TxCell SA, a biotechnology company specializing in developing novel immunotherapies for severe chronic inflammatory and autoimmune diseases, has just announced the enrollment and dosing of the first patient in the Phase IIb clinical study of Ovasave®, indicated for the treatment of refractory Crohn’s disease. Ovasave® (ovalbumin-specific autologous Treg cells) is the company’s lead product for this form of inflammatory bowel disease, and is currently approved for study in 6 European countries, with preliminary results expected by the end of 2016 to early 2017.
Previously completed studies on Ovasave demonstrated a favorable tolerance profile and treatment response in 75 percent of patients, with 38 percent achieving remission after 5 weeks of treatment. The ongoing Phase IIb study, “CATS29” will be conducted in 32 study sites across Austria, Belgium, France, Germany, Italy and the United Kingdom, and aims to enroll 160 patients with severe refractory Crohn’s disease. CATS29 will be evaluating treatment response rate for one intravenous dose of 1.10(6) cells of Ovasave, compared to a placebo 6 weeks following treatment. Response rate will be measured according to a decrease of at least 100 points in the Crohn’s Disease Activity Index (CDAI).
“The CATS29 study is a multicentre, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection, 4 parallel groups study. It will evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn’s disease. Patients will receive, double-blinded, two intravenous (iv) injections 8 weeks apart of either 1.10(4), 1.10(6), or 1.10(7) cells of Ovasave or placebo. Patients will then receive either an open-label treatment with 2 additional iv injections of 1.10(6) cells of Ovasave or a safety follow-up with no injection. Finally, there will be an extended safety follow-up for all patients.”
Dr. Miguel Forte, the company’s Sr. Vice President of Clinical Development and Regulatory Affairs, is confident the findings from CATS29 will corroborate those from pilot study, CATS1, and serve as a stable foundation for the last stage of clinical development. He adds, “Ovasave’s targeted, multi-target, multi-mechanism activity together with the personalized nature of the product, offers the chance of real innovation for refractory Crohn’s disease patients who currently have no treatment options. There are currently over 100,000 such patients per year in Europe and in the US alone.”
Lead investigator Dr. Severine Vermeire, a Professor of Gastroenterology at the University Hospital Leuven, said there is an urgent need for more reliable solutions to refractory Crohn’s disease, and Ovasave may just be the key to improving the quality of life of thousands of patients. All of the participating clinical centers have expressed their eagerness to help facilitate CATS29.