In the latest biotech stock news, Pfizer Inc. (NYSE:PFE) reported that in association with Celltrion Healthcare, the company released new report for inflectra at the 12th Congress of the ECCO. The report demonstrated that for subjects with Crohn’s disease, treatment with INFLECTRA has similar safety and efficacy to cure with REMICADE.
The randomized 54-week clinical trial in 214 subjects met its primary objective demonstrating that, at 6-weeks, INFLECTRA was comparable to REMICADE,1 in the cure of CD thereby achieving the criterion for non-inferiority. The study assessed the number of patients witnessing a decline of 70 points or greater in the CDAI-70, a well-established evaluation of treatment response in CD.
Pfizer reported that the response rates, 75.2% for REMICADE,1 and 71.4% for INFLECTRA were not statistically considerably different. INFLECTRA is promoted as INFLECTRA in the United States and under other brands in some nations.
Sam Azoulay, M.D., SVP, Chief Medical Officer of Pfizer Essential Health, reported that presentation of randomized control study data in subjects with Crohn’s disease further boosts the current clinical profile of ‘CT-P13’ in inflammatory bowel disease. Along with current report from the registration trials, real-world experience and the ‘NOR-SWITCH’ study, this report adds to the evidence supporting usage of CT-P13 across its permitted indications.
Additional disease activity initiatives used in the study, CDAI-100 and clinical remission response rates, showed consistent and similar efficacy between the 2 treatments. Six-week report also demonstrated that INFLECTRA had a similar tolerability and safety profile as REMICADE. The count of subjects witnessing at least one adverse event, grave adverse events, and harmful events of special interest were similar between the 2 treatment arms. No fresh safety signals were known.
Further report on the longer-term efficacy and safety of INFLECTRA from this current 54-week trial in CD from the leading biotech stock is anticipated later this year. The trial is also examining the safety profile and treatment response in patients when moved from INFLECTRA to REMICADE, and from REMICADE to INFLECTRA.