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Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes

Provention Bio Initiates Phase 3 PROTECT Clinical Trial with PRV-031 (Teplizumab) in Patients with Recent Onset Type 1 Diabetes

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OLDWICK, N.J., April 9, 2019 /PRNewswire/ — Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has dosed the first patient in its Phase 3 PROTECT clinical trial of PRV-031 (teplizumab) in patients with recent onset type 1 diabetes (T1D).  PRV-031 (teplizumab) is an anti-CD3 monoclonal antibody in development for the interception of TID.  

“PRV-031 (teplizumab) has the potential to be the first ever disease modifying therapy in T1D, and the first drug class approved for T1D since the introduction of insulin,” said Dr. Kevan Herold, M.D., Professor of Immunobiology and Medicine at Yale University. “Data from prior clinical studies have indicated the potential of PRV-031 (teplizumab) to preserve functional beta cell mass, thereby conserving natural insulin production and reducing the need for insulin therapy.  PRV-031 (teplizumab) may therefore offer a much-needed improvement over currently approved treatment options for T1D.  I commend the patients, the Provention team, and my fellow clinicians for undertaking this study and look forward to further exploring its potential impact in newly-diagnosed T1D patients.”

The PROTECT study is designed to confirm the effect of PRV-031 (teplizumab) to slow the loss of insulin-producing beta cells and preserve beta cell function, as measured by C-peptide, in children and adolescents 8-17 years old who have been diagnosed with T1D in the previous six weeks and with pre-specified beta cell reserve at study entry.

“The initiation of the PROTECT study represents a significant milestone in our efforts to develop agents that intercept or prevent immune-mediated diseases,” stated Ashleigh Palmer, CEO of Provention Bio. “If successful, this pivotal Phase 3 trial could serve as the basis for a Biologics License Application (BLA) for PRV-031 (teplizumab), providing a therapeutic option that could transform the therapeutic landscape for T1D.”

PROTECT Phase 3 Trial

The global PROTECT (PROvention T1D trial Evaluating C-peptide with Teplizumab) Phase 3 clinical trial is a randomized, double‑blind, placebo-controlled, multicenter trial that is expected to enroll approximately 300 patients ages 8-17 with recent onset T1D at approximately 80 centers worldwide. The patients will be randomized 2:1 to either two 12-day cycles, six months apart, of intravenous PRV-031 (teplizumab) or placebo. The primary efficacy endpoint is C-peptide change. Secondary endpoints include insulin use, HbA1c, hypoglycemic episodes, and safety.  Provention expects to complete enrollment in the trial by the end of 2020.

Additional information is available at clinicaltrials.gov.

About PRV-031 (teplizumab)

PRV-031, also known as teplizumab, is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception of type 1 diabetes (T1D). Provention Bio acquired PRV-031 from MacroGenics, Inc. in May 2018.  The candidate has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving PRV-031 in those studies.  PRV-031 may also hold potential in the prevention or delay in onset of T1D and is currently being evaluated in the “At Risk” Study, a clinical trial conducted by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at TrialNet sites in relatives of T1D patients at risk for developing the disease.

About Provention Bio, Inc.

Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease.  Provention’s mission is to in-license, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn’s disease, ulcerative colitis, celiac disease, lupus, and certain life-threatening viral diseases. Provention’s diversified portfolio includes advanced-stage product development candidates that have undergone clinical testing by other companies. For more information on Provention Bio, please visit www.proventionbio.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Provention’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; our need for additional financing and the risks listed under “Risk factors” in our annual report on Form 10-K for the year ended December 31, 2018 and any subsequent filings with the Securities and Exchange Commission (SEC). As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.

SOURCE Provention Bio, Inc.

Posted: April 2019

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