BPM31510 cream is being developed by Berg Health as a potential treatment for epidermolysis bullosa (EB), a rare genetic disease of the connective tissue characterized by extremely fragile skin that blisters and tears even from minor friction or trauma.

There is no cure for EB, and the only options available currently for patients are daily wound care, pain management, and protective bandaging.

How BPM31510 cream works

BPM31510 cream is the topical formulation of Berg Health’s anti-cancer drug BPM31510, also known as ubidecarenone. Pre-clinical studies have shown that the drug can advance wound healing, although the exact mechanism of how this happens is not well established. It is hoped that the cream also may help with pain management in EB.

BPM31510 cream in clinical trials

The safety, pharmacokinetics, and therapeutic effects of BPM31510 cream are being evaluated in a Phase 1 clinical trial (NCT02793960). The trial, which is a collaboration between Berg Health and the University of Miami, is currently recruiting participants in Florida who have been diagnosed with any form of EB and have at least one active EB wound between 2.5 and 50 cm2 in size, or up to 10 percent of the body surface area. The main objective of this study is to evaluate the safety and tolerability of the cream in patients with EB and to evaluate whether the cream can reduce pain, time of healing, and formation of blisters, improve patients’ quality of life and the skin’s quality of healing, and increase its resistance to trauma.

The cream will be applied every other day or twice a week to the wounded skin, as well as on intact skin. The skin then will be examined with the help of a special microscope called reflectance confocal microscope (RCM) that enables the skin to be evaluated without the need to take biopsies.

The study is estimated to be completed by January 2019, with a final data collection date for primary outcome measure of February 2018.

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