Commercial-stage biopharmaceutical Omeros (NASDAQ:OMER) Corporation OMER announced encouraging preliminary results from an early-stage study of its MASP-3 inhibitor, OMS906.
The ongoing phase I study is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) administration of OMS906 in healthy adult volunteers.
The phase I study design consists of both single- and multiple-ascending dose cohorts. OMS906, administered up to 5 mg/kg, was well tolerated at all IV and SC doses tested with no apparent safety signals. Single 3 mg/kg IV dose of OMS906 suppresses mature CFD below minimum detectable levels for 4 weeks. The single lowest SC dose of OMS906 suppresses mature CFD at or below minimum detectable levels for 4 weeks.
The dose-dependent PK/PD profile across all cohorts is favorable and supports low-dose, once-monthly or less frequent subcutaneous dosing.
We note that the study is ongoing with additional single- and multiple-dose cohorts to determine the pharmacologic dose range and optimal frequency for subcutaneous administration.
Omeros’ MASP-3 inhibitor program includes potent molecules selectively inhibiting mannan-binding lectin-associated serine protease-3 (MASP-3), the protein activator of the alternative pathway of complement (APC).
The preliminary data validate the function of MASP-3 — the key activator of the alternative pathway — as a regulator of CFD and support the potential of OMS906 as a safe and long-acting therapeutic for the treatment of alternative pathway-related diseases and disorders. The company intends to advance to a phase II study as soon as possible.
The development of the candidate will strengthen Omeros’ pipeline. The stock has increased 12.1% so far this year compared with the industry’s gain of 1.1%.
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The company’s lead MASP-2 inhibitor, narsoplimab, targets the lectin pathway of complement. The Biologics License Application (BLA) for narsoplimab is under priority review with the FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The company recently announced that the FDA will require additional time to review the BLA. The new target action date is Oct 17, 2021.
The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program, with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request.
The agency has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19.
Meanwhile, its marketed drug, Omidria, continues to gain market share in cataract surgery.
Omeros currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks in the healthcare sector include Repligen (NASDAQ:RGEN) Corp. RGEN, Cumberland Pharmaceuticals (NASDAQ:CPIX) Inc. CPIX and Xencor (NASDAQ:XNCR), Inc. XNCR, each carrying a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Repligen for 2021 are up 40 cents.
Earnings estimates for Cumberland for 2021 are up 8 cents.
Loss estimates for Xencor have narrowed 81 cents.
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