Sentynl Secures U.S. Rights to Mereo’s Alvelestat

Sentynl Therapeutics Inc., a U.S.-based biopharmaceutical company and wholly-owned subsidiary of Zydus Lifesciences Limited, and Mereo BioPharma Group plc, a clinical-stage biopharmaceutical company focused on rare diseases, have entered into an option and license agreement for the U.S. commercial and global manufacturing rights to Mereo’s alvelestat for AATD-LD.

Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 50,000-80,000 individuals in the United States.

The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialize alvelestat for AATD-LD in the United States, with Mereo retaining commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, it provides funding for the alvelestat Phase 3 development program, which could be initiated in early 2027.

“This partnership marks a pivotal moment for Sentynl’s rare disease strategy. Mereo’s alvelestat is a highly promising, differentiated candidate that meaningfully expands our portfolio and has the potential to address an area of significant unmet need,” said Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences Limited. “If approved, alvelestat has the potential to be a meaningful new option that could help their quality of life.”

“We believe Sentynl’s commitment to rare diseases and established commercial infrastructure make them the ideal partner for alvelestat and look forward to collaborating with them during the option period, when we plan to refine the global Phase 3 study design,” said Denise Scots-Knight, Chief Executive Officer of Mereo BioPharma.

Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, would also receive up to $40 million in upfront and R&D payments until NDA filing. Under these terms, Mereo would also be eligible to receive double-digit tiered royalties on U.S. net sales of alvelestat. Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. However, during the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design.