Histogenics historically focused on the development of restorative cell therapies, including its product candidate, NeoCart, which is an innovative cell therapy that utilizes various aspects of Histogenicsâ restorative cell therapy platform to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In the third quarter of 2018, Histogenics announced that its Phase 3 clinical trial of NeoCart did not meet the primary endpoint of a statistically significant improvement in pain and function in a dual threshold responder analysis one year after treatment as compared to microfracture. Based on the totality of the data, Histogenics initiated a dialogue with the FDA in the third quarter of 2018 to discuss the regulatory path forward for NeoCart. Histogenicsâ primary objective in these discussions was to determine whether the FDA would accept a submission of a BLA for NeoCart without data from an additional clinical trial. Histogenics had a constructive dialogue with the FDA, which included requests for, and review of, additional statistical analyses, different subgroup analyses, and secondary endpoints. These additional analyses did not change the conclusion that the NeoCart Phase 3 trial failed to meet its primary and secondary endpoints.
Source
