Sentynl Therapeutics and Mereo BioPharma Announce Option and License Agreement for alvelestat in AATD-LD

Sentynl Therapeutics and Mereo BioPharma Announce Option and License Agreement for alvelestat in AATD-LD​

Sentynl Therapeutics, Zydus Lifesciences Limited, and Mereo BioPharma Group plc have announced an option and license agreement concerning alvelestat, a novel neutrophil elastase inhibitor being developed for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD). This partnership grants Sentynl the exclusive right to commercialize alvelestat in the United States, while Mereo retains global development leadership and commercial rights for the rest of the world.

Alvelestat is a small molecule intended as a potential first oral treatment for AATD-LD, a rare genetic respiratory disease estimated to affect 50,000 to 80,000 individuals in the United States.

Key Details of the Collaboration​

The agreement outlines the commercial and development rights for alvelestat. Under the terms:

• U.S. Market: Sentynl Therapeutics holds the exclusive right to acquire a license to commercialize alvelestat for AATD-LD in the United States.
• Global Rights: Mereo BioPharma retains commercial rights and leads the global development of the drug.
• Manufacturing: Sentynl has granted global manufacturing rights for alvelestat for AATD-LD.
• Financial Terms: Mereo will receive a non-refundable option fee from Sentynl. Upon option exercise, the company is eligible to receive up to $40 million in upfront and R&D payments until NDA filing. Furthermore, Mereo is qualified to receive double-digit tiered royalties on U.S. net sales of alvelestat.

The companies plan to collaborate during the short option period, which includes refining the Phase 3 study design for alvelestat, which could be initiated in early 2027.

Background on Alvelestat and AATD-LD​

Alvelestat is described as a novel oral small molecule designed to inhibit neutrophil elastase (NE). This enzyme is implicated in inflammation and lung tissue destruction. As a small molecule, alvelestat can penetrate lung tissue and access both cell-bound and soluble elastase.

The safety and tolerability of alvelestat have been established through clinical trials involving over 1,000 patients suffering from respiratory diseases, including AATD-LD, COPD, bronchiectasis, cystic fibrosis, COVID-19, and bronchiolitis obliterans syndrome following allogeneic stem cell transplant.

Alvelestat holds Orphan Drug Designation for AATD-LD from the FDA and the European Commission, and it has received Fast Track designation from the FDA.

Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD) is a rare genetic condition resulting from an alpha-1 antitrypsin deficiency. This lack of protein protection against damaging enzymes released during inflammation can lead to pulmonary emphysema, a progressive lung disease characterized by severe shortness of breath, chronic cough, and sputum production. Individuals with AATD may also experience asthma and bronchiectasis.

Company Insights​

Dr. Sharvil P. Patel, Managing Director at Zydus Lifesciences Limited, stated that the partnership represented a pivotal moment for Sentynl’s rare disease strategy, viewing alvelestat as a promising candidate capable of addressing an area of significant unmet need.

Matt Heck, CEO of Sentynl Therapeutics, commented on the opportunity to improve upon the current standard of care for AATD-LD, which often involves generalized therapies or frequent intravenous treatments. Denise Scots-Knight, CEO of Mereo BioPharma, expressed satisfaction at partnering with Sentynl to advance alvelestat, noting that Mereo has been preparing alvelestat for a global Phase 3 study, supported by positive efficacy data from two Phase 2 studies.

Mereo BioPharma is focused on rare diseases and holds three product candidates: setrusumab (for osteogenesis imperfecta), alvelestat (for AATD-LD), and vantictumab (for autosomal dominant osteopetrosis type 2, ADO2). Sentynl Therapeutics, a U.S.-based biopharmaceutical company, focuses on bringing innovative therapies to patients with rare diseases through its global operations in collaboration with Zydus Lifesciences Limited.

ZYDUSLIFE Stock Price Movement​

Today, shares of Zydus Lifesciences Limited surged to close at ₹1191 after gaining 6.43%, underscoring a strong day in the pharmaceutical sector. The stock’s impressive climb was highlighted as it reached its 52-week high, with a volume of 8.19 million shares trading today.