The FOXG1 Research Foundation has named Brandon M. Henry, M.D., as Chief Medical Officer as FRF-001 advances toward a first-in-human clinical trial. Dr. Henry brings deep experience in AAV gene therapy development and will lead clinical strategy and oversight as we prepare to move into patient clinical trials.

The FOXG1 Research Foundation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FRF-001 for the treatment of FOXG1 syndrome — marking another major regulatory milestone as we advance toward our first-in-human Phase 1/2 clinical trial.

The FOXG1 Research Foundation announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin first-in-human clinical trials for FRF-001, the first FOXG1 AAV9 gene replacement therapy.

WILMINGTON, Mass.--(BUSINESS WIRE)--Jul. 30, 2024-- Charles River Laboratories International, Inc. (NYSE: CRL) announced today a collaboration with the FOXG1 Research Foundation (FRF) highlighting the patient advocacy group’s model to independently drive drug development through the clinical phase. The parent-led global organization driving the research to cure FOXG1 syndrome and related neurological disorders will collaborate with Charles River in a comprehensive gene therapy contract development and manufacturing organization (CDMO) agreement.

“Charles River is proud to work with the FOXG1 Research Foundation to advance its gene-therapy through clinical trials,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “The FOXG1 patient population has an incredible unmet need, and we are looking forward to lending our expertise to FRF as they continue to trailblaze a path toward providing rare disease treatments.