Dunsire, Forum Search For Answers After FDA Halts Alzheimer’s Trial

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former Fidelity CEO Ned Johnson’s passion and support for Alzheimer’s research.

It existed apart from the Fidelity Biosciences portfolio, more of a “mission oriented business,” as former Fidelity partner Jason Rhodes told me in March.

With its separate status, Forum didn’t have to do deals or woo outside investors to survive. Indeed, Fidelity wanted it to stay private and commercialize its own drugs despite the prohibitive cost.

Under Dunsire, however, there’s a new mandate: find outside investors to lay the foundation for a future IPO. But the star of the portfolio remains encenicline. Should it persevere in either Alzheimer’s or schizophrenia—which doesn’t have any drug approved for cognition—Forum will likely have a blockbuster drug on its hands. And the hypothesis that the drug could impact other diseases like ADHD, depression, and traumatic brain injury could gain traction, as well.

If it fails? All that value disappears, and Forum must focus on its earlier-stage compounds for orphan-type neurological disorders like frontotemporal dementia.

Encenicline is a lot like the cognitive boosters that have won FDA approval for Alzheimer’s. Each is meant to help people think more clearly for longer, and each target different proteins in the brain. Forum believes it has a better solution—longer-lasting cognition boosts, in more patients, without the side effects—based on differences in the target and chemistry between encenicline and those drugs.

Whether the GI problems that have put the drug on hold argue against that belief remains to be seen. It’s unclear, for instance, how long it’ll take for Forum to resolve the issue. Some clinical holds are lifted quickly, such as the one the FDA placed on a cancer immunotherapy trial run by Memorial Sloan-Kettering Cancer Center in 2014. Others can take years, like the 2012 hold on pain drug prospect tanezumab that was lifted just a few months ago.

But Dunsire says the company has the cash to wait out the hold and complete the encenicline trials without raising another round. Safe to say that Alzheimer’s experts will be paying attention to the findings.

“Exactly what was seen here I don’t know and, while it is unfortunate that at least some participants had problems, it is very important information to have,” Tariot says.

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