Mereo BioPharma’s asset, dubbed alvelestat, is set to enter Phase 3 development for AATD-LD in 2027.
Sentynl Therapeutics now has the chance to take charge of the future U.S. commercialization for Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin deficiency-associated lung disease, a rare and genetic respiratory disorder.
Under a Tuesday agreement, Sentynl paid an undisclosed fee for the exclusive option to market Mereo’s drug, called alvelestat, in the U.S. If Sentynl exercises that option, it will pay $40 million to Mereo, covering the deal’s upfront and R&D payments until the submission of a new drug application for the asset.
Sentynl, a subsidiary of Indian multi-national Zydus Lifesciences, has also offered up to $435 million in potential milestones to Mereo, plus double-digit tiered royalties on net U.S. sales of alvelestat. Sentynl is headquartered in California.
Alvelestat is a small molecule blocker of the neutrophil elastase enzyme, which plays a key role in inflammation and has been implicated in the destruction of lung tissue, according to Mereo’s announcement.
The oral drug is being developed for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), which arises from lack of the AATD protein that under healthy conditions protects the lungs against damaging enzymes like neutrophil elastase. Symptoms include shortness of breath and chronic coughs, progressing to asthma and bronchiectasis. Around 50,000 to 80,000 patients in the U.S. have AATD-LD.
Phase 2 data for the asset, released in May 2023, showed an 83.5% reduction in neutrophil elastase activity for the lower dose of alvelestat, ramping up to a 93.3% suppression in the higher dose group. Both effects were significantly superior to placebo, Mereo said at the time.
The biotech subsequently aligned with the FDA on a Phase 3 design for alvelestat but in January 2024 said that it was looking for potential development partners to take the asset forward. The Sentynl deal on Tuesday will help Mereo initiate its late-stage program, which could be launched early next year, according to the release.
