Avidity Biosciences, Inc.

Climate Impact & Sustainability Data (2022, 2023, 2024, 2024-03-04)

A serious adverse event reported in a single participant in the 4mg/kg cohort of the MARINA study led to a partial clinical hold on new participant enrollment by the FDA.

Avidity is working closely with the FDA and the trial investigator to resolve the partial clinical hold.

Surveyed 92 investigators and research staff from 36 clinical trial sites to understand efforts to increase diversity in muscular dystrophy clinical trials.
Identified 8 actions to promote diversity in clinical trials as mostly or very feasible by at least 80% of respondents.

Lack of diversity in clinical trials, resulting in treatments not tested on a significant portion of the population.
Variability in sites' knowledge and actions to ensure clinical trial participation matches the disease population.
Barriers to increasing diversity including non-inclusive trial design, limited access for specific populations, and lack of information about patient population demographics.
Historical and ongoing exploitation of BIPOC and underrepresented groups in research.

Survey to understand current practices and identify feasible actions.
Initiatives to address barriers such as waiving fees for translation software, providing translated materials, and hiring bilingual recruitment specialists.
Formation of a DEI committee to increase awareness and develop implementation plans.
Increased recruitment and inclusion of all patients in disease-specific databases.

Partial clinical hold related to AOC 1001, potentially causing delays and additional expenses.
Potential for inconsistent participant data and differing conclusions from further analysis.
Risk of unexpected adverse side effects or inadequate efficacy, leading to delays, limitations, or additional clinical holds.