Under the agreement, Sentynl will have the exclusive option to acquire a licence to commercialise alvelestat for AATD-LD in the US, while Mereo will retain commercial rights in the rest of the world. Sentynl will also receive global manufacturing rights for the drug.
Alvelestat is an oral neutrophil elastase inhibitor being prepared for Phase 3 development. If approved, it could become the first oral treatment for AATD-LD, which is estimated to affect between 50,000 and 80,000 people in the US.
The companies expect the Phase 3 development programme could begin in early 2027.
Mereo will receive a non-refundable option fee from Sentynl. If Sentynl exercises the option, Mereo will be eligible to receive up to $40 million in upfront and research-and-development payments through the filing of a New Drug Application, as well as 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 work together to refine the Phase 3 study design and advance manufacturing activities.Alvelestat has received Orphan Drug Designation for AATD-LD from both the US Food and Drug Administration and the European Commission. It has also received Fast Track designation from the FDA.
Zydus Lifesciences shares closed 6.43% higher at ₹1,191 on the NSE on Tuesday.
