- Micro cap Omeros (NASDAQ:OMER +5.9%) perks up on 60% higher volume in response to its announcement of positive results from a Phase 2 clinical trial assessing lead product OMS721 for the treatment of patients who have thrombotic microangiopathy (TMA) associated with a hematopoietic stem cell transplant (HSCT), a condition with a high mortality rate. TMA means that there is damage to the smallest blood vessels and blood clots are involved.
- The data showed clinically meaningful improvements in measures of red blood cell destruction, specifically, lactate dehydrogenase (LDH) and haptoglobin levels, following treatment with OMS721 for up to eight weeks. In three patients who completed treatment, the average LDH level decreased as much as 43% from baseline (672 U/L to 380 U/L; p<0.01) and haptoglobin levels increased almost five-fold (1.54 g/L from 0.33 g/L; p<0.06). Both are biomarkers for hemolytic anemia. Mean platelet count increased as much as three-fold from baseline (57,000/uL from 18,000/uL).
- No significant safety signals were observed. According to ClinicalTrials.gov, the estimated study completion date is June 2018.
-
OMS721 is the company's lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies, including atypical hemolytic uremic syndrome (aHUS), a condition that was approved by the FDA for Alexion Pharma's (ALXN) Soliris (eculizumab) in September 2011.