FDA grants Fast Track Designation to TxCell’s Ovasave for treatment of Crohn’s disease

TxCell’s lead product designated for the treatment of moderate to severe Crohn’s disease

TxCell SA (Euronext Paris: FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announces today that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to TxCell’s lead product Ovasave(R) for the treatment of moderate to severe Crohn’s disease. Ovasave already has an active IND (Investigational New Drug) with the FDA.

The FDA Fast Track program aims to facilitate the development and review of new drugs intended to treat serious or life-threatening conditions that have already demonstrated the potential to address unmet medical needs. The granting of Fast Track Designation will enable TxCell to work more closely with the FDA with the intent to accelerate the drug development program through to approval in order to make relevant medications available to patients sooner.

“The granting of Fast Track Designation by the FDA to TxCell’s Ovasave is in part due to the strong unmet medical need experienced by patients with moderate to severe Crohn’s disease. This FTD is also a sign of confidence from the FDA in the potential of Ovasave to address that need,” stated Miguel Forte, MD, PhD, Chief Operating Officer of TxCell. “In addition to the recent opening of the IND, this Fast Track status will help us to facilitate the timely development of Ovasave as a high priority program for TxCell and a significant potential opportunity for the treatment of refractory Crohn’s disease patients with no other option.”

Ovasave is an antigen specific autologous T regulatory somatic cell therapy in development for the treatment of Inflammatory Bowel Disease. Ovasave is currently in a randomised controlled phase IIb study entitled CATS29. The study aims to confirm the benefit of Ovasave for the treatment of patients with refractory Crohn’s disease. The CATS29 study follows an initial phase IIa study entitled CATS1.