development that could potentially prove therapeutic for the condition. If you know of any such trials not listed below, please email precchia@pfsfoundation.org.

WinSanTor

This San Diego, C.A.-based biotech firm focuses exclusively on developing treatments for peripheral neuropathy (PN), and is currently seeking input from PFS patients suffering from sexual-sensory disorders—namely, genital numbness.  WinSanTor’s sole product is topical pirenzepine 4% (WST-057). The compound’s active ingredient, pirenzepine, was developed in the 1980s, and marketed throughout Europe and Asia in an oral form to treat gastric ulcers. Over the past decade, the WinSanTor team has demonstrated that topically administered pirenzepine can regrow peripheral nerves damaged by diseases like diabetes, or by treatments like chemotherapy, thus restoring feeling where numbness and pain had set in. While oral pirenzepine (Gastrozepin) has never been available in the US, WST-057 is currently working its way through the FDA pipeline as a remedy for diabetic neuropathy (DN), which affects legs and feet first, then arms and hands, and is estimated to affect 50% of all diabetics—more than 250 million people worldwide. Phase II of the WST-057 clinical trial (A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients With Peripheral Neuropathy), was completed in 2022, and successfully demonstrated that the drug was safe and tolerable in about 60 diabetic patients. That, while regenerating peripheral nerves. Now, as WinSanTor prepares Phase III of its WST-057 clinical trial, the company is also beginning to investigate other possible causes of PN, and if its drug might be an effective therapy for PFS:

Sage Therapeutics

Sage Therapeutics, a biopharmaceutical company based in Cambridge, M.A., has allopregnanolone and allopregnanolone analogue products that are currently in trials for various indications, including major depressive disorder and insomnia. Sage announced an expedited development plan for SAGE-217 in June 2018, following a Breakthrough Therapy meeting with the FDA. The plan is intended to support a potential filing for approval of SAGE-217 in the US for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). “SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from MDD are treated, ultimately turning depression into a disorder, not an identity,” said Sage CEO Jeff Jonas.