Date: 2011-07-24
Type of information:
phase: 1b
Announcement: results
Company: Neurim Pharmaceuticals (Israel - Switzerland)
Product: Neu-P11 (piromelatine)
Action
mechanism: 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.
Disease: insomnia
Therapeutic area: CNS diseases
Country:
Trial details: 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.
Latest
news: Neurim Pharmaceuticals has announced 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 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.
