Provention Bio Files Clinical Module for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals

Rhea-AI Summary

Provention Bio has submitted the clinical module of its Biologic License Application (BLA) for teplizumab (PRV-031) to the FDA, aimed at delaying or preventing clinical Type 1 Diabetes (T1D). This marks a crucial step in bringing this investigational treatment to at-risk individuals. Following the rolling submission strategy, the final modules are expected by Q4 2020. The antibody has shown promise in clinical trials, with over 800 patients treated, and is designated as a Breakthrough Therapy by the FDA. Provention is preparing for a potential commercial launch.

Positive

• Submission of the BLA clinical module for teplizumab represents a major advancement in regulatory efforts.
• Teplizumab has shown potential to delay or prevent T1D in at-risk patients through clinical studies.
• The drug has received Breakthrough Therapy Designation from the FDA, indicating its significant clinical potential.

Negative

• There is inherent risk in the regulatory approval process and potential delays in obtaining FDA clearance.
• Provention relies significantly on the successful commercialization of teplizumab to drive future revenue.

RED BANK, N.J., Sept. 30, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the submission of the clinical module of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031), an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals.

A rolling submission allows for completed modules of the BLA to be submitted to the FDA on an ongoing basis. Provention initiated the rolling submission with the filing of the non-clinical module in April 2020. The Company expects to submit the final modules including the chemistry, manufacturing and controls (CMC) module in Q4 2020. Once the complete BLA has been submitted, the FDA will have 60 days to review the submission to determine if it is complete. If deemed complete, the application will be considered acceptable for review and the FDA will set a PDUFA goal date.

"The filing of the BLA clinical module for teplizumab is a critical step in our efforts to deliver teplizumab to pre-symptomatic patients to delay or prevent insulin-dependent T1D," said Dr. Eleanor (Leni) Ramos, MD, CMO, Provention Bio. "I especially want to thank Dr. Sharon Rowland, our SVP and Head of Regulatory Affairs and the BLA clinical team who have worked tirelessly for many months to achieve this goal. We look forward to working closely with the FDA as we advance the regulatory process and we remain on track to complete the full BLA submission in Q4 2020. In addition, we continue to scale our organization in preparation for a potential commercial launch, and we are well-positioned to execute our strategy to bring this disease-modifying treatment to the T1D community as soon as possible."

About Teplizumab (PRV-031):

Teplizumab is an anti-CD3 monoclonal antibody (mAb) being developed for the interception, delay, or prevention of type 1 diabetes (T1D).  More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab has consistently demonstrated the ability to preserve beta-cell function, a measure of endogenous insulin production, and correspondingly reduce the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Administration. Provention Bio has initiated a rolling submission of the Biologic License Application for teplizumab for the delay or prevention of insulin-dependent T1D for use in presymptomatic patients and expects to complete the submission in Q4 2020.  Provention is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT Study).

About Provention Bio, Inc.:

Provention Bio, Inc. (Nasdaq: PRVB) is a 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 teplizumab, a clinical-stage candidate that has been shown in a clinical study to delay the onset of insulin-dependent type 1 diabetes (T1D) in at-risk patients during the presymptomatic phase of the disease as compared to placebo. The Company's portfolio includes additional clinical product development candidates that have demonstrated in pre-clinical or clinical studies 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, including but not limited to, statements relating to the Company's planned submissions and timelines for the rolling BLA submission for teplizumab and the potential health benefits of, and commercialization efforts for teplizumab. 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 delays in, or failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance;  uncertainties of patent protection and litigation; 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, our quarterly reports on form 10-Q, and any subsequent filings with the Securities and Exchange Commission. 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.

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

Media:
Lori Rosen, LDR Communications
lori@ldrcommunications.com
917-553-6808

View original content to download multimedia:http://www.prnewswire.com/news-releases/provention-bio-files-clinical-module-for-teplizumab-for-the-delay-or-prevention-of-clinical-type-1-diabetes-in-at-risk-individuals-301142279.html

SOURCE Provention Bio, Inc.

FAQ

What is the latest update on Provention Bio's teplizumab submission?

Provention Bio has submitted the clinical module of its BLA for teplizumab to the FDA.

What is the purpose of teplizumab?

Teplizumab is intended to delay or prevent clinical Type 1 Diabetes in at-risk individuals.

When does Provention Bio expect to complete the full BLA submission for teplizumab?

Provention Bio expects to complete the full BLA submission in Q4 2020.

How many patients have been treated with teplizumab?

More than 800 patients have received teplizumab in various clinical studies.

What designations has teplizumab received from regulatory bodies?

Teplizumab has received Breakthrough Therapy Designation from the FDA and PRIME designation from the European Medicines Agency.