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

MREO
  • Mereo BioPharma and Sentynl Therapeutics entered an option and license agreement granting Sentynl the right to commercialize alvelestat for AATD-LD in the United States.
  • Mereo retains commercial rights for the rest of the world & will lead global development of the Phase 3 study.
  • Sentynl holds global manufacturing rights for alvelestat & will have the option to exercise the license in the U.S.
  • Mereo receives an upfront option fee & is eligible for $40 million in upfront & R&D payments upon option exercise.
  • Mereo may receive up to $435 million in potential regulatory & commercial milestones & double-digit tiered royalties on U.S. net sales.
  • The Phase 3 study design is being refined collaboratively during the option period & the study could initiate in early 2027.
  • Alvelestat is a first-in-class oral neutrophil elastase inhibitor being developed for the rare genetic respiratory disease AATD-LD.
  • The treatment targets an estimated 50,000 to 80,000 individuals in the United States with AATD-LD.
  • Alvelestat has received Orphan Drug Designation from the European Commission & the FDA, plus Fast Track designation from the FDA.
  • Clinical data from over 1,000 patients supports the safety & tolerability profile of alvelestat for various respiratory diseases.
  • Sentynl is a U.S.-based subsidiary of Zydus Lifesciences Limited, focusing on expanding its rare disease portfolio.