Histogenics' NeoCart misses in Phase III for knee cartilage repair

Histogenics Corp. (NASDAQ:HSGX) said NeoCart missed the primary endpoint of improving pain and function at one year in a Phase III trial to repair knee cartilage damage. The company said the product narrowly missed the threshold for significance and that it plans to meet with FDA to discuss the data and a possible BLA submission. NeoCart is an autologous engineered neocartilage implant created outside the body using the patient's own cartilage cells integrated into a 3D collagen matrix.

In the open-label, North American trial's modified intent-to-treat (mITT) population (n=242), NeoCart improved pain and function at one year in 74.2% of patients vs. 62% of patients who underwent microfracture surgery (p=0.0714). The primary endpoint comprised a dual threshold responder analysis in which a responder was defined as achieving a ≥12-point improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore assessment and a ≥20-point improvement in the International Knee Documentation Committee (IKDC) subjective assessment...