US-based Omeros has received regulatory approval to commence a Phase I clinical trial of OMS721, the firm’s lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) programme.
The clinical trial, which will be conducted in Europe, will analyse the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 when administered subcutaneously in healthy patients.
Following this, Omeros plans to conduct another clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome (aHUS), a rare, life-threatening form of thrombotic microangiopathy (TMA).
Enrolment of patients in the initial clinical trial will begin in July.
Omeros chairman and CEO Dr Gregory A Demopulos noted that European regulatory authorities’ clearance has paved the way for the evaluation of OMS721 in humans.
"The lectin pathway appears to play an important role across a wide range of serious disorders.
"The preclinical data for OMS721 are strong, and we continue to drive the clinical development of the antibody," Demopulos said.
The firm has already filed for orphan drug designation to use OMS721 to treat aHUS in the US, and now plans to seek permission in Europe too.
Omeros has the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a pro-inflammatory protein involved in activating the complement system, which is a key component of the immune system and inflammatory response to either tissue damage or microbial infection.
OMS721 selectively inhibits MASP-2 and obstructs only the lectin pathway of the complement system, leaving the classical pathway intact, which represents the acquired immune response to infection.
The company’s earlier preclinical findings show that the inhibition of MASP-2 by OMS721 may have a therapeutic effect in treatment of aHUS and other life-threatening TMAs, as well as in disorders such as age-related macular degeneration, ischemia-reperfusion injury and transplant-related complications.