Sentynl Therapeutics and Mereo BioPharma have entered an option and license agreement covering U.S. commercial rights and global manufacturing rights for alvelestat, an investigational oral treatment for alpha-1 antitrypsin deficiency-associated lung disease.
Under the agreement, Sentynl has the exclusive right to acquire a license to commercialize alvelestat in the United States. Mereo will retain commercial rights outside the U.S. and lead global development, including the planned Phase 3 study and regulatory interactions through completion of that trial.
Mereo will receive a non-refundable option fee. If Sentynl exercises its option, Mereo would be eligible for up to $40 million in upfront and research-and-development payments through filing of a New Drug Application, along with double-digit tiered royalties on U.S. net sales.
Sentynl, a U.S.-based biopharmaceutical company and wholly owned subsidiary of Zydus Lifesciences, would also receive global manufacturing rights for alvelestat in the AATD-LD indication. Exercise of the option would provide funding for the Phase 3 development program, which could begin in early 2027.
Alvelestat is a neutrophil elastase inhibitor being prepared for Phase 3 testing. If approved, the companies said it could become the first oral treatment for AATD-LD, a rare, progressive genetic respiratory disease estimated to affect 50,000 to 80,000 people in the United States.
The companies will work together during a short option period to advance manufacturing activities and refine the planned global Phase 3 study design. Mereo said the program is supported by positive efficacy data from two Phase 2 studies.
Sentynl Chief Executive Officer Matt Heck said current AATD-LD care can be demanding, often involving generalized therapies or frequent intravenous treatment. He said the company sees an opportunity for alvelestat to improve on existing approaches if the drug is successful in later-stage development.
Mereo Chief Executive Officer Denise Scots-Knight said Sentynl’s rare-disease focus and commercial infrastructure make it a suitable partner to advance the program. Zydus Managing Director Sharvil P. Patel said the agreement expands Sentynl’s rare-disease portfolio and addresses an area of significant unmet need.
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