ARTICLE | Clinical News

RG-101 regulatory update

August 15, 2016 7:00 AM UTC

Regulus said FDA issued a request for information related to the clinical hold on RG-101. The agency requested a detailed safety data analysis from preclinical and clinical trials; exploration of potential mechanisms of hepatotoxicity in non-clinical models; review and input from independent hepatotoxicity experts; additional pharmacokinetic data from a U.S. Phase I trial; and a risk/benefit assessment for the proposed therapeutic combinations containing RG-101. Regulus expects to submit the information to FDA by early 4Q16, with a decision from the agency within 30 days of receipt of the response. ...