After Failed Trial, Forum CEO Dunsire Leaves, Company’s Fate Unclear

Xconomy Boston — 

Deborah Dunsire, the former head of Millennium Pharmaceuticals and a well-known Boston biotech veteran, is no longer the CEO of Forum Pharmaceuticals, Xconomy has learned.

Dunsire’s last day at Waltham, MA-based Forum was on Friday. She told Xconomy she’s formed a biotech consulting company called Southern Cross Biotech Consulting—it isn’t a full-time business, she said—and is taking the summer off.  “I’m taking the time to look at all the various options and [see] what I really want to do next,” Dunsire (pictured) said.

It’s unclear, meanwhile, what will happen to the privately held Forum, which has been bankrolled primarily by a unit of the money management giant Fidelity Investments for more than a decade.

The company’s lead drug, encenicline, has suffered a double whammy of bad news in recent months. The FDA placed a clinical hold on two late-stage studies of encenicline in Alzheimer’s disease last year, and then the drug failed two Phase 3 trials in schizophrenia in March. That has left Forum in a precarious position. None of its other prospects are close to market. When it announced the failed trial in March, Forum had 130 employees and said it would restructure to “appropriately scale its spending and resources and evaluate a potential path forward, if any.”

If encenicline does move forward, Dunsire says, it “would have to be done with a different company or investor.” She stressed that she can no longer speak for the company, but it is her understanding that Forum was “in the process of shutting down.” It’s unclear if that’s still the case and she deferred all additional questions regarding Forum’s current status to the company. When asked if Forum is in fact closing, a Forum spokesperson didn’t confirm or deny it, but in an e-mailed statement instead reiterated, almost verbatim, the same thing the company announced after the trials failed in March: “Forum continues to appropriately scale its spending and resources and evaluate the company’s path forward.”

Calls to several Forum executives weren’t immediately returned.

Dunsire said today that there were some lessons learned from what happened with encenicline. For example, in its two Phase 3 trials in schizophrenia, encenicline produced a “much bigger pro-cognitive effect” than Forum saw in earlier studies, but so did a placebo. Dunsire says that the company might have made a mistake in how often it administered the standardized test—known as the Matrics Consensus Cognitive Battery—meant to measure cognition in schizophrenia patients. “We probably did it too frequently,” she says. “When you do it every month, people get better at it.”

All of this is an example of one of the biggest challenges in developing drugs for psychiatric disorders like depression or schizophrenia, she says: “We don’t have the hard endpoints, and that makes drug development extremely difficult.” That is, there aren’t effective biomarkers that can definitively show, one way or the other, that a drug is working.

“My belief is that in encenicline, there probably is a therapy that could yield something for patients,” she says. “But it would take another trial and it’s not certain that [that is] possible.”

Dunsire wants to be the CEO of another company and says she is “exploring all the many and varied options there are in Boston.” Though she has the most experience with oncology, for instance, she wouldn’t be opposed to trying her hand at another neurology company like Forum, in spite of what was a tough end to a roughly three-year stint as the company’s CEO.

“I’m going to take the summer off first,” she says.

Dunsire spent eight years at Millennium, with five of them coming after Takeda acquired the company for $8.8 billion in 2008. She stepped down in May 2013 amidst a sweeping reorganization at Takeda and resurfaced in a surprising spot two months later—as the CEO of Forum, then known as EnVivo Pharmaceuticals.

Forum is an unusual biotech story. Instead of the typical syndicate of venture backers, it has been mainly been funded by Fidelity, thanks to former Fidelity CEO Ned Johnson’s passion and support for Alzheimer’s research. Forum had no need for deals or outside investors to survive. When Dunsire took the helm in 2013, she planned to find outside investors, however, and shoot for an IPO. But without the success of encenicline, those plans fell by the wayside.