Renovo restructures, considers options, as Shire halts Juvista collaboration

UK drug developer Renovo Group (LSE: RNVO) has announced restructuring plans, including a sale of the company, after its lead drug candidate - Juvista (avotermin) for scar revision in surgery - failed to meet its primary or secondary endpoints (The Pharma Letter February 14), and partner Shire (LSE: SHP) pulled out of their commercialization collaboration, returning to Renovo the rights to Juvista in the USA, Canada and Mexico.

Renovo has now conducted further exploratory analyses of the results of that trial and its implications for Juvista. This revealed that: no design, technical, execution or analysis problems were found with the trial; that, despite appropriate inclusion criteria in the protocol and real time monitoring of patient selection, considerable unpredictable variation was found in the appearance of the two halves of the revised scar in some individuals; and no meaningful subset of responders was found in the population of scar revision patients.

In light of these findings the company regrettably concludes that the efficacy of Juvista is insufficient to demonstrate significant benefit when tested in a broad population of scar revision patients.  The findings are surprising in view of the results of the Phase I and II trials of Juvista, which, as is typical, were conducted in more restricted, controlled populations, says Renovo.