The Critical Path Institute (C-Path) and Provention Bio, Inc. are proud to announce their collaboration to significantly improve the scientific community's insight into type 1 diabetes (T1D) through Provention's contribution of data from the Phase III Protégé study of teplizumab to the T1D Trial Outcome Measures Initiative (TOMI) integrated database. The Protégé study evaluated teplizumab on the preservation of beta cell function in newly onset T1D patients and generated the largest disease modifying interventional clinical trial dataset in T1D with more than 500 patients.
TOMI is an international partnership between academia, the pharmaceutical industry and nonprofit organizations funded by a grant from the world's leading charities dedicated to diabetes research, JDRF and Diabetes UK. The primary goal of the TOMI is to seek the regulatory endorsement of drug development tools with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to accelerate the development of new therapies in T1D.
The Data Contribution Agreement (DCA) between Provention and C-Path will allow for this unique set of clinical trial data to be integrated and managed by C-Path's Data Collaboration Center (DCC) adding to the effort of developing advanced drug development tools including a clinical trial simulation tool (CTST) for regulatory approval. This CTST will help identify optimal clinical endpoints in future studies to improve clinical interpretability of trials, shorten the time to primary outcome and/or minimize the number of participants required in trials.
The Protégé data includes relevant information about disease progression, drug effects and clinical trial design. Contribution of these data is critical to TOMI's work in developing innovative and quantitative tools based on robust data that can be endorsed by regulators and be used in confidence by the pharmaceutical industry to optimize future clinical trial designs.
"C-Path is excited to facilitate the analysis of data with this esteemed group of T1D scientists," said C-Path's Executive Director of the T1D Consortium Inish O'Doherty, Ph.D. "Seeing the T1D community work together to solve challenging questions is encouraging and we are looking forward to the future of drug development in T1D."
We are proud to contribute such a large set of patient-level data from the Phase III Protégé study of teplizumab to the TOMI. This collaboration embodies our continued support to increase pre-competitive collaborations and to advance effective public-private partnerships in the field of T1D to accelerate drug development.”
Francisco Leon, M.D., Ph.D., Co-founder and Chief Scientific Officer of Provention Bio
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