Stages of Development for Astellas ASP2016

The drug development process can be thought of as a series of stages, and successful drugs must pass through each stage to become available to patients.

Link to Astellas Gene Therapies

AT808, the gene therapy candidate obtained as part of its $3 billion acquisition of Audentes never made it through the preclinical stage. Astellas is dividing it into two separate programs to target two different aspects of Friedreich’s ataxia. ASP2016 is the first targeting cardiac aspects of FA.

Preclinical safety and efficacy studies supported clinical development of ASP2016.

April 2024: Astellas announced the FDA has cleared its IND for ASP2016 in April 2024. The company is hoping to dose the first patient in the second half of 2024, according to Richard Wilson, who leads genetic regulation at Astellas Gene Therapies.

News and Press Releases

| Apr 25, 2024

Astellas shares that US FDA cleared their IND with Fast Track designation for Phase 1 trial of their investigational gene therapy for the treatment of cardiomyopathy in FA

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