BioWorld International Correspondent
LONDON - Renova plc experienced the first setback in its wound healing and anti-scarring program, reporting that lead product Juvista missed its primary endpoint in a Phase II mole removal trial.
The product was licensed to Shire plc, of Basingstoke, UK, in June in a potential $825 million deal, of which $125 million already has been received.
However, Renova CEO Mark Ferguson was undaunted by the failure of the trial, stating that the primary endpoint was missed due to "unexpected confounding factors" in the design, which made comparison of treated vs. placebo scars difficult. "There is no impact of the trial's failure," he said in a conference call, adding that the product is on track to begin Phase III development in the second half of 2008.
Ferguson explained that there were methodological problems with the study in that the size and position of the wounds left after removal of the moles varied too much to allow a proper comparison of treated vs. placebo sites.
"Scarring is different, depending on where it is," he said. "You can't compare a drug-treated scar on the head with a placebo-treated one on the neck." In addition, the lengths of wounds varied.
"In other words we didn't meet the primary endpoint because we were comparing different sorts of wounds," Ferguson said.
Manchester, UK-based Renovo said it had some "very useful learning" as a result of the trial, one of 12 in the Phase II development program for Juvista, a product containing transforming growth factor beta-3 as its active ingredient. According to the company, the worst case scenario would be product labeling that does not include mole removal. That specific indication is equivalent to only 2 percent of the projected overall market.
However, the failure does feed skepticism about Renovo's approach to assessing scarring. Ferguson said the company has had several discussions with both European and U.S. regulators about that.
"It is entirely appropriate that Renovo has devised its own endpoints. That's what happens when you move into new therapeutic areas," Ferguson said. There are no approved prescription products for scar reduction currently.
The end-of-Phase-II discussion with the FDA will provide "absolute clarity" on endpoints for Phase III, noted Ferguson, adding, "We don't anticipate any surprises."
The 12 Phase II Juvista trials have covered a number of different body sites, skin colors, ages and sexes. To date, six of those have reported positive results.
The company is well-funded with £100 million in cash, sufficient for three years' operations. It is expected that its second product, Zesteem, for preventing scarring of skin-graft donor sites will overtake Juvista and be first to market. Ferguson said the company will complete development of that product using its own resources before looking for a U.S. marketing partner and setting up its own sales operation to market the product in the European Union.
Zesteem is a formulation of estradiol, which has a long history of use in contraceptives and hormone replacement therapies. Discussions with regulators have indicated that there is an abridged route to market.