May 26, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Waltham, Massachusetts-based FORUM Pharmaceuticals is laying off 77 people starting immediately, with another 12 job losses possible. There are also unconfirmed rumors that the company may be shutting down.
The layoffs have been in the making for a while. In late March, the company filed with the state regarding layoffs after the failure of a late-stage clinical trial and the resultant restructuring of the company.
In September 2015, the U.S. Food and Drug Administration (FDA) advised Forum to halt its clinical trials of encenicline for Alzheimer’s disease. A small number of serious gastrointestinal (GI) side effects had been observed. A second trial in cognitive impairment in schizophrenia (CIS) has also been placed on clinical hold, but was lifted in November.
On Mar. 24, the company announced results from two Phase III trials in patients with cognitive impairment in schizophrenia being treated with encenicline (FRM-6124). Although the drug met safety standards, it did not meet its co-primary endpoints based on cognitive function and patient function.
The trial showed unexpected high response rates from the placebo group in both trials. As a result, the company announced it would undergo significant restructuring to “appropriately scale its spending and resources and to evaluate a potential path forward, if any.”
Encenicline is an oral, highly brain-penetrant agonist of the alpha 7 receptor found on hippocampal and cortical neurons involved in cognition. The company has a license deal with Mitsubishi Tanabe Pharma Corporation to develop and commercialize encenicline in Japan and other Asian countries.
All of the layoffs, according to the letter submitted to the state, will be at Forum’s headquarters on Second Avenue in Waltham.
In related news, Deborah Dunsire, the chief executive officer of Forum, stepped down and left the company last Friday, May 20. She told Xconomy she planned to take the summer off and had formed a biotech consulting company, Southern Cross Biotech Consulting. “I’m taking the time to look at all the various options and [see] what I really want to do next.”
Although Forum has other products in its pipeline, only FRM-0334 for frontotemporal dementia is in Phase II. FRM-6308 for schizophrenia is in Phase I and a next-generation alpha 7 agonist for cognition and a Y-Secretase modulator for FAD-linked Alzheimer’s disease are in preclinical studies.
It is unclear what the future of Forum is. Dunsire, who reinforced that she is no longer speaking for the company, told Xconomy that if encenicline moves forward, “it would have to be done with a different company or investor,” and that as far as she knew, the company was “in the process of shutting down.”
The company was primarily funded by Fidelity, rather than venture investors.
Forum’s problems underscore the difficulty of developing drugs for Alzheimer’s disease and other neurobiological impairment disorders, such as depression or schizophrenia. Dunsire told Xconomy, “We don’t have the hard endpoints, and that makes drug development extremely difficult…. 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.”
