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Provention Bio Announces Top-Line Results from its Phase 1b PULSE Clinical Trial of PRV-300 in Patients with Moderate-to-Severe Ulcerative Colitis
OLDWICK, N.J., May 8, 2019 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced preliminary top-line results from its Phase 1b PULSE study which evaluated PRV-300, an anti-TLR3 (toll-like receptor 3) monoclonal antibody, in patients with active, moderate-to-severe ulcerative colitis (UC).
PRV-300 met the primary safety and tolerability endpoint over the twelve-week study period and also demonstrated TLR3 target engagement and proof-of-mechanism. However, improvements in secondary and exploratory clinical, endoscopic, histologic and other UC-related efficacy endpoints were not observed over background medication, suggesting that elevated TLR3 gene signatures previously observed in UC patients, as well as in PULSE, are downstream or circumstantial effects that do not contribute significantly to causal pathology.
"I would like to thank the PULSE study patients, coordinators and investigators, as well as Provention's expert clinical development team, for their time, efforts, and dedication in conducting such a definitive, cost-effective, and efficient clinical trial," said Ashleigh Palmer, CEO of Provention Bio. "The PULSE study, which enrolled 37 patients at three sites in just seven months, exemplifies how Provention can rapidly determine go/no-go decisions regarding the further development of therapeutic candidates with the potential to intercept immune-mediated diseases. PRV-300 did not demonstrate an upstream effect on clinically relevant parameters in UC, but its favorable safety and tolerability profile, and demonstration of proof-of-mechanism, may offer an opportunity to sub-license this asset for evaluation in other indications, including severe influenza and emerging viral diseases, where an anti-TLR3 antibody has been successful in preventing the release of toxic inflammatory mediators in animal models."
The Phase 1b PULSE (Provention ULcerative colitis Safety/PK/PD Evaluation) clinical trial was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study that evaluated PRV-300 in 28 active, and 9 placebo, adult patients with moderate-to-severe ulcerative colitis. All patients enrolled were naïve to other biologics and received PRV-300 treatment intravenous infusion over 12-weeks followed by an 8-week safety follow-up period. The primary endpoint of PULSE was to evaluate the safety and tolerability of PRV-300. Secondary endpoints measured included PK and immunogenicity, mucosal healing, tissue improvement and a biopsy-based mucosal mRNA signature. Secondary and exploratory endpoints showed improvement in clinical, endoscopic, histologic and gene disease scores at week 12 vs baseline; however, these improvements were similar in both active and placebo arms.
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, 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.
David Rosen, Argot Partners
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