Histogen was verbally notified about additional questions from FDA for the company’s Investigational New Drug (IND) application package for the planned Phase I/II clinical trial of HST-003. The trial is evaluating the human extracellular matrix (hECM:HST-003) implanted within microfracture interstices and a knee cartilage defect to regenerate hyaline cartilage in combination with microfracture.
FDA expects to provide written notice by February 12, 2021. They indicated that the clinical hold is due to pending chemistry, manufacturing and controls information required to complete their review. Histogen plans to work diligently with FDA to pursue release of the clinical hold and provide updated guidance on any potential impact to the HST-003 program once the written notice from FDA is received.
The IND application with FDA was submitted at the close of 2020.
Histogen’s hECM is intended for hyaline cartilage regeneration for the treatment of articular cartilage defects using a malleable scaffold that stimulates the body’s own stem cells. In preclinical models, HST-003 has been shown to regenerate mature cartilage and well-vascularized bone, indicating therapeutic potential in sports medicine, spinal disc repair and orthopedic applications.