Provention Bio Announces Initiation of Phase 2b PROACTIVE Study of PRV-015 (anti-IL-15) in Non-responsive Celiac Disease

Rhea-AI Summary

Provention Bio, Inc. (Nasdaq: PRVB) has initiated the Phase 2b PROACTIVE study of PRV-015, an anti-IL-15 monoclonal antibody, targeting Non-Responsive Celiac Disease (NRCD) in adults. This study aims to assess the safety and efficacy of PRV-015 versus placebo without requiring a gluten challenge. Approximately 220 participants will be enrolled across 40 sites in the U.S., Canada, and Europe. Previous trials showed that PRV-015 significantly reduced intestinal inflammation and symptoms in celiac patients. The collaboration with Amgen could yield milestone payments contingent on the study's success.

Positive

• Initiation of Phase 2b PROACTIVE study for PRV-015 targeting Non-Responsive Celiac Disease.
• Successful prior trials showed PRV-015 reduced intestinal inflammation and symptoms by 38%.
• Collaboration with Amgen could lead to $150 million milestone payment upon trial completion.

Negative

• None.

OLDWICK, N.J., Aug. 31, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the initiation of the Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) study of PRV-015, an anti-interleukin-15 monoclonal antibody, in adult celiac patients not responding to a gluten-free diet, a condition known as 'Non-Responsive Celiac Disease' (NRCD). Provention is developing PRV-015 under its 2018 collaboration with Amgen.

"Celiac disease remains the most prevalent autoimmune disease with no therapeutic treatment, and gluten-free diets are unable to effectively manage the disease in a large subset of patients, given the widespread use of gluten in foods, medications and consumer products, as well as the contamination of apparently 'gluten-free' products," said Peter H.R. Green, MD, Phyllis & Ivan Seidenberg Professor of Medicine; Director, Celiac Disease Center at Columbia University. "The long-term effects of the activation of the immune system by gluten in non-responsive celiac disease can be devastating, including the potential development of intestinal lymphoma. Based on prior data, PRV-015 represents an exciting therapeutic candidate to potentially intercept the damaging effects of contaminating gluten."

"PRV-015 has the potential to be the first-ever approved therapeutic for celiac disease," stated Francisco Leon, MD, PhD, Chief Scientific Officer and Co-Founder, Provention Bio. "We believe that PRV-015 is the only investigational candidate that has been shown in clinical studies to simultaneously reduce gluten-induced symptoms and markers of intestinal inflammation as compared to placebo. We look forward to expanding our clinical experience with this candidate, consistent with our mission to bring forward therapies designed to intercept or prevent immune-mediated diseases."

The placebo-controlled, double-blind, randomized study initiated will examine the efficacy and safety of three dose levels of PRV-015 versus placebo, administered every two weeks for six months. The study does not require a gluten challenge and patients are asked to maintain their usual diet. The trial is expected to enroll approximately 220 adults with NRCD across approximately 40 sites in the United States, Canada and Europe. The primary endpoint of the study is the efficacy of PRV-015 as measured by the CeD-PRO (Celiac Disease Patient-Reported Outcome).

PRV-015 has been studied in six completed clinical trials to date. In a prior randomized double-blind, placebo-controlled Phase 2a study in 63 adults with celiac disease, PRV-015 reduced intestinal inflammation and symptoms associated with celiac disease after a controlled gluten challenge as compared to placebo. Specifically, at 12 weeks, a decrease of 38% (p=0.02) % in the CeD-PRO symptom measure and a decrease of 38% (p=0.03) in intestinal intraepithelial lymphocytes was observed.

About the Co-Development Collaboration with Amgen:

In November 2018, Amgen and Provention Bio announced a licensing and co-development agreement for PRV-015 (also known as AMG 714). Under the terms of the agreement, Provention will conduct and fund the Phase 2b trial in non-responsive celiac disease (NRCD). Amgen will be responsible for the manufacturing of PRV-015. Upon completion of the Phase 2b trial, Provention will be eligible to receive a $150 million milestone payment, as well as additional regulatory milestone payments and royalties if Amgen continues the development of this product candidate.

About PRV-015:

PRV-015 (also known as AMG 714) is a novel, fully human anti-IL-15 monoclonal antibody which Provention is developing for the treatment of gluten-free diet non-responsive celiac disease (NRCD). The pro-inflammatory cytokine interleukin 15 (IL-15) has been identified as a major mediator in the pathophysiology of celiac disease. PRV-015 binds to and inhibits IL-15 and has emerged as a leading investigational candidate for the treatment of non-responsive celiac disease, in which patients continue to have disease activity despite an ongoing gluten-free diet. In a Phase 2a clinical trial with 63 celiac patients, data showed a reduction in inflammation and symptoms as compared to placebo after a controlled gluten challenge. Provention is currently evaluating PRV-015 in the Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) Study. PRV-015 is being developed under Provention's 2018 licensing and co-development agreement with Amgen. More information on the study is available at https://proactiveceliac.com/.

About Non-responsive Celiac Disease:

Celiac disease is a systemic autoimmune disease triggered by gluten consumption in genetically susceptible individuals. Approximately 1% of the western population is affected by celiac disease. The pathophysiology of celiac disease is characterized by an abnormal immune response to gluten, the main protein present in some of the most common cereals (wheat, barley, rye). Modern diets are increasingly enriched with gluten and it is also used as an additive in processed foods, cosmetics and oral medications. Gluten is also present in trace amounts in foods labeled as "gluten-free", as a tableting excipient, and in certain consumer products. As a result of the difficulty in maintaining total avoidance of gluten while on a gluten-free diet (GFD), gluten contamination causes 50% or more of all diagnosed celiac patients on a GFD to continue to experience disease activity. Patients who continue to have symptoms despite attempting to maintain a GFD are deemed to have NRCD.  Approximately 1.5 million patients in the U.S. have NRCD.  Celiac disease causes debilitating symptoms and serious medical complications, including intestinal mucosal damage which could lead to intestinal lymphoma. There are no approved medications for celiac disease.

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 studies, the potential health benefits of and planned research and development efforts for PRV-015. 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

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SOURCE Provention Bio, Inc.

FAQ

What is the purpose of the Phase 2b PROACTIVE study for PRV-015?

The study aims to evaluate the efficacy and safety of PRV-015 in treating Non-Responsive Celiac Disease in adults.

Where will the PROACTIVE study for PRV-015 take place?

The study will be conducted at approximately 40 sites across the United States, Canada, and Europe.

What were the results of previous trials involving PRV-015?

Previous trials indicated that PRV-015 reduced intestinal inflammation and symptoms by 38% compared to placebo.

What are the expected outcomes of the PROACTIVE study?

The primary outcome is to assess the efficacy of PRV-015 measured by the CeD-PRO (Celiac Disease Patient-Reported Outcome).

What is the significance of the collaboration with Amgen?

Amgen is responsible for manufacturing PRV-015, and Provention could receive significant milestone payments based on the trial's success.