Renovo reports Phase II efficacy trial results of skin healing drug

This was an exploratory human proof of concept efficacy trial to investigate different dosing regimens and routes of administration for Juvidex (Mannose-6-Phosphate) to assess the feasibility of developing a topical product targeted for the large cosmetic skin peel market.

The trial was a randomized, double-blind, placebo-controlled Phase II study in 195 male and female subjects to investigate the safety and efficacy of two doses of Juvidex (300mM and 600mM) in the acceleration of healing of small (1.5cm x 2cm) split thickness skin graft donor sites. The trial also included a placebo-controlled standard care treatment arm and was conducted in Renovo’s in-house clinical trials unit.

According to the company, the trial did not meet its primary endpoint, which was demonstration of a statistically significant difference in the time to complete wound closure at the skin graft site as assessed by the investigating physician, comparing Juvidex (administered topically alone and intradermally and topically in combination) to placebo.

Renovo has concluded that the combined intradermal and topical dosing regimen is not suitable for this indication, with the highest dose (600mM), administered by this route, shown to be statistically inferior to placebo.

In addition, Juvidex was generally safe and there were no serious adverse events. Pre-specified secondary endpoints demonstrated statistically significant improvements in wound appearance and acceleration of healing in favor of Juvidex when administered topically, the company said.

These results support Renovo’s plans to develop Juvidex as a topical treatment for the large cosmetic skin peel market. The company will now look to develop an improved topical formulation and delivery mechanism for Juvidex.