Phase II Clinical Trial for Treatment of Mild Alzheimer's Disease

U.S. Study Participants Aged 60 to 85 with Mild Dementia Needed

TEL AVIV, March 7, 2017 /PRNewswire/ - Neurim Pharmaceuticals Ltd. announced today that they are seeking up to 500 U.S. patients with mild Alzheimer's Disease for the start of a Phase II Clinical trial of a new drug treatment that has the potential to slow the progression of early-stage Alzheimer's Disease. 

The trial, named ReCOGNITION, was designed after pre-clinical studies showed the investigational drug Piromelatine works on the connection between poor sleep and a worsening condition in Alzheimer's. Initially developed as a sleep aid, Piromelatine is now being studied to review its effectiveness in improving cognitive function and slowing cognitive decline through the promotion of better sleep.

"This study is the result of recent developments in Alzheimer's Disease research that recognizes the role of deep sleep in clearing excessive beta-amyloid from the brain," said Dr. Amnon Katz of Neurim Pharmaceuticals. (Beta-amyloid clusters form the "sticky" toxic protein plaques that develop in the brains of Alzheimer's patients.) "There is a growing body of evidence linking compromised sleep with these plaques and with cognitive decline. This connection suggests a new approach in treating patients with Alzheimer's", added Dr. Moshe Laudon of Neurim Pharmaceuticals.

Researchers are seeking patients aged 60 to 85 who have been diagnosed with mild dementia due to Alzheimer's Disease. Participants will be seen by a doctor and will receive all study-related care and medications at no cost. The trial will take place at approximately 75 sites throughout the United States.  Patients and caregivers can learn if they're eligible for the study at www.recognitionstudy.com.

ABOUT PIROMELATINE

Piromelatine, a novel investigational multimodal sleep medicine, is developed for the treatment of patients with primary and co-morbid insomnia. Piromelatine is thought to work through a combination of MT1 and MT2 (sleep-promoting effects, neuroprotective effects) and 5-HT1A/D (antidepressant and anxiolytic effects) receptors agonism. Piromelatine is thought to have good potential for the treatment of insomnia, as well as neurological disorders such as Alzheimer's Disease.

ABOUT the ReCOGNITION Study

ReCOGNITION is a Phase II, 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. The 26-week trial will compare once-daily oral doses of Piromelatine to placebo in approximately 500 patients diagnosed with mild Alzheimer's and treated with stable doses of acetylcholinesterase inhibitors (e.g., Aricept, Exelon and Razadyne).

ABOUT NEURIM PHARMACEUTICALS

Neurim Pharmaceuticals Ltd., founded in 1991, is a neuroscience drug discovery and development company creating drugs for brain restoration and reinforcement, focusing on the central nervous system. Its first approved drug, Circadin^® for the treatment of insomnia, is available by prescription in more than 45 countries around the world. The company focuses on the diseases of aging, such as insomnia and neuro-degenerative diseases like Alzheimer's and dementia, with the goal of improving quality of life.

SOURCE Neurim Pharmaceuticals Ltd.