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Msg  36695 of 37263  at  3/3/2021 4:11:41 PM  by


PRVB- Publication of Extended Follow-up Data

Provention Bio Announces Publication of Extended Follow-up Data from the Pivotal "At-Risk" TN-10 Study of Teplizumab in Science Translational Medicine
-One course of teplizumab delayed insulin dependence by approximately three years and improved beta cell function in at-risk (Stage 2) type 1 diabetes patients-

PR Newswire

RED BANK, N.J., March 3, 2021

RED BANK, N.J., March 3, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that extended follow-up data from the pivotal "At-Risk" TN-10 Study were published in Science Translational Medicine. Results show that a single 14-day infusion course of teplizumab (PRV-031) delayed the onset of clinical disease and insulin dependence in at-risk type 1 diabetes (T1D) patients by approximately three years (median of 32.5 months), adding one year to previously reported results. The TN-10 Study was conducted through the Type 1 Diabetes TrialNet, an international research collaboration aimed at discovering ways to delay or prevent type 1 diabetes.

(PRNewsfoto/Provention Bio, Inc.)

Teplizumab, Provention's lead drug candidate, is an anti-CD3 monoclonal antibody currently under review by the U.S. Food and Drug Administration (FDA) for the delay or prevention of clinical T1D in at-risk individuals, defined as having two or more T1D-related autoantibodies and dysglycemia (Stage 2 T1D). The lifetime risk of insulin-dependent clinical disease (Stage 3 T1D) approaches 100% in these pre-symptomatic Stage 2 patients.

"Teplizumab is the first disease-modifying investigational drug with data showing an ongoing delay to insulin-dependent T1D, now by approximately three years after a single course," said Dr. Kevan Herold, M.D., Professor of Immunology and Medicine at Yale University, lead author of the study. "These data build on existing clinical evidence demonstrating the potential for teplizumab to change the course of the disease and advance the treatment paradigm. We are continuing to observe patients in the TN-10 Study to determine whether the observed delay will extend even further over time."

The median time to clinical T1D was approximately 5 years in teplizumab-treated patients compared to slightly over 2 years in the placebo group. At this median follow-up of 2.5 years, twice as many teplizumab-treated patients remained free of clinical T1D compared to patients in the placebo group, 50% vs 22% respectively, (HR=0.457 p=0.01).

"It is very encouraging to see that a single course of teplizumab delayed insulin dependence in this high risk population for approximately three years versus placebo," said Frank Martin, Ph.D., JDRF Director of Research. "These exciting results have been made possible by the unwavering efforts of TrialNet and Provention Bio. Teplizumab, if approved by the FDA, could positively change the course of disease development for people at risk of developing T1D and their standard of care."

The following includes key additional data and analysis from the publication:

    Teplizumab treatment improved beta cell function, with an average on-study C-peptide AUC of 1.96 vs 1.68 pmol/ml, p=0.006.
    Initiation of teplizumab treatment reversed the decline in C-peptide levels while controls continued to decline (p=0.0015). The changes in C-peptide with teplizumab treatment were associated with increases in partially exhausted memory KLRG1+ TIGIT+ CD8+ T cells (r=0.44; p=0.014) that showed reduced secretion of IFN-gamma and TNF-alpha.
    Total and early insulin secretory capacity was improved with teplizumab treatment suggesting improvement in beta cell glucose sensitivity reflecting normal beta cell function.
    Teplizumab was well tolerated, and the safety data is consistent with previous analyses.

"These data embolden our enthusiasm surrounding the potential impact teplizumab may have on the lives of T1D patients, families and caregivers," said Ashleigh Palmer, CEO and Co-Founder, Provention Bio. "Outcomes such as these validate Provention's mission to intercept and prevent debilitating and life-threatening diseases.  We continue working closely with the FDA in their review of our BLA submission for teplizumab. The PDUFA goal date is July 2, 2021."

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