FORUM Pharmaceuticals Inc. today announced topline results from two Phase 3 clinical trials in patients with cognitive impairment in schizophrenia (CIS). While encenicline (FRM-6124) demonstrated a favorable safety and tolerability profile in both studies, neither study met its co-primary endpoints based on effect on cognitive function and patient function.
“These results are not what we might have hoped for on behalf of patients. We wish to thank over 1,500 patients who participated as well as the investigators at more than 200 clinical sites,” said Deborah Dunsire, MD, President and CEO of FORUM.
An unexpectedly high placebo response was observed in both trials. Activity was observed across certain sub-groups and secondary endpoints, and these results are being further analyzed.
FORUM expects to share further data from both studies at a future scientific meeting.
An interesting read. It’s not even sure if the drug failed (they found a subgroup who responded and the drug being beneficial for secondary endpoints) or the study design have failed due to high placebo response. The main problem FORUM is facing now with Encenicline for schizophrenia is whether there will be invested money in FORUM to be able to sort this out. Even though little, there is still hope for Encenicline.
And in my opinion Encenicline is one of those (new) drugs that should not be written off because it might be potent enough to help many schizophrenics, just not all.