Neurim Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results Of Piromelatine For The Treatment Of Insomnia

Date: Feb-20-2013Neurim Pharmaceuticals have announced positive results from a phase II clinical study
evaluating the efficacy and safety of Piromelatine (Neu-P11), a novel investigational
multimodal sleep medicine developed for the treatment of patients with primary and
co-morbid insomnia. The new results are from a recent double-blind, randomized, placebo
controlled, parallel group, non-confirmatory, sleep-laboratory study. The study evaluated
piromelatine compared to placebo in 120 adult primary insomnia patients ages 18 years and
older.

Piromelatine 20/50mg treatment for 4 weeks resulted in statistically significant and
clinically meaningful improvements relative to placebo in key polysomnographic (PSG)
parameters including Wake After Sleep Onset (WASO) (p=0.02 for both doses) and in
particular WASO for the first 6 hours of sleep (WASO-6h) (p=0.0008 and p=0.04 for the 50
mg and 20 mg groups, respectively). Piromelatine 50 mg also improved Sleep Efficiency
(SEF) (p=0.02), Total Sleep Time (TST) (p=0.02), Total Time Awake (TTA) (p=0.01) and time
in NREM sleep (p=0.028) indicating beneficial effects on sleep maintenance.

Subjective improvements relative to placebo in quality of sleep and total sleep time measured by the
Pittsburg Sleep Quality Questionnaire (PSQI) were also observed, confirming the PSG
findings. Piromelatine enhanced NREM sleep EEG delta power and significantly reduced beta
power (pAbout Piromelatine:

Piromelatine is thought to work through a combination of MT1MT2 (potential sleep
promoting and chronobiotic effects) and 5HT1AD (potential anxiolytic and analgesic
effects) receptors agonism. All potential effects of piromelatine were demonstrated in
relevant animal models. Phase-IA and IB studies of safety, tolerability, pharmacokinetics
and sleep promoting activity of piromelatine demonstrated dose proportionality PK profile,
good absorption and distribution, good safety & tolerability profile across a wide dose
range and provided the first indication for a pharmacodynamic activity of Piromelatine on
sleep maintenance with no detrimental effects on memory.

About Neurim Pharmaceuticals:

Neurim Pharmaceuticals Ltd., founded in 1991 is a drug discovery and development
company focused on the central nervous system (CNS). It's first approved drug, Circadin(R)
- prolonged release melatonin for insomnia is commercially available in more than 40
countries around the world.

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