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news.The US Food and Drug Administration (FDA) has granted fast track designation to Forum Pharmaceuticals' lead compound encenicline, which is being developed to treat cognitive impairment in schizophrenia.
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Encenicline is a new alpha 7 agonist currently in Phase III development to treat cognitive impairment in schizophrenia and Alzheimer’s disease (AD).
Recently, the company completed patient enrollment in its pivotal Phase III COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics.
Forum Pharmaceuticals president and chief executive officer Deborah Dunsire said: "We are pleased that the FDA has awarded Fast Track designation for our encenicline development program in schizophrenia, as we believe that it acknowledges the unmet need for a pro-cognitive therapy in patients with this disease.
"Cognitive impairment is a debilitating condition that can severely impact patients’ ability to function effectively in activities of daily living, such as the ability to live independently, to work or attend school, to have relationships and to participate in social interactions and the community.
"Nearly all patients with schizophrenia are affected with cognitive impairment and no therapy is currently available."
The COGNITIV SZ Phase III trial program is comprised of two trials evaluating the safety and efficacy of two oral doses of once daily treatment with encenicline as a pro-cognitive treatment compared to placebo when added to chronic, stable, atypical antipsychotic therapy in people with schizophrenia.
A total of 1,500 patients at about 200 clinical sites have been enrolled in the two global 26-week randomized, double-blind, placebo-controlled trials.
The trials’ primary endpoints include effect on cognitive function as measured by the measurement and treatment research to improve cognition in schizophrenia (MATRICS) consensus cognitive battery (MCCB), and effect on clinical function as measured by the interview-based Schizophrenia Cognition Rating Scale (SCoRS).
Secondary endpoints include the clinical efficacy as measured by the negative subscale of the positive and negative syndrome scale (PANSS), clinical global impression – severity (CGI-S), clinical global impression – change scale (CGI-C), and quality of life, using the EuroQoL-5D (EQ-5D).