Following a strategic evaluation of its regenerative medicine platform technology programs, Histogen announced plans to focus on high-value orthopedic indications for its human extracellular matrix and intradiscal injection products.
Histogen is on track to initiate a Phase I/II clinical study of HST 003 within the month, examining human extracellular matrix (hECM) implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage alongside microfracture.
HST 004 is a CCM solution administered through an intradiscal injection for spinal disc repair. Initial preclinical research demonstrated that HST 004 stimulates stem cells from the spinal disc to proliferate and secrete aggrecan and collagen II, regenerate normal matrix and cell tissue structure, and restore disc height. HST 004 was also shown to both reduce inflammation in an ex vivo spinal disc model. An Investigational New Drug application is slated for filing in 2H22.
Richard W. Pascoe, President and Chief Executive Officer, said, “As a result of our evaluation, we have charted a new course for Histogen with a focus on orthopedic indications that we believe sit at the crossroads of pre-clinical and clinical proof of concept, significant commercial opportunity, and unmet medical needs. Moreover, we believe that by developing products that are therapeutically synergistic, we can be more efficient with our resources and create a strategic pipeline of novel therapeutics that has the potential to create long-term value for the benefit of our shareholders.”