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Provention Bio Provides Update on the Status of Its Phase 3 PROTECT Study for the Treatment of Newly Diagnosed Type 1 Diabetes

- PROTECT Study Randomization to be Paused Temporarily in Response to the Ongoing Public Health Crisis

- Company Reaffirms it is on Schedule to Complete PRV-031 (teplizumab) Rolling BLA Submission for Prevention or Delay of T1D in At-risk Individuals

OLDWICK, N.J., March 16, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced a temporary pause in the randomization of patients with newly diagnosed type 1 diabetes (T1D) into its global Phase 3 PROTECT study of PRV-031 (teplizumab). This pause is being taken out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture in the collective global efforts to combat the COVID-19 pandemic. Patients currently undergoing study therapy will be allowed to complete their course, as recommended by the PROTECT study's Data Safety Monitoring Board, which was recently expanded to include infectious diseases expertise. The Company remains on track to complete its rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab for the prevention or delay of T1D in at-risk individuals in the fourth quarter of 2020.

(PRNewsfoto/Provention Bio, Inc.)

"Our decision to pause randomization of new patients into the PROTECT study follows COVID-19-related State of Emergency declarations in many countries where our study is taking place, including the United States," said Ashleigh Palmer, CEO of Provention Bio. "Our decision was not based on any study-related COVID-19 infections or other safety events, but rather a preponderance of caution relating to the ongoing pandemic, and our concern for the well-being of recently diagnosed T1D pediatric patients and their caregivers. The demands on medical institutions and their clinicians during this unprecedented global crisis were also a main consideration in this decision. For avoidance of any doubt, we believe teplizumab will prove to be a well-tolerated therapy with a favorable safety profile as evidenced by our database of more than 800 patients. We will continue to monitor the situation closely and will provide an updated timeline for the PROTECT study at a future date."

Provention remains on track to complete its rolling BLA submission for teplizumab in T1D patients at-risk of developing clinical stage disease in the fourth quarter of 2020. As Provention has stated previously, the critical path to completion of the rolling BLA submission will be the filing of the chemistry, manufacturing and controls (CMC) module. The Company continues to expect to proceed with three commercial scale process performance qualification (PPQ) batches this summer, supporting the CMC module and enabling the completion of the rolling BLA submission as planned. The Company has not experienced any interruption in its supply chain or manufacturing efforts at this time.

As of this date, none of the Company's other clinical and pre-clinical operations have been significantly impacted by the COVID-19 Public Health Crisis.

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 90 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. 

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 and prevention of type 1 diabetes (T1D).  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. Teplizumab has been shown to delay the onset of end-stage T1D in at-risk individuals with pre-symptomatic disease.  In previous studies of newly diagnosed patients, PRV-031 has consistently demonstrated the capability of preserving beta cell function and reducing the need for exogenous insulin usage. Teplizumab has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration.  Provention is currently evaluating PRV-031 in patients newly diagnosed with clinical T1D (the Phase 3 PROTECT Study).

About Provention Bio, Inc.


Provention Bio, Inc. (Nasdaq: PRVB) is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention's mission is to source, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune diseases. Provention's diversified portfolio includes PRV-031 (teplizumab), a pre-commercial-stage candidate that has been shown to delay the onset of end-stage type one diabetes (T1D) in at-risk individuals with pre-symptomatic disease.  Teplizumab has been granted Breakthrough Therapy designation from the U.S. Food and Drug Administration. The Company's portfolio includes additional clinical-stage product development candidates that have demonstrated proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.

Forward Looking Statements


Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the length of the temporary pause in the Phase 3 PROTECT study of PRV-031 and the timing of submission of the BLA. 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, 2019 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.

Investors:
Sam Martin, Argot Partners
sam@argotpartners.com   
212-600-1902

Media:
David Rosen, Argot Partners
david.rosen@argotpartners.com 
212-600-1902

Cision

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SOURCE Provention Bio, Inc.