The FDA eases up on Forum's schizophrenia program with Alzheimer's trials still on hold

Forum CEO Deborah Dunsire

Forum Pharmaceuticals has gotten out from under an FDA clinical hold on a Phase III schizophrenia study for its lead drug, but the company's efforts to develop the treatment for Alzheimer's disease remain halted.

In September, Forum disclosed that the FDA forced it to halt dosing and recruitment in three ongoing Alzheimer's studies and one trial in cognitive impairment related to schizophrenia after its drug, encenicline, led to "a small number" of serious gastrointestinal side effects, the company said.

Now the FDA has backed off of the schizophrenia program, allowing Forum to get back to work on a 26-week Phase III extension study in that indication. Two earlier-enrolled Phase III schizophrenia studies were unaffected by the hold and are now nearing completion, the company said. If everything goes according to plan, the data from all three studies will support a later FDA application for encenicline in schizophrenia.

But Forum's ambitions in Alzheimer's remain on indefinite delay. The company is now in the process of gathering and analyzing clinical data with plans to make its case to regulators next year, hoping to resume its Phase III program as soon as possible "and define a possible path forward for encenicline in Alzheimer's disease," Forum said.

The drug is designed to stimulate the brain's alpha 7 receptor to boost cognition, improving neurotransmitter sensitivity to boost memory and executive function. Forum, a rare private biotech in late-stage Alzheimer's research, previously reported Phase II schizophrenia results in which encenicline made a statistically significant difference in cognition compared with placebo.

The company, formerly EnVivo Pharmaceuticals, is headquartered in Waltham, MA, and run by former Millennium Pharmaceuticals CEO Deborah Dunsire.

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