Omeros ($OMER) is blueprinting a Phase III program for its lead drug after disclosing some positive data from an ongoing mid-stage trial, news that sent the biotech's share price soaring.
The antibody therapy, OMS721, is designed to clear blood clots from bodily organs, treating a group of very rare ailments called thrombotic microangiopathies, or TMAs. In new results from a small, three-pronged Phase II trial, patients getting the middle dosage of Omeros' injected treatment charted an increase in platelet counts, lower dangerous blood cell fragmentation and a boost in the blood protein haptoglobin, the company said.
Omeros is still enrolling the high-dose arm of the study, but the one patient who has completed four-week OMS721 therapy showed signs consistent with both the middle group and the low-dose cohort disclosed earlier this year, the company said.
On the safety said, Omeros said there have been no serious drug-related adverse events tied to the antibody. Two possible safety roadblocks identified in the first patient group amounted to nothing upon investigation, according to the company, and no further infection scares have since arisen.
Now Omeros believes it's on track to start mapping out a Phase III study for OMS721, expecting its 9-patient Phase II trial to spotlight an ideal dose for late-stage development. The new data sent Omeros' shares up about 65% on Tuesday.
OMS721 secured the FDA's fast-track designation last month, promising access to top agency officials and giving Omeros a shot at winning an accelerated approval for the treatment.
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