Omeros Begins Second Phase 2 Clinical Trial For OMS824
By Cyndi Root
Omeros Corporation announced via press release that it has begun the second Phase II trial for OMS824. The phosphodiesterase 10 (PDE10) inhibitor is being studied for Huntington disease, schizophrenia, and other cognitive disorders. The current Phase II clinical trial is for people with Huntington disease. Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, said, "Like treatments for schizophrenia, the only commercially available drug for Huntington's addresses narrowly limited symptoms of the disease and is associated with poorly tolerated side effects. OMS824 holds the promise to expand the therapeutic reach across the disabling aspects of each of these diseases with better tolerability, and we look forward to additional clinical data later this year."
Huntington Disease
Huntington disease (HD) is a brain disorder, most common in adults after age 30. After diagnosis, adults live 15 to 20 years. Juveniles live about 15 years after diagnosis. Patients have involuntary movements and cognitive deficits. In the U.S., about 31,000 people have HD. The Food and Drug Administration (FDA) has only approved one drug (tetrabenazine) for HD.
OMS824
OMS824 has been granted Orphan Drug status by the FDA and has qualified for Fast Track review. OMS824 may improve both the movement and cognitive deficits seen in HD. OMS824 is an enzyme and a phosphodiesterase 10 (PDE10) inhibitor. In a Phase I study, OMS824 occupied PDE10 at 50% without triggering muscle rigidity, involuntary muscle movements, or tremors. A Phase II trial for schizophrenia also showed positive results.
In the second Phase 2 trial for Huntington disease, 120 people will receive a placebo or one of three doses of OMS824. The doses are selected according to patient tolerability and PDE10 target occupancy in the brain. Investigators are interested in improvements in behavior, motor skills, and cognitive abilities. Omeros expects to release interim data in the middle of 2014 and final results in 2015.
About Omeros
Omeros Corporation focuses on the complete drug discovery process including the initial research, development, clinical trials, and marketing. The company researches small-molecule and protein therapeutics. Targets are central nervous system disorders, inflammation, and coagulopathies. Therapeutics are intended for schizophrenia, Huntington disease, addictive disorders, and other cognitive impairments. The company has a GPCR platform, G protein-coupled receptors that mediate physiological processes.
Source: http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-newsArticle_Print&ID=1901101&highlight=