RENOVO REPORTS POSITIVE RESULTS FROM SCAR-REDUCTION TRIAL

Renovo has announced positive Phase II clinical trial results for its lead drug, Juvista, in a 12-month proof-of-concept study of scar reduction at split-thickness skin graft donor sites.

Juvista is a therapeutic application of human recombinant TGFß3, which has been shown in clinical trials to markedly improve subsequent scar appearance in the skin. The trial was a fully randomized, double-blind, placebo-controlled study designed to investigate the safety, tolerability, systemic exposure and anti-scarring potential of Juvista in split-thickness skin graft donor sites. Clinical assessment by plastic surgeons at 12 months following administration of Juvista demonstrated a statistically significant reduction in scarring compared with placebo and indicated a permanent regeneration of more normal skin. This trial demonstrates, for the first time, the efficacy of Juvista in the reduction of scarring in large open wounds whose margins are not approximated and sutured.

Juvista was effective given as an injection followed by topical application at the time of surgery and topical application one day later. The study was the first time Juvista has been administered to open wounds and is in contrast to previous trials in incisional wounds closed by suture or steri strips.

Development of a topical formulation of Juvista would offer the prospect of additional indications such as reducing scarring in split thickness skin graft donor sites, grafts and burns which are markets of high medical need. Juvista injection for closed wounds following incisions/excisions, however, remains Renovo's primary target market as this represents the vast majority of surgical procedures.