Omeros, Cambridge Establish New Research Center Dedicated to Complement and Inflammation Disorders

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by Alice Melao |

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OC3IR Omeros OMS721

Omeros Corporation, in collaboration with the University of Cambridge, has established a new research center that will focus on the development of therapies for complement- and inflammation-related disorders, including atypical hemolytic uremic syndrome (aHUS).

One of the main aims of the Omeros Center at Cambridge for Complement and Inflammation Research (OC3IR) will be to better understand the role and response of the immune complement system in blood vessel injury, a process involved in a wide range of human disorders.

This new partnership will also allow the further development of Omeros’ investigational therapies targeting complement activators, the MASP enzymes.

To this end, the OC3IR is currently focusing its research efforts on Omeros’ lead candidate known as OMS721, a human monoclonal antibody designed to block the activity of the MASP-2 enzyme. A Phase 3 clinical trial (NCT03205995) testing this investigational therapy is currently recruiting aHUS patients.

The OC3IR will be led by Wilhelm Schwaeble, PhD, who is an expert in immunology and will be director of research of the new center. He will work closely with other complement researchers, including Peter Lachmann, PhD, who is Emeritus Sheila Joan Smith Professor of Immunology at the University of Cambridge.

“This partnership represents a tremendous opportunity to benefit from the renowned complement and inflammation expertise at Cambridge,” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in a press release.

“Our prior work with Professor Schwaeble proved extremely fruitful, and we expect that this renewed collaboration with him, Professor Lachmann, and their colleagues will enhance and broaden Omeros’ complement franchise of therapeutic targets, antibodies and small molecules. The result, we expect, will be good for Omeros, Cambridge and, most importantly, patients.”

The aHUS trial is expected to enroll approximately 80 adults and adolescents. Patients will receive a loading dose of OMS721 intravenously (injection into the vein), followed by daily injections of the treatment.

Therapy effectiveness will be determined by changes in the number of platelets, as these patients have decreased numbers of these important cells, upon 26 weeks of treatment. The safety of OMS721 will also be evaluated, as well as its stability in the body and immune reactivity. The study is expected conclude in February 2020.

In October, the U.S. Food and Drug Administration granted OMS721 fast track designation for the treatment of patients with aHUS.

Moreover, the therapy has also been granted orphan drug status for the prevention of complement-mediated thrombotic microangiopathies and for the treatment of immunoglobulin A (IgA) nephropathy, and breakthrough therapy designation for IgA nephropathy, hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), and aHUS.

These regulatory designations are expected to support and expedite the clinical development, regulatory review, and approval of the therapy for these different indications.

In addition to the aHUS trial, OMS721 is being tested in two other Phase 3 trials as a potential treatment for IgA nephropathy (NCT03608033), currently recruiting participants, and HSCT-TMA.

Omeros is also developing a second human monoclonal antibody to target the MASP-3 enzyme, a key activator of one of the complement system’s pathways, known as alternative pathway.

The OMS906 antibody is a potential treatment for paroxysmal nocturnal hemoglobinuria and other disorders characterized by increased activation of this particular pathway. It is expected to enter the clinic in early 2020.

“The University of Cambridge has a longstanding history of groundbreaking complement research, and we are excited to join forces with Omeros to continue advancing the translation of complement science,” said Patrick Maxwell, PhD, the Regius Professor of Physic at Cambridge.

“MASP-2 and MASP-3 are unique targets and hold significant advantages over other complement enzymes targeted by investigational or marketed drugs,” he said. “MASP-2 and MASP-3 are increasingly implicated in an expanding array of severe disorders, and we look forward to working with Omeros for the betterment of patients.”