Omeros Corp (SEATTLE, Washington), a clinical-stage biopharmaceutical company, and Affitech AS (OSLO, Norway), a human antibody therapeutics company, announced that they have entered into an agreement for the discovery and development of fully human antibodies for Omeros’ MASP-2 program. MASP-2 (mannan-binding lectin-associated serine protease-2) mediates activation of the complement system via the lectin pathway and is linked to multiple potential indications across a wide range of inflammatory diseases including rheumatoid arthritis, transplant rejection, macular degeneration, and cardiovascular and renal ischemia reperfusion injury.

Under the collaboration, Affitech will apply its human antibody libraries and proprietary antibody discovery and screening technologies, including its AffiScreen™ platform and engineering methods, to generate high-affinity, fully human antibodies against MASP-2 for Omeros. Financial terms include a technology access fee, a series of milestone payments, and royalties on net sales, payable by Omeros. No further terms of the agreement were disclosed. Omeros holds worldwide exclusive licenses to rights related to MASP-2, the antibodies targeting MASP-2, and the therapeutic applications for those antibodies from the University of Leicester and from its collaborator, Medical Research Council at Oxford University, both in the UK

MASP-2, a novel pro-inflammatory protein target, is involved in the activation of the complement system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage (eg, trauma) or infection by microbial pathogens. MASP-2 appears to be unique to, and required for the function of, a principal complement activation pathway, known as the lectin pathway. Inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical pathway, a critical component of the acquired immune response to infection; abnormal immune response function is associated with a wide range of autoimmune disorders.

Omeros' most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological, and other surgical and medical procedures. Its lead agent, OMS103HP (a proprietary combination of active pharmaceutical ingredients with known anti-inflammatory, analgesic, and vasoconstrictive activities), is being evaluated in phase III clinical trials in the US and Canada for use during arthroscopic surgery to improve postoperative joint function and reduce postoperative pain. Results were recently reported from a prospective, double-blind, vehicle-controlled phase I/II study of 30 patients undergoing arthroscopic allograft ACL reconstruction randomized across two arms to receive either standard arthroscopic irrigation solution or the same solution with OMS103HP added. Patients were monitored for safety and efficacy endpoints were assessed over the 30-day postoperative period. Results of the study demonstrated a statistically significant improvement in knee function, range of motion, quadriceps and hamstring muscle strength, pain management, and return to work in OMS103HP-treated patients. The incidence of adverse events and abnormal clinical laboratory values for the agent and the control arm were similar. If approved, OMS103HP will be the first commercially available agent for the improvement of function following arthroscopic surgery.