October 21, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Omeros Corporation , the Seattle-based biopharmaceutical company, has suspended clinical trials of its drug compound OMS824 because of results found in nonclinical trials on rats running in parallel with the trials on people. Omeros’ compound OMS824, a PDE10 inhibitor, is being developed for the treatment of cognitive disorders such as Huntington’s disease and schizophrenia.
Stock prices of the company fell more than 14 percent in early Tuesday morning trading on the news.
The company stated in a press release that the results that have caused the concern were observed in rats, but that, “OMS824 has been well tolerated in all human clinical trials” and that, “Non-human primates exposed to plasma concentrations equal to those in the rat demonstrated no findings similar to the observation reported from the rat study.”
Omeros launched Phase II clinical trials of the OMS824 compound earlier this year for the treatment of patients with Huntington’s disease for a period of four weeks. In parallel, the company began running nonclinical tests for the evaluation of the drug over a longer treatment period. The company submitted preliminary results for the 13-week nonclinical trials to the U.S. Food and Drug Administration (FDA).
After communicating with the FDA, Omeros halted the clinical trials of the OMS824 compound. The FDA has requested that the company further evaluate the nonclinical results of the 13-week study, as well as results from other nonclinical studies that did not yield the “observation” that has caused concern.
“Omeros is further evaluating the data from the nonclinical animal studies of OMS824,” stated Gregory A. Demopulos, chairman and chief executive officer of Omeros, in a press release. “Based on currently available data, we do not believe that the observation in the rats is caused by OMS824. We will work with the FDA and look forward to continuing the Phase 2 Huntington’s trial.”
Huntington’s disease, a hereditary neurodegenerative disorder, and schizophrenia, a group of severe brain disorders characterized by an abnormal interpretation of reality, are both linked to an area of the brain where PDE10 is expressed. The compound OMS824 inhibits the PDE10 enzyme and is being investigated as mechanism for treating the cognitive aspect of both diseases. The U.S. FDA earlier granted Omeros an Orphan Drug designation to evaluate OMS824 in Huntington’s disease, as well as Fast Track designation to treat cognitive impairment in patients with Huntington’s disease.
Omeros has several drugs in its pipeline in addition to the OMS824 compound. The company’s current lead product Omidria (phenylephrine and ketorolac injection) has been approved by the FDA for use during cataract surgery or intraocular lens replacement (ILR). The company plans to launch Omidria in the fourth quarter of 2014.
