Omeros files IND application for lead compound in schizophrenia program

Monday, September 10, 2012 11:54 AM

Omeros, a Seattle-based clinical-stage biopharmaceutical company, has filed an Investigational New Drug Application (IND) with the FDA to initiate clinical trials evaluating OMS824, the company's lead compound from its phosphodiesterase 10 (PDE10) program for schizophrenia and other cognitive disorders.

OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to diseases that affect cognition, including schizophrenia and Huntington's disease. The first clinical trial evaluating OMS824 is expected to commence following the FDA's review of the IND. This phase I dose-ranging study will evaluate the drug's safety, tolerability and pharmacokinetics in healthy subjects and, assuming timely clearance by the FDA, Omeros plans to begin enrollment in the fourth quarter of 2012 with data expected before year end.

"OMS824 represents the first new chemical entity developed wholly within Omeros that has progressed from discovery through preclinical development and is now poised to enter the clinic, underscoring our in-house capabilities to generate promising novel compounds and build them into clinical assets,” said Gregory A. Demopulos, M.D., chairman and CEO of Omeros. “Together with our phase I trial results for OMS824, we also expect to announce data later this year from our two ongoing phase III clinical development programs, OMS302 for ophthalmology and OMS103HP for arthroscopy."

Share:          
CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

Already a subscriber?
Log in to your digital subscription.

Purchase the June issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs