RED BANK, NJ, April 27, 2021 / PRNewswire / – Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company devoted to catching and preventing immune-mediated diseases, announced today that it will be attending an informal meeting with the US Food and Drug Administration (FDA) participated. on April 23, 2021in connection with the FDA’s ongoing review of the Teplizumab Biologic License Application (BLA) to delay or prevent clinical type 1 diabetes (T1D). The aim of this meeting was to discuss the FDA’s previous deliberations on the comparability of the company’s proposed commercial product and the drug used in the past in clinical trials derived from a drug substance manufactured by Eli Lilly over a decade ago.
The FDA reported at the meeting that it had concluded that the pharmacokinetic (PK) profiles of the two drugs, as assessed in the company’s low-dose pharmacokinetic / pharmacodynamic (PK / PD) bridging study conducted in healthy volunteers, have since been evaluated are not comparable The intended commercial product did not meet the specified PK area of 80-125% below the comparative target area of the curve (AUC). The FDA also stated that it cannot be certain that this observation is not clinically relevant, as the relationship between transient lymphocyte reduction, a PD marker that was comparable in the PK / PD bridging study, and clinical efficacy is still ongoing is not fully confirmed.
The FDA emphasized its understanding of the high unmet need associated with delaying the onset of T1D in the clinical stage and reiterated its willingness to work with the company to find a solution and a pathway to the comparability problem. Still, the company reiterates previous guidance that the FDA’s PK comparability considerations are likely to delay potential BLA approval deadlines, and that the details of that delay will depend on the outcome of ongoing discussions with the FDA to find a solution, including potential FDA reviewers PK / PD data from the company’s ongoing Phase 3 PROTECT trial in newly diagnosed patients.
The FDA also announced that it intends to include its PK comparability test in the clinical pharmacology summary of its briefing materials for the advisory committee meeting on May 27thAlong with a statement that the FDA is actively working with the company to resolve the issue and that the advisory committee meeting will focus on the efficacy and safety of teplizumab. The Company believes that no comparable questions or topics for discussion are planned for the meeting because the FDA’s PK comparability considerations have no impact on the risk-benefit assessment of the clinical data package of the TN-10 study. The FDA also recommended that both the FDA and the Company update their Advisory Committee materials to reflect the deletion of the term “prevention” from the previously proposed indication, as the remaining term “delay” more accurately reflects the results of the TN-10 Attempt.
“We would like to thank the FDA for meeting with us to explain their PK comparability considerations so far, and especially for their willingness to work with us to find a way forward,” she said Ashleigh Palmer, CEO and co-founder of Provention Bio. “We also fully agree with the FDA’s recommendation to remove the term ‘prevention’ from the wording of the original indication of teplizumab and instead focus solely on delaying the progression of the disease. We believe this will help will reinforce the fact that while this is presymptomatic, T1D patients with dual autoantibodies and dysglycemia already have the disease and can benefit from therapeutic options aimed at maintaining functional beta cell mass. We remain excited with the data On the clinical efficacy and safety presented in the context of the BLA in support of the treatment potential of teplizumab We look forward to joining the patient community, treating physicians and other members of the T1D community at the upcoming FDA Advisory Committee meeting participate, whose B The meaning could not be greater at this point. “
About teplizumab (PRV-031):
Teplizumab is an anti-CD3-anti-CD3 monoclonal antibody (mAb) with a BLA submitted by the FDA under Priority Review to delay or prevent clinical type 1 diabetes (T1D) in people at risk. More than 800 patients have received teplizumab in multiple clinical trials with more than 1,000 subjects. In previous studies in newly diagnosed patients, teplizumab consistently demonstrated the ability to maintain beta cell function, a measure of endogenous insulin production. The need for exogenous insulin consumption has been reduced accordingly. Teplizumab has been recognized as Breakthrough Therapy by the FDA and PRIME by the European Medicines Administration. The prevention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (phase 3 PROTECT study).
About Provention Bio, Inc .:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of research therapies that can target and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab, its leading investigational drug candidate, to delay or prevent clinical type 1 diabetes in people at risk, has been submitted by the US Food and Drug Administration (FDA). The company’s pipeline includes additional clinical-stage product candidates that have demonstrated the mechanism and / or the concept in other autoimmune diseases, including celiac disease and lupus, in preclinical or clinical studies. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.
Internet publication of information:
Provention Bio, Inc. uses its website www.proventionbio.com as a means of disclosing material non-public information and complying with its disclosure requirements under Regulation FD. This information will be posted on the company’s website in the “News” section. Accordingly, investors should monitor and follow this portion of the company’s website in addition to its press releases, SEC filings, and public conference calls and webcasts.
Forward-looking statements:
Certain statements in this press release are forward-looking, including, but not limited to, statements regarding the regulatory review of the BLA filing for teplizumab and the possible approval of teplizumab, including a delay in relation to these, the possible therapeutic effects and safety of teplizumab and the FDA willingness to work with us to resolve the teplizumab comparability problem between our proposed commercial product and the drug used in the past in clinical trials derived from drug substances manufactured by Eli Lilly, including potential supply of PK / PD data by FDA reviewers, the ongoing phase 3 PROTECT study in newly diagnosed patients. These statements can be identified by the use of forward-looking words such as “anticipate”, “believe”, “project”, “estimate”, “expect” and “intend”. These forward-looking statements are based on the company’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 expressed in such forward-looking statements. These factors include, but are not limited to, risks associated with delay or failure to obtain FDA approvals for teplizumab or any of the Company’s product candidates, and the potential for non-compliance with FDA regulations; the inability to work successfully with the FDA to find a satisfactory solution to address their concerns in a timely manner or at all, including the inability to use the FDA PK / PD data from our ongoing Phase 3 PROTECT trial or any other adequate data To provide approval from the BLA to support teplizumab; the potential impact of COVID-19 on our business and financial results; Changes in law, regulation, or interpretation and enforcement of policies; Uncertainties regarding patent protection and litigation; the company’s dependence on third parties; significant competition; the company’s need for additional funding and the risks set out under “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2020, and any subsequent filings with the Securities and Exchange Commission. As with any drug in development, there are significant risks associated with the development, regulatory approval and commercialization of new products. Provention undertakes no obligation to update or revise any forward-looking statements as a result of new information, future developments or for any other reason, unless this is required by law. The information contained herein is only valid as of the date of this Agreement.
Investor contacts:
Robert Doody, VP of Investor Relations
[email protected]
484-639-7235
Sam Martin, Argot Partners
[email protected]
212-600-1902
Media contact:
Lori Rosen, LDR Communications
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917-553-6808
SOURCE Provention Bio, Inc.
