Zydus’ Sentynl enters option and licence deal for alvelestat

Sentynl Therapeutics, a US-based biopharmaceutical company and wholly owned subsidiary of Zydus Lifesciences, and Mereo BioPharma Group, a clinical-stage biopharmaceutical company focused on rare diseases, have entered into an option and licence agreement for the US commercial and global manufacturing rights to 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 licence agreement grants Sentynl the exclusive right to acquire a licence to commercialise alvelestat for AATD-LD in the United States, while Mereo will retain commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and, on exercise of the option, provides funding for the alvelestat Phase 3 development programme, 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. “AATD-LD has a profound impact on patients’ lives. If approved, alvelestat has the potential to be a meaningful new option that could help their quality of life.”

“We take great pride in having built a sustainable approach for developing therapies for ultra-rare conditions, and this partnership allows us to expand that strategic focus to a larger population within the rare disease community, enabling us to help more people,” said Matt Heck, Chief Executive Officer of Sentynl Therapeutics. “For patients with AATD-LD, the current standard of care is demanding, often relying on generalized therapies or frequent intravenous treatments. We see a clear opportunity to improve upon that with alvelestat. Mereo has built a strong foundation for this asset, making them an ideal partner as we collaborate during the option period to prepare for the next phase of development.”

“We are very pleased to have the opportunity to partner with Sentynl to advance alvelestat for patients with AATD-LD. We have been preparing alvelestat for a global Phase 3 study, backed by positive efficacy data from two Phase 2 studies. 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, the company would also receive up to $40 million in upfront and R&D payments until NDA filing. Under the terms, Mereo would also be eligible to receive double-digit tiered royalties on US net sales of alvelestat.

Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. During the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design.