Forum Pharmaceuticals CEO Deborah Dunsire has left the private company, coming after the FDA put a hold on two of its Alzheimer’s trials last year for its lead candidate--which also flubbed two late-stage schizophrenia studies in March.
Xconomy reports that Dunsire left Waltham, MA-based Forum last Friday, 3 years after becoming its chief, and that she has now formed a biotech consulting company called Southern Cross Biotech Consulting.
She said however that she will take some time off before running the firm, telling the news service: “I’m taking the time to look at all the various options and [see] what I really want to do next.”
Its lead drug encenicline is in limbo given the ongoing regulatory hold in Alzheimer’s and recent failure in schizophrenia, but Dunsire added that further trials: “Would have to be done with a different company or investor […] My belief is that in encenicline, there probably is a therapy that could yield something for patients. But it would take another trial and it’s not certain that [that is] possible.”
The FDA slammed the brakes on the late-stage Alzheimer's development program for encenicline in September after investigators reported a "small" number of serious gastrointestinal adverse events among patients taking the drug.
Around 99% of all Alzheimer drugs have failed over the past decade, and has even hit big players such as Eli Lilly ($LLY) and Pfizer ($PFE) in recent years.
In its schizophrenia trials, encenicline failed to meet both of its co-primary endpoints on cognitive function and patient function, something the company partly blamed on “unexpectedly high placebo response was observed in both trials.”
While not formally speaking for her former company, she told Xconomy that Forum was “in the process of shutting down.” She was formerly the head of Millennium Pharmaceuticals, which was subsumed by Takeda in 2008.
Forum is not commenting on Dunsire’s comments.
-see Xconomy’s original story