Novo Nordisk, Omeros agree to zaltenibart deal for PNH treatment
Phase 2 data show therapy stops internal and external hemolysis
Novo Nordisk has entered a license agreement with Omeros for the development and commercialization of zaltenibart (OMS906), an experimental treatment for paroxysmal nocturnal hemoglobinuria (PNH).
The deal, expected to be close by year-end 2025, will give Novo Nordisk exclusive global rights for zaltenibart in all indications. Once finalized, Novo Nordisk plans to initiate a global Phase 3 program for zaltenibart in PNH.
Under the agreement, Omeros is eligible to receive $340 million in upfront and near-term milestone payments, and up to a total of $2.1 billion for development and commercial milestones, plus tiered royalties on net sales.
“Zaltenibart has a novel mode of action that could offer several advantages over other treatments for complement-mediated diseases,” Martin Holst Lange, MD, PhD, chief scientific officer and executive vice president of research and development at Novo Nordisk, said in a company press release. “Novo Nordisk is in a strong position to build on the work done by Omeros to … develop zaltenibart into a differentiated and potentially best-in-class treatment approach for a number of rare blood and kidney disorders.”
Zaltenibart targets root cause of red blood cell destruction
PNH is a rare acquired genetic disorder in which red blood cells are destroyed because they lack protective proteins. This makes them vulnerable to attack by the complement system — a part of the immune system — leading to anemia and other disease symptoms, such as fatigue, dizziness, and shortness of breath.
Current PNH treatments work by blocking activation of the complement system, thus preventing red blood cell destruction, or hemolysis. However, they also increase the risk of infections.
Zaltenibart is an antibody-based therapy designed to inhibit the MASP-3 protein, specifically blocking a branch of the complement system known as the alternative pathway. This selective inhibition preserves the classical complement pathway, which plays a key role in immune defense, thereby maintaining the body’s ability to combat infections. The treatment is also expected to stop hemolysis occurring both inside and outside blood vessels.
In a Phase 1b proof-of-concept study (NCT05889299), zaltenibart given once a month by under-the-skin (subcutaneous) injection helped normalize markers of hemolysis in people with PNH.
In results from a Phase 2 trial (NCT05972967), which tested the therapy in PNH patients who failed to respond to the approved treatment Ultomiris (ravulizumab), zaltenibart effectively stopped hemolysis occurring inside and outside blood vessels. The treatment also led to improvements in the levels of hemoglobin, the protein that carries oxygen in red blood cells.
“We are pleased to enter into this agreement with Novo Nordisk, a global leader in therapeutic innovation and development,” said Gregory A. Demopulos, MD, Chairman and CEO of Omeros. “We look forward to Novo Nordisk levering its extensive expertise and global reach to unlock the potential of zaltenibart across alternative pathway indications.”
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