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Sentynl Therapeutics and Mereo BioPharma Announce Option and License Agreement for alvelestat in Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD)

MREO
  • Sentynl Therapeutics & Mereo BioPharma entered an option & license agreement for alvelestat, a potential first-in-class oral treatment for AATD-LD.
  • Sentynl holds exclusive rights to acquire U.S. commercialization rights & global manufacturing rights for alvelestat upon option exercise.
  • Mereo retains commercial rights for the rest of the world & will lead the global Phase 3 development program & regulatory interactions.
  • Mereo will receive an upfront option fee & is eligible for up to $40 million in upfront & R&D payments until NDA filing if the option is exercised.
  • Mereo is also eligible for double-digit tiered royalties on U.S. net sales of alvelestat.
  • The companies will collaborate during the option period to refine the Phase 3 study design & streamline manufacturing.
  • Alvelestat is a neutrophil elastase inhibitor currently readied for Phase 3, with potential initiation in early 2027.
  • The treatment targets AATD-LD, affecting an estimated 50,000-80,000 individuals in the United States.
  • Alvelestat has received Orphan Drug Designation from the European Commission & FDA, plus Fast Track designation from the FDA.
  • Sentynl is a wholly-owned subsidiary of Zydus Lifesciences Limited.