Histogenics has released positive Phase 2 data for NeoCart Autologous Cartilage Tissue Implant (ACTI) to treat knee cartilage injury.
NeoCart is a bio-engineered neo-cartilage implant that contains an autologous chondrocyte population which is matured in a biodegradable collagen matrix.
The study is a controlled, perspective, randomized which is designed to assess improvements in knee and general health outcomes scores by comparing NeoCart to microfracture (MF).
Efficacy outcomes are measured by using Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) Score.
The data showed outcome scores by six months, at the primary endpoint of twelve months, and that are then sustained for at least two years.
NeoCart had a higher proportion of therapeutic responders in comparison to MF at one and two years with improvements in knee function, pain (including maximum pain), activities of daily living, and sport and knee quality of life.
In addition, the study confirmed a favorable safety profile for NeoCart.
Histogenics president and CEO Patrick Donnell said building on these results, Histogenics has advanced this program into a Phase 3 trial under a Special Protocol Assessment (SPA) with the FDA.