Date: 2011-09-28
Type of information:
phase: 1
Announcement: results
Company: Vernalis (UK)
Product: V158866 (fatty acid amide hydrolase (FAAH) inhibitor)
Action mechanism:
Disease: pain
Therapeutic area: CNS diseases
Country:
Trial details: The double-blind, placebo controlled study investigated single and multiple ascending doses and was conducted in healthy male volunteers.
Latest
news: Vernalis has announced positive results from its Phase I trial of V158866, its fatty acid amide hydrolase (FAAH) inhibitor, a novel target with potential application in a wide range of pain and other indications. Both single dose and repeated administration for 7 days across a wide range of doses were found to be well tolerated with no safety concerns identified.
There were few adverse events at any dose, including the highest dose studied, 500 mg once daily for 7 days.
The pharmacokinetics of the compound were found to be straightforward, with good exposures that increased in an approximately linear fashion with oral dosing. There were clear changes in the pharmacodynamic markers (plasma FAAH activity and endocannabinoid concentrations) at all doses studied, including even the lowest single dose (5 mg).
The study has confirmed that V158866 is a potent inhibitor of human FAAH and has identified once daily doses to be tested in future studies in pain and/or other indications.Vernalis intents now to move into a Phase II proof-of-concept study over the next 12 months.
