Benzinga | Mar 15, 2021 08:08AM EDT

Histogen Announces Removal of Clinical Hold by FDA for HST-003 IND to Initiate a Phase 1/2 Trial for Knee Cartilage Regeneration

Histogen Inc. (NASDAQ:HSTO), today announced that the U.S. Food and Drug Administration ("FDA") has confirmed that the Company satisfactorily addressed all clinical hold questions and can proceed with initiation of the planned Phase 1/2 clinical trial of HST-003 to evaluate the safety and efficacy of human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. It is anticipated that clinical sites participating in the trial will include: OasisMD in San Diego, CA, The Steadman Clinic in Vail, CO and Walter Reed Medical Center in Bethesda, MD.

"We are pleased to have been able to provide the FDA with a comprehensive response resulting in the removal of the clinical hold so we can initiate development of this important potential treatment," said Richard W. Pascoe, Histogen's President and CEO. "We anticipate initiating the Phase 1/2 trial in the second quarter of 2021 utilizing funding provided by the $2M grant from the Department of Defense."