Sentynl Therapeutics and Mereo BioPharma have announced that they have entered into an option and license 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 US.

The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialise alvelestat for AATD-LD in the US, 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.

Dr. Sharvil P Patel, Managing Director (MD), Zydus Lifesciences, said, "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. 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."

Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the company would also receive up to USD 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 US 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.

Matt Heck, CEO, Sentynl Therapeutics, said, "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. For patients with AATD-LD, the current standard of care is demanding, often relying on generalised 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."