Neurim Pharmaceuticals announces positive results from phase I and Ib clinical trials with Neu-P11, a sleep maintenance drug

Tel Aviv, July 24, 2011

Neurim Pharmaceuticals Ltd. announced today positive results from a Multiple ascending dose (MAD), safety, pharmacokinetics, and pharmacodynamics phase Ib study of its new investigational insomnia drug Neu-P11.

A first-in-human (FIH), single ascending dose study completed on June 2010 demonstrated the safety tolerability, pharmacokinetics and pharmacodynamics of Neu-P11 in 32 healthy male volunteers. Ascending single Neu-P11 doses of 5mg, 20mg, 50mg, and 200mg were found to be safe and well tolerated in subjects. Sleep promoting effects were also demonstrated. The most frequently reported AE was headache of mild intensity and short duration.

The MAD study was a double-blind placebo-controlled cross-over multiple ascending dose study of Neu-P11 tolerability, pharmacokinetics and pharmacodynamics in 25 insomnia patients aged 18-80. Patients were treated by ascending doses of 2mg, 5mg, 20mg and 50mg Neu-P11 and placebo nightly for 6 days with 1 month washout between treatments. The study confirmed that Neu-P11 is generally safe and well tolerated with a pharmacokinetic profile typical of a short acting hypnotic drug (T1/2 1.2-2.9 hrs) with no evidence of accumulation. Despite the relatively small number of patients (6/group), the data demonstrated significant dose-dependent improvement in sleep continuity outcomes (fragmentation index and number of awakenings) with Neu-P11 compared to placebo. Sleep latency, subjective outcomes of sleepiness (Karolinska Sleepiness Scale-KSS) and sleep quality (the National Sleep Foundation Sleep Diary -NSFSD) also tended to improve at the higher doses. Neu-P11 had no detrimental effects on memory consolidation or sleep structure. Together with the preclinical findings the results of this study make Neu-P11 a plausible candidate for the treatment of primary and comorbid insomnia particularly fibromyalgia, chronic fatigue syndrome and irritated bowl syndrome.

“We are encouraged by these results” said Dr. Moshe Laudon, Director Drug Discovery of Neurim, “These findings indicate that the compound was safe and well-tolerated across a broad dose range and provides a proof of principle of efficacy of this drug in insomnia” Dr. Amnon Katz, Manager Clinical Trials of Neurim said, “We’re moving rapidly toward the initiation of our Phase II insomnia trial with Neu-P11. We’ve built the groundwork for getting into Phase II quickly with solid pharmacodynamic results from our prior single ascending dose study in healthy volunteers and this multiple ascending dose study in patients.

About Neu-P11

Neu-P11 is a novel compound under development for the treatment of primary and comorbid insomnia.
Neu-P11 is a novel drug developed for insomnia and pain. It is a melatonin, serotonin 5-HT-1A and 5-HT-1D receptors agonist, low affinity 5-HT2B antagonist and P2X3, TRPV1 and Nav1.7 channels inhibitor. In relevant animal models Neu-P11 demonstrated potential efficacy in the central sensitivity syndrome, sleep maintenance, pain, gut motility, anxiety and depression.
Neu-P11 is a multi-facet drug addressing a wide range of potential indications including, but not limited to, insomnia, IBS and fibromyalgia.
It is currently entering Phase II development for the treatment of insomnia associated with pain.

About Neurim Pharmaceuticals

Neurim Pharmaceuticals is headquartered in Israel with offices in Switzerland and the UK. The company was founded in 1991 and is focused on the central nervous system (CNS), primarily in age-related disorders.

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