Omeros Corporation (NASDAQ:OMER) has announced the commencement of phase 3 drug trials for the treatment of a blood condition called atypical hemolytic uremic syndrome (aHUS).
The drug in the trial is a monoclonal antibody known as OMS721 that was approved by the FDA before the Phase 3 trials were initiated. The drug is categorized as an Orphan drug which means that it is used in the treatment of rare conditions. The drug will be used to treat a blood and kidney disease known as thrombotic microangiopathies that is associated with the aHUS condition.
The phase 3 program will be made up of one clinical trial that will involve newly diagnosed patients. The report about the trial indicated that there will not be a control arm for the program, and thus delays are not expected from the collection of safety data for the biologics license application (BLA). The company also reached an agreement with the FDA on the commercialization of the treatment as well as a toxicology and non-clinical safety plan.
Most of the trial programs for OMS721have already been completed, and no significant findings have been found yet. Omeros is expected to start enrolling for the phase 3 trials sometime this year and patients from the phase 2 trials will most likely be rolled over to the phase 3 trials. The company also plans to seek accelerated approval for the treatment in line with the guidance provided by the FDA.
Gregory A. Demopulos, the chairman, managing director and chief executive officer of Omeros stated that the meeting held with the FDA was an important breakthrough for the currently ongoing development program for the drug. He also stated that it strengthens the company’s strategy for commercialization. Demopulos further noted that the company considers claims that have been brought forward by physicians of aHUS patients who feel that there is a need for more treatment options. The company is also working on treatments for other diseases apart from renal disorders and cataracts.