FORUM Pharmaceuticals announced topline results yesterday of its experimental drug encenicline, reporting that it missed primary endpoints in two Phase 3 trials of schizophrenia patients. The drug stimulates α7 nicotinic acetylcholine receptors, and in earlier Phase 2 studies appeared to improve cognition in people with schizophrenia, as well as those with Alzheimer’s disease. FORUM, based in Waltham, Massachusetts, had advanced encenicline to Phase 3 trials for both indications. The Alzheimer’s trials have been on hold since September last year due to severe gastrointestinal problems in some trial volunteers.
The 26-week Phase 3 trials enrolled around 1,500 schizophrenia patients at more than 200 clinical sites around the world (see trial and trial). In its press release, FORUM said both studies missed their co-primary endpoints for improved cognitive and clinical function. The press release hinted at efficacy based on secondary endpoints and in subgroups of patients and noted that data will be presented at future scientific meetings. The release also noted that in both trials, placebo groups improved more than expected.
Encenicline acts by boosting the response of the α7 receptor to acetylcholine (see Nov 2010 conference news). In two Phase 2 trials, the compound improved cognitive function in mild to moderate Alzheimer’s patients on several measures, including the ADAS-Cog and CDR (see Jul 2012 conference news). However, development of the drug for AD has since been sidelined. The Food and Drug Administration put three Phase 3 trials on hold due to those GI problems (see Sep 2015 news). The company has said it is working with the FDA to resolve the problem and resume testing. It is not clear whether the schizophrenia trial findings will affect development plans. At time of writing, FORUM representatives could not be reached for comment.
FORUM also announced it will restructure its organization to “appropriately scale its spending and resources.” Trade magazines reported that the company may lay off two-thirds of its employees (see Xconomy, Boston Business Journal). FORUM is funded by Fidelity Investments, as is Alzforum.—Madolyn Bowman Rogers
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- Rare but Severe Side Effects Sideline Some Phase 3 Encenicline Trials
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