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

February 23

Venture capital investors funding novel drug R&D three times more than companies repurposing, improving existing drugs

In appreciation: Karen Woodin will be remembered for her teaching, writing and lasting friendships

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs