Provention Bio Announces Initiation of the Phase 2a PREVAIL-2 Study of PRV-3279 (CD32B × CD79 Bispecific DART® Molecule) in Systemic Lupus Erythematosus (SLE)

RED BANK, N.J., Jan. 20, 2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the initiation of the Phase 2a PREVAIL-2 study (PRV-3279 EVAluation In Lupus- Phase 2). PRV-3279 is an investigational humanized bispecific DART molecule targeting the B-cell surface proteins CD32B and CD79B, which has the potential to intercept the pathophysiology of systemic lupus erythematosus (SLE) and other B cell-mediated autoimmune diseases, as well as to prevent the immunogenicity of biotherapeutic products such as gene therapy.

The PREVAIL-2 study is a Phase 2a proof-of-concept (POC) study in moderate-to-severe SLE patients induced into response with a short course of corticosteroids, and then monitored for relapse, after randomization to either PRV-3279 or placebo treatment. This design enables the withdrawal of most concomitant medications and clear POC evaluation. The study will be conducted in the US and Hong Kong. Screening has commenced in the US with the goal of identifying and enrolling approximately 100 patients to 6 monthly infusions of PRV-3279 or placebo, with primary efficacy readout at 24 weeks. PRV-3279 was well-tolerated in a prior single ascending dose Phase 1 study and a multiple ascending dose Phase 1b study, PREVAIL-1, establishing proof of mechanism with long-lasting inhibition of B cell function as shown by reduction in IgM production 8 weeks post last dose of PRV-3279. These results, together with observations that CD32B genetic variants are associated with SLE, and that PRV-3279 inhibits B cells isolated from SLE patients, support evaluation in SLE.

"PRV-3279 offers an elegant mechanism of action designed to intercept and ameliorate the overactive B cell-driven pathology of lupus and other autoimmune diseases," stated Francisco Leon, MD PhD, Co-founder and Chief Scientific Officer of Provention Bio. "We believe that PRV-3279 allows for rapid inhibition of activated B cells, while sparing non-activated B cells from depletion or inactivation, which may offer the potential for an alternative to current B cell-targeting therapies with a more favorable safety profile. We look forward to reporting data from PREVAIL-2 in the first half of 2024."

"PRV-3279 brings together two relevant immune protein targets to strategically modify their interactions. CD79B is part of the B cell receptor and CD32B is a natural regulator of B cells," said Joan Merrill, MD, Director of Clinical Projects, Arthritis and Clinical Immunology Program at Oklahoma Medical Research Foundation, who has led international efforts to develop more interpretable trials. "Stratification and pre-defined subset analysis in PREVAIL-2 of a potentially highly responsive SLE population using a B cell gene signature may identify patients most likely to benefit from PRV-3279 therapy in the future."

About Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can cause inflammation and pain throughout the body. A person with SLE might experience joint pain, skin sensitivities, and rashes, and issues with internal organs (brain, lungs, kidneys, and heart). The exact cause of SLE isn't known, but several factors are associated with the disease, including genetics, environment, sex, and hormones. The current goal of treatment for SLE is to ease symptoms and minimize organ damage. No cure for SLE exists.

About PRV-3279

PRV-3279 is an investigational humanized bispecific DART molecule targeting the B-cell surface proteins, CD32B and CD79B. Simultaneous engagement of the CD32B and CD79B receptors triggers inhibition of B cell function and suppression of autoantibody production, thereby regulating B cells without causing depletion. Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder characterized by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies. PRV-3279 also has the potential to prevent or reduce the immunogenicity of biotherapeutics, including but not limited to gene therapy vectors and transgenes. Provention is currently evaluating PRV-3279 in the PREVAIL-2 (PRV-3279 EVAluation In Lupus) study; additional information on the clinical trial is available at www.clinicaltrials.gov (Number NCT05087628).

The placebo-controlled, double-blind, randomized study initiated will examine the efficacy and safety of PRV-3279 versus placebo, administered every four weeks for five months, followed by an eight-week efficacy and safety follow up. The primary endpoint of the study is to evaluate the ability of PRV-3279 to reduce SLE flare. The trial is expected to enroll approximately 100 adults with SLE across approximately 28 sites in the United States and Hong Kong. The Company and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd., have a strategic collaboration to develop and commercialize PRV-3279 in Greater China (mainland China, Hong Kong, Macau and Taiwan.)

About Provention Bio, Inc.:

Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company's pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including type 1 diabetes, celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

Internet Posting of Information:

Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following 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 relating to the timing of data from the PREVAIL-2 study and the potential for PRV-3279 to prevent or reduce the immunogenicity of biotherapeutics, its potential rapid inhibition of activated B cells, while sparing non-activated B cells from depletion or inactivation, and its potential to be an alternative to current B cell-targeting therapies with a more favorable safety profile. These statements may be identified by the use of forward-looking words such as "will," "believe," and "may," among others. 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 indicated by such forward-looking statements. These factors include, but are not limited to, risks related to delays in identifying and enrolling patients for the PREVAIL-2 study; delays in or failure to obtain FDA approvals for PRV-3279 or other Company product candidates;; 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; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2021 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, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

Investor Contacts:

Robert Doody, VP of Investor Relations
[email protected]

Media Contact:

Lori Rosen, LDR Communications
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917-553-6808

SOURCE Provention Bio, Inc.