Neurim Pharmaceuticals announces first patients’ enrollments in ReCOGNITION – phase II clinical trial of Piromelatine for mild Alzheimer’s disease

Tel Aviv, Israel, September 28, 2016

Neurim Pharmaceuticals (“Neurim”) announced today that the first patients have been enrolled in the ReCOGNITION study of its novel drug, piromelatine, for Alzheimer’s disease (AD).

ReCOGNITION is a Phase 2, randomized, placebo controlled, dose ranging study of Piromelatine (5, 20, and 50 mg daily) versus placebo to determine an effective dose based on efficacy (cognitive performance), safety and tolerability in patients with mild dementia due to Alzheimer’s disease (AD). The 26-week trial will compare once-daily oral doses of Piromelatine to placebo in approximately 500 patients diagnosed with mild AD and treated with stable doses of acetylcholinesterase inhibitors.

ReCOGNITION was designed following pre-clinical studies with Piromelatine demonstrating neuroprotection and neurogenesis potential. Additionally, in a previous phase II study Piromelatine demonstrated improvements in sleep maintenance and specifically, enhanced deep, slow-wave, sleep (SWS).

“Piromelatine is unique in that it has the potential of targeting AD risk factors and β-amyloid pathology, the leading candidate mechanism underlying the disease” Said Dr. Moshe Laudon, VP Drug Discovery at Neurim Pharmaceuticals and adds “There is a growing body of evidence linking reduced SWS, β-amyloid pathology and cognitive impairment. This association sets the ground for a new therapeutic approach for patients with AD.”

“This study is the result of recent developments in AD research that recognize the role of deep sleep in the clearance of excessive amyloid burden from the brain” said Dr. Amnon Katz, VP Clinical Development at Neurim Pharmaceuticals. “We are pleased to be taking this important step to investigate whether Piromelatine would be beneficial in improving cognitive performance in AD patients.”

To learn more about enrolling in the study, please visit Alzheimer’s disease ReCOGNITION research study (www.recognitionstudy.com).

About Piromelatine

Piromelatine is a multi-target-directed melatonin receptors agonist MT1\MT2 and serotonin 5HT1A\D receptors agonist. In preclinical studies Piromelatine demonstrated antidiabetic, antihypertensive, neuroprotective, sleep promoting and cognitive enhancing effects. In phase-I studies piromelatine was found to be safe and well tolerated with dose proportionality PK profile. In phase II study Piromelatine demonstrated beneficial effects on sleep maintenance with no detrimental effects on memory. Piromelatine demonstrates a good potential for the treatment of insomnia, as well as neurological disorders like Alzheimer’s disease.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals Ltd., founded in 1991, is a drug discovery and development company. The company focuses on developing innovative medicines that help patients prevail over debilitating diseases and improve quality of life. Its first approved drug Circadin® is commercially available in more than 45 countries around the world.

Neurim has a strong and innovative product pipeline under clinical development, intended to treat Alzheimer’s disease, dementia, glaucoma and pain.


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