Community Communications
June 2024 – Delpacibart braxlosiran (AOC 1020) FORTITUDE™ Phase 1/2 Initial Data
May 2024 – FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC 1001)
March 2024 – Delpacibart Etedesiran (AOC 1001) MARINA-OLE™ Long-term Data and Phase 3 HARBOR Study
December 2023 – AOC 1044 Healthy Volunteer Data Update
October 2023 – AOC 1001 Data Update
Clinical Studies
The global Phase 3 HARBOR™ trial is a randomized, placebo-controlled, double-blind pivotal study designed to evaluate del-desiran in approximately 150 people (age 16 and older) living with DM1. The trial will be conducted at approximately 40 sites globally. For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT06411288.
MARINA-OLE™ is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of del-desiran in participants with DM1 who were previously enrolled in the MARINA® Phase 1/2 trial. For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT05479981.
The FORTITUDE™ trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial designed to evaluate single and multiple doses of del-brax (AOC 1020) in 39 adult participants with facioscapulohumeral muscular dystrophy (FSHD). Avidity plans to initiate registrational cohorts in the FORTITUDETM study starting in the second half of this year. For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT05747924.
The EXPLORE44™ trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial to evaluate AOC 1044 in healthy volunteers and participants with DMD mutations amenable to exon 44 skipping (DMD44). For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT05670730.