Sentynl Therapeutics, a US-based biopharmaceutical company and subsidiary of Zydus Lifesciences, and Mereo BioPharma Group have entered into an option and licence agreement covering the US commercial and global manufacturing rights to alvelestat for alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD).

Alvelestat is a neutrophil elastase inhibitor being prepared for Phase III development. If approved, it could become the first oral treatment for AATD-LD, a rare and progressive genetic lung disease estimated to affect 50,000–80,000 people in the US.

Under the agreement, Sentynl has the exclusive option to obtain a licence to commercialise alvelestat in the US, while Mereo will retain commercial rights in other markets. Sentynl will also receive global manufacturing rights for the treatment.

If the option is exercised, the agreement will provide funding for the Phase III development programme, which could begin in early 2027. Mereo will lead the global Phase III trial and regulatory activities until the study is completed, while both companies will work together during the option period on manufacturing and the development of the Phase III study design.

The agreement follows positive efficacy results from two Phase II studies supporting the further development of alvelestat.

Mereo will receive a non-refundable option fee from Sentynl and could receive up to $40 million in upfront and research and development payments through to the filing of a New Drug Application (NDA). Mereo will also be eligible for double-digit tiered royalties on US net sales of alvelestat.

AATD is a rare genetic condition that causes low levels of alpha-1 antitrypsin, a protein that helps protect the lungs from damage. Severe deficiency can lead to pulmonary emphysema and other progressive lung conditions, resulting in symptoms such as breathlessness, chronic cough and recurrent exacerbations.

The agreement strengthens Sentynl’s rare disease portfolio and supports Mereo’s plans to advance alvelestat towards Phase III development.

 

Source: prnewswire.com

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