Omeros reports narsoplimab data and highlights from CMC meetings

Omeros (NASDAQ:OMER) reports an update on clinical data from its pivotal trial of narsoplimab, a human monoclonal antibody targeting mannan-binding lectin-associated serine protease 2 (MASP-2) in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), markedly exceeding the FDA-agreed threshold for the primary efficacy endpoint.

Primary Endpoint: 15% is the FDA-agreed efficacy threshold for the primary endpoint (i.e., the complete response rate (CRR) in the clinical trial).

The CRR for the study population, and the lower limit of the 95% confidence interval (95% CI), significantly exceed the efficacy threshold.

Secondary Endpoints: The 100-day survival is 68% in all treated patients, 83% in patients who received at least 4 weeks of narsoplimab treatment, and 93% in patients who responded to narsoplimab treatment.

Recent FDA meeting highlights and CMC updates:

FDA confirmed that the number of HSCT-TMA patients enrolled is sufficient for the BLA’s filing and review for approval. FDA agreed to stopping enrollment.

The Agency requested near-term manufacturing dates for narsoplimab.

FDA and Omeros’ reached agreement on CMC requirements for stability data and release assays.

In addition to its HSCT-TMA program, Omeros is enrolling its narsoplimab Phase 3 clinical trials for immunoglobulin A nephropathy and atypical hemolytic uremic syndrome .

Shares were up 15% premarket.

https://seekingalpha.com/news/3547988-omeros-reports-narsoplimab-data-and-highlights-from-cmc-meetings-shares-up-15-premarket