Adocia (EPA:ADOC) has cut loose its diabetic foot ulcer program after the drug failed a Phase III trial. The drug, BioChaperone PDGF, was penciled in to start pivotal trials in Europe and the U.S., but weak data from an Indian Phase III study have prompted Adocia to halt all development of the asset.
Lyon, France-based Adocia expressed surprise at the top-line data. The 252-person trial pitted the experimental therapy against standard of care--saline solution--and assessed which was associated with more completed wound closures following 20 weeks of treatment. BioChaperone PDGF failed to clear this bar, resulting in the study missing its primary endpoint. Adocia opened down 9% in Paris.
“Diabetic foot ulcer has proved an extremely difficult condition to address, as seen in multiple recent late-stage clinical trial failures,” Adocia CEO Gérard Soula said in a statement. “The main reason is the lack of uniformity in the standard of care of these types of wounds.”
Over the past 12 months, Derma Sciences ($DSCI) and Israel’s MacroCure ($MCUR) have both posted negative Phase III data on diabetic foot ulcer candidates. Derma scrapped its study following a futility analysis. MacroCure got to the end of its 16-week trial, but failed to show its cell therapy was better than a placebo.
With BioChaperone PDGF joining these drugs on the list of diabetic foot ulcer programs to post weak clinical trial data, Adocia has decided to drop the asset. The decision ends Adocia’s ambition to test the candidate in the U.S. and Europe, and brings the drawn out final steps in the story of the diabetic foot ulcer program to a close.
Adocia posted Phase II data on the asset in 2012, at which time the performance of BioChaperone PDGF against Smith & Nephew’s (LON:SN) Regranex in a 192-person study prompted the French biotech to plan to start Phase III studies in India, the U.S. and Europe within 18 months. That plan proved to be wildly optimistic. While Adocia filed to start a Phase III trial in India in September 2012, turmoil at the country’s regulator meant it took almost two years to get the dossier approved.
The plan was to include data from the Indian trial in a regulatory filing in Europe, enabling Adocia to win approval on its home continent on the back of one local trial. With the Phase III fail scuttling that strategy, Adocia is shifting its attention to the bigger, but earlier-stage, opportunities in its pipeline, notably the Eli Lilly ($LLY)-partnered BioChaperone Lispro.
Adocia and Lilly have established a bedrock of early to mid-phase evidence that the insulin can give diabetics more flexibility in terms of when they take the drug. The next step is to put this to the test in a Phase III trial. Lilly had looked set to advance the drug into Phase III before the end of the year, triggering what Jefferies analysts estimate will be a €40 million ($45 million) milestone payment, but the timing has slipped recently.
In last month’s quarterly earnings call, Lilly said it will start a Phase III trial of an ultra-rapid insulin in 2017, later than previously expected. The use of the term “ultra-rapid insulin” could be telling, too. Lilly has two drugs that fit this description in its mid-phase pipeline, namely Adocia’s BioChaperone Lispro and an internally-developed candidate. Lilly doesn’t name the internal program on its pipeline page, but it has been trialling LY900014 against Humalog over the past 18 months.
The presence of a rival to BioChaperone Lispro in Lilly’s internal pipeline exposes Adocia to the sort of situation Galapagos ($GLPG) faced when awaiting AbbVie’s ($ABBV) decision on filgotinib. In that case, Galapagos appeared to have the more validated drug, but the opportunity to steal a lead in the race to market and free itself from milestone payments proved too attractive for AbbVie to resist.
Adocia now faces a wait until it learns whether Lilly will follow AbbVie’s lead. Lilly had already walked away from Adocia once. In 2013, it canned a partnership struck 18 months earlier, only to enter into a fresh agreement in 2014.