FDA granted Fast Track designation to encenicline

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No Treatment Currently Available for Condition Affecting Nearly All Schizophrenia Patients

WALTHAM, Mass. – June 22, 2015 – FORUM Pharmaceuticals Inc., a biopharmaceutical company singularly focused on the development and delivery of innovative medicines to treat serious brain diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to encenicline, FORUM’s lead compound in development to treat cognitive impairment in schizophrenia. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and to demonstrate the potential to address unmet medical needs. Encenicline is a novel alpha 7 agonist in Phase 3 development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer’s disease. The Company recently completed patient enrollment in its pivotal Phase 3 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.

“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,” said Deborah Dunsire, M.D., President and Chief Executive Officer of FORUM Pharmaceuticals. “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.”

“FORUM’s ongoing Phase 3 COGNITIV SZ clinical trial program recently completed recruitment of more than 1,500 patients, and we expect to announce top-line results from those trials in the first half of 2016,” continued Dr. Dunsire. “Encenicline is also being investigated to treat Alzheimer’s disease, and patient enrollment is well underway in our ongoing multinational Phase 3 COGNITIV AD clinical trial program.”

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Great news thanks.

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What does fast tracking Encenicline practically actually mean? Nothing special as far as I know… It’s still going to be marketed as already planned without fast tracking, around 2017 right?

If so, fast tracking sucks, can’t wait to get my hands on this drug!

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It means it may get a “Priority Review” which takes 6 months instead of 10 so it could be released abbit earlier :).

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I wanna see the drug that can “treat cognitive impairment in schizophrenia.” I’m sorry, by sz is not Alzheimers or even close. The underlying physiology is waaaaaay different.

Though I will say that it may be possible to treat certain physiological conditions that “get in the way” of functional cognition, I have to add that “correcting dysfunctional core beliefs and appraisal-according-to-belief schemas with meds” is pretty likely impossible.

Funny, I just ran into this an hour or so ago on CPN:

Interest in cognitive impairment in schizophrenia is driven, in part, by the recognition that cognitive impairment is more responsible than positive symptoms for the broadly and persistently observed impairments in functioning. Impairments are present in multiple cognitive domains, and most have a robust relationship with functioning.

Lepage M, Bodnar M, Bowie CR. Neurocognition: clinical and functional outcomes in schizophrenia. Can J Psychiatry. 2014;59(1):5-12.

Cognitive impairment is not due to, or secondary to, positive or disorganized symptoms—cross-sectional correlations between positive symptoms and cognition are negligible, while positive symptom improvement is not correlated with cognitive change in clinical trials. In addition, cognitive impairment in schizophrenia is present prior to any pharmacotherapy, and treatment-naive patients demonstrate serious cognitive impairment comparable to that of their treated counterparts. Thus, it appears that impaired cognition is an independent, core neurobiological feature of schizophrenia and should be a therapeutic target apart from reducing psychotic symptoms.

Nasrallah HA, Keefe RSE, Javitt DC. Cognitive deficits and poor functional outcomes in schizophrenia: clinical and neurobiological progress. Curr Psychiatry. 2014;13(6 suppl):S1-S11.

(Henry Nasrallah, who seems to be a tout for Big Pharma much of the time, is hopeful for a medicinal solution, but that figures.)

There are no pharmacologic or behavioral options that have received regulatory approval for the treatment of cognitive impairment in schizophrenia. At present, in the absence of effective treatments, the development of medications to treat cognitive impairment represents a serious public health need. The MATRICS initiative, or the Measurement and Treatment Research to Improve Cognition in Schizophrenia project, is an interdisciplinary collaboration that was initiated by the National Institute of Mental Health (NIMH) to support the development of pharmacologic agents to improve cognition in schizophrenia. Research into multiple pharmacologic mechanisms that may potentially alleviate cognitive impairment in schizophrenia is actively ongoing.

Buchanan RW, Davis M, Goff D, et al. A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia. Schizophr Bull. 2005;31(1):5-19.

http://cognition.currentpsychiatry.com/article/md-iq-quiz-cognitive-impairment-schizophrenia-part-iii

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