Innocoll ($INNL) saw its stock price tumble 44% in after-hours trading as investors digested news of a Phase III flop. The failure of Cogenzia to improve on standard of care in two diabetic foot ulcer trials leaves the future of the candidate in doubt.
Athlone, Ireland-based Innocoll gave the experimental candidate--a collagen matrix that delivers the antibiotic gentamicin--alongside systemic antibiotic therapy and standard ulcer care. Another cohort received a placebo collagen matrix plus systemic antibiotic therapy and standard ulcer care. A third group received just the antibiotics and standard ulcer care. Innocoll used these cohorts across two clinical trials that enrolled 524 and 613 patients.
Neither study delivered positive data. In both cases, the cohort that received Cogenzia was no more likely to achieve clinical cure after 28 days than the placebo or standard of care groups. Innocoll is continuing to analyze the data, but its release of top-line results lacks any reasons to think Cogenzia has a future. Investors responded by driving down the stock price of Innocoll by 44% in after-hours trading. Innocoll had already slipped 28% in the days running up to the data drop.
The setback continues a run of weak data for European biotechs in the indication. Adocia (EPA:ADOC) scrapped its diabetic foot ulcer program in August after it failed to beat a saline solution in a 252-person Phase II trial. And Macrocure, which listed on Nasdaq the same week as Innocoll, swung and missed in a Phase III study last year. That failure sounded the death knell for Macrocure, which was already reeling from another set of disappointing Phase III data.
Innocoll has other opportunities to fall back on. Xaracoll, a treatment for postoperative pain, came through two identical Phase III trials earlier this year. Innocoll submitted a NDA for Xaracoll this week.