Navigation Links
Omeros Announces Successful Completion of PDE10 Phase 1 Multiple Ascending Dose Trial

SEATTLE, March 26, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data from the multiple-ascending-dose (MAD) portion of the Company's Phase 1 clinical trial evaluating OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program. With these data and the previously announced successful single-ascending-dose portion of this clinical trial, Omeros is advancing OMS824 toward a Phase 2 clinical program. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia.

The OMS824 Phase 1 clinical trial was a randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study. The trial enrolled 64 healthy male subjects; 40 subjects received a single dose and 24 subjects received daily dosing for 7 to 10 days. OMS824 was well tolerated by all subjects, and the only apparent drug-related adverse event was mild somnolence at the highest dose evaluated. No subject had extrapyramidal symptoms (e.g., involuntary muscle movements), which are associated with marketed antipsychotic medications and have been seen with other companies' PDE10 inhibitors at levels of approximately 50-percent engagement of the PDE10 enzyme in the brain. A radiotracer imaging study is underway to confirm the target engagement of OMS824 in human brains.

The study results showed that the pharmacokinetic parameters (Cmax and AUC) increased linearly with the dose and that OMS824 had a long half-life that is consistent with once daily dosing. OMS824 was detected in the cerebrospinal fluid at the expected concentration relative to that in the blood. The drug concentration in the cerebrospinal fluid is predicted to achieve near-complete inhibition of the PDE10 target in the brain. These results show that OMS824, at well-tolerated doses, achieves concentrations that are anticipated to effectively inhibit PDE10 and support continuing development for the treatment of Huntington's disease, schizophrenia and other central nervous system disorders.

"These results are exciting – it appears that OMS824 is able to achieve significantly higher concentrations at the target enzyme in the brain than other PDE10 inhibitors being developed across the industry without incurring the movement abnormalities seen with those other compounds," stated Gregory A. Demopulos , M.D., chairman and chief executive officer of Omeros. "While wrapping up the Phase 1 program, we are aggressively advancing OMS824 into Phase 2 trials. Our initial focus will be Huntington's disease, for which we will be requesting orphan drug as well as Fast Track designations from the FDA, and a Phase 2a trial in patients with schizophrenia is expected to follow shortly thereafter. In addition to our progress in the OMS824 program, we plan to submit the NDA next quarter and the MAA mid-year for OMS302, our ophthalmic drug product, and we remain on track to advance our MASP-2 and PDE7 programs into the clinic in the coming months."

About Omeros' PDE10 Program
PDE10 is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition and psychomotor functions, including Huntington's disease and schizophrenia. Huntington's disease is a hereditary neurodegenerative disorder that leads to movement, cognition, and behavioral abnormalities and premature death. Cognitive dysfunction is responsible for substantial disability in these diseases and is not improved by current medications. Omeros' proprietary compound OMS824 inhibits PDE10 and is being developed for the treatment of cognitive disorders. In addition to potential benefits on cognition, OMS824 could also improve psychiatric manifestations, such as the positive (e.g., hallucinations) and negative (e.g., flat affect) symptoms of schizophrenia.

About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates, OMS302 for lens replacement surgery and OMS103HP for arthroscopy, are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has five clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.

Forward-Looking Statements
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding the potential qualities of OMS824; that it will request orphan drug and Fast Track designations for OMS824; that it will advance OMS824 into a Phase 2 clinical program; that it will submit an NDA and MAA for OMS302 this year; that it will advance its MASP-2 and PDE7 programs into the clinic in the coming months; and that Omeros may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2013. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

SOURCE Omeros Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Omeros Elucidates Mechanism of its PDE7 Inhibitors in Addiction
2. Omeros to Present at the Cowen and Company 33rd Annual Health Care Conference
3. Omeros Announces Toxicology Study Data from MASP-2 Inhibitor
4. Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial
5. Omeros Announces Encouraging Data from Phase 1 Clinical Trial for PDE10 Program
6. Omeros to Present at the 24th Annual Piper Jaffray Health Care Conference
7. Omeros is Not Aware of Any Justification for Share Price Movement
8. Omeros Corporation Reports Third Quarter 2012 Financial Results
9. Omeros Responds to Misleading Announcement by Davis Wright Tremaine Concerning Settlement with Former Chief Financial Officer
10. Omeros Ophthalmology Product OMS302 Successful in Second Phase 3 Clinical Trial
11. Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program
Post Your Comments:
(Date:12/1/2015)... BANGALORE, India and ... (NASDAQ, TASE: MYL) today announced that it expects to ... for developing country markets funded by international donors, TLE400 ... + Efavirenz 400 mg) for $99 per patient, per ... (CHAI) to develop TLE400. The significantly reduced price could ...
(Date:12/1/2015)... , Dec. 1, 2015 Breg, Inc ... services, announced today that it has been awarded three ... Members served by Novation will have access to improved ... bracing products and soft goods dedicated to advancing orthopedic ... The aging U.S. population, rising prevalence of chronic ...
(Date:12/1/2015)... , Dec. 1, 2015 Building ... HIV/AIDS, Johnson & Johnson (NYSE: JNJ ) ... Janssen Pharmaceutical Companies to significantly reduce the burden ... make up 74 percent of new HIV infections ... on World AIDS Day, these new initiatives include ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... SAN FRANCISCO, ... announced that the organization has awarded Education and Developmental Therapies (EDT), an Applied ... The award celebrates exceptional special needs providers that excel in synthesizing the areas ...
(Date:12/1/2015)... ... ... Lutronic, a leading innovator of aesthetic and medical laser and energy-based technology, announced ... the United States. Clarity is a Superior Dual Wavelength Platform which combines two ... platform that is easy to own and operate. , For over a decade, ...
(Date:12/1/2015)... , ... December 01, 2015 , ... XTC Semifinals ... 10 semi-finalists to head to Las Vegas for CES 2016, the world’s largest Consumer ... of Consumer Technology Association Gary Shapiro, Founding Partner of Pacific Investments Veronica Serra, and ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... Nurotron Biotechnology ... in its largest order to date. , The order will be from the ... Nurotron’s Venus Cochlear Implant System is an effective solution for children and adults suffering ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... Contact Center Enterprise Authorized Technology Provider (ATP) status from Cisco. This designation recognizes ... and support Cisco Unified Contact Center solutions targeted to the high-end enterprise contact ...
Breaking Medicine News(10 mins):