Juvidex

Juvidex is a topical formulation of the sugar Mannose-6-Phosphate (M-6-P).

In March 2009 Renovo reported the results of a double-blind, placebo-controlled, randomised Phase 2 efficacy trial in 195 male and female subjects to investigate the safety and efficacy of two dose levels of Juvidex (300mM and 600mM) via two routes of administration (intradermal and topical in combination and topically alone) in the acceleration of healing of split thickness skin graft donor sites.

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

Although 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, it did meet some of the pre‑specified secondary endpoints with statistical significance. These included a comparison between patients using an external panel of clinical experts to assess photographs of the donor sites, where the 300mM Juvidex topical alone application versus standard care showed a statistically significant acceleration of healing (p=0.0146) in favour of Juvidex. In addition objective measures demonstrated that over the healing period wounds treated with topical Juvidex alone had an appearance that more closely resembled normal skin compared to placebo (p<0.05).

Following this positive proof of concept clinical trial Renovo plans to partner Juvidex as a cosmetic ingredient for the improvement of skin appearance and to promote the healing of damaged skin. Renovo is actively seeking a suitable cosmetic partner to ensure the rapid development and commercialisation of Juvidex.