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RedHill Biopharma Announces FDA Clearance for Pivotal Phase

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midastouch017   Friday, 07/31/20 07:53:36 AM
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RedHill Biopharma Announces FDA Clearance for Pivotal Phase 3 Study with RHB-204 for NTM Infections

RHB-204 is a potential first-line oral treatment for pulmonary nontuberculous mycobacteria (NTM) infections, a rare disease with no FDA-approved first-line therapy
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The pivotal Phase 3 study aims to enroll 125 patients at 50 clinical sites across the U.S.
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RHB-204 was granted QIDP designation and is eligible for Fast-Track development, NDA priority review and a total of eight years of U.S. market exclusivity, if approved
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RedHill has also submitted to the FDA an Orphan Drug Designation application for RHB-204, which, if granted, will extend U.S. market exclusivity to a total of 12 years


TEL AVIV, Israel and RALEIGH, N.C., July 31, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a pivotal Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) infection.

Kevin L. Winthrop, MD, M.P.H., Professor of Infectious Diseases and Public Health at the Oregon Health & Science University - Portland State University (OHSU-PSU) School of Public Health and Principal Investigator of the study, said: “NTM infections are enormously challenging, resistant to most antibiotics, and can cause significant lung damage - and they are becoming more prevalent. There is a tremendous unmet need with regard to FDA-approved therapies for NTM, and both physicians and patients need additional treatment options.”

Gilead Raday, RedHill’s Chief Operating Officer, added: “There is currently no FDA-approved first-line, standard-of-care therapy for patients suffering from pulmonary NTM infections. We are looking forward to completing our discussions with FDA and initiating this pivotal study at leading clinical sites across the U.S., evaluating RHB-204 as a first-line, stand-alone, orally-administered therapy.”

RHB-204 was granted a Qualified Infectious Disease Product (QIDP) designation by the FDA under the Generating Antibiotic Incentives Now (GAIN) Act, which includes eligibility for Fast-Track development, NDA Priority Review and extended U.S. market exclusivity for a total of eight years, if approved. RedHill has also submitted to the FDA an Orphan Drug Designation application for RHB-204, which, if granted, will extend U.S. market exclusivity to a total of 12 years.

This multi-center, randomized, double-blind, placebo-controlled, parallel-group pivotal Phase 3 study, under ongoing discussion with the FDA, is planned to be conducted at up to 50 sites across the U.S. and aims to enroll 125 patients, randomized at a 3:2 ratio to receive either RHB-204 or placebo. The study is planned to evaluate the safety and tolerability of RHB-204, patient-reported outcomes, sputum culture conversion (SCC) by Month 6 of treatment with RHB-204, compared to placebo, and patients will continue to receive treatment for 12 months from SCC.

About Pulmonary Nontuberculous Mycobacteria (NTM) Infections
Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in soil as well as natural and engineered water systems. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum1. NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure2. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world3. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20174. Pulmonary manifestations account for 80-90% of all NTM-associated diseases5, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium Complex (MAC)6.

Treatment of NTM infection can be difficult, with no FDA-approved first-line standard-of-care therapy. It requires multiple antibiotics and an extended treatment course due to the risk of development of resistance.7 Many patients fail these types of therapies and more than half will have either recurring disease or a new infection after completing treatment.8 Thus, new treatment options for NTM are urgently needed.

About RHB-204
RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC). RHB-204 was granted QIDP designation and is eligible for an expedited development pathway and priority review, as well as a total of eight years of U.S. market exclusivity, if approved. RedHill has also submitted to the FDA an Orphan Drug Designation application for RHB-204, which, if granted, will extend U.S. market exclusivity to a total of 12 years. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.

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