The FORUM Format
With a new name and a veteran CEO, Deborah Dunsire, FORUM Pharmaceuticals’ flag is waving high in the increasingly solitary struggle against CNS disease.
The cut and thrust between risk and reward stokes the fires of new drug innovation — and some of the industry’s biggest and most incendiary bets are being made by the smallest players. A case in point is the science and image rebranding exercise now underway at privately held, Boston-based EnVivo Pharmaceuticals, which on April 2 gave itself a new name — FORUM Pharmaceuticals, a maxim for networked collaboration – along with a fresh commitment to its promising late stage program on Alzheimer’s disease and schizophrenia.
Fueling FORUM’s business model is the search for novel pathways to treating diseases of the central nervous system. That model is distinctive in its sole focus on one of the challenging areas of drug discovery, with its innumerable scientific riddles and high costs marked by complex, lengthy trials. Why invest all this effort in a therapeutic segment that ranks at the top of the Tufts Center for the Study of Drug Development’s “pain index” of compound success rates and time to market?
According to FORUM CEO and industry veteran Deborah Dunsire, such disproportionate risks simply make the potential gains from therapy that much greater. “The level of unmet medical need surrounding diseases of the brain is immense,” said Dunsire in a recent interview in Pharm Exec. “The average Alzheimer patient experiences nearly a decade of deterioration progressing to mortality. Treatments to reduce that period of dependency carry a measurable public health benefit, in addition to improving patient quality of life, all at less cost to society.”
Late stage promise
That means if the trial is conducted in line with the agreed protocol and meets its designated end points, the FDA is on notice to approve the drug without further delay. And those end points are fairly specific, requiring demonstration of efficacy against the two most prominent metrics used by clinicians in evaluating cognition and functionality in cases of dementia: the AD Disease Assessment Scale Cognitive Subscale [ADAS-Cog] and the Clinical Dementia Rating Sum of Boxes [CDR-SB].
Supporting FORUM in the Phase-III trial are two Japanese partners, Mitsubishi and Tanabe, who will also coordinate all clinical work in Japan. Trial design is now underway and recruitment selection will start shortly. Despite the obvious challenges of finding the right patients for this complex field work, Dunsire is cautiously optimistic that the outcome will lead to a commercial launch for encenicline for both indications later in the decade – perhaps as early as 2016.
Finding that neural spark
As an orally administered small molecule pill, encenicline also seems effective in penetrating the blood brain barrier that limits the efficacy of most drug-based treatments.
Bigger workplace culture
An experienced people manager from her previous stints at Novartis Oncology and as CEO of Millennium Pharmaceuticals prior to its acquisition by Takeda in 2008, Dunsire says institutionalizing a spirit of accountability is the necessity of the moment. “Because we are importing such a large number of people from outside, I am focused on building a distinct company culture – a FORUM culture, rather than the amalgam of experiences that our hires may be bringing from their previous employers. In particular, I want to instill a real passion about this enterprise, grounded in our mission to tackle diseases and conditions that many of our R&D peers have abandoned.”
FORUM is wholly owned by Fidelity Biosciences, the venture capital arm of the mutual fund giant, which gives it an extra measure of stability in addressing these challenges. “Fidelity has given us 100 per cent support for our strategic positioning as a purpose-built enterprise for serious brain diseases,” said Dunsire. FORUM has access to other sources of capital and could file for an IPO, if conditions warrant – but Dunsire says she and her Board find no pressing need for such a course of action right now, but constantly evaluate the environment to see if a change is warranted.
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