RedHill Biopharma Initiates Phase 3 Study Of RHB-204 For First-Line Treatment Of NTM Disease

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced that it has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy. "NTM is a debilitating disease that can cause scarring, fibrosis and the formation of cavities or pits in the lungs, which can lead to potentially fatal respiratory failure. People with existing lung conditions, such as bronchiectasis and those with COPD, are particularly susceptible," said Prof. Kevin Winthrop, MD, MPH, Professor of Infectious Diseases, Oregon Health & Science University, and study Principal Investigator. "NTM is notoriously resistant to most antibiotics and challenging to treat, and there is no FDA-approved first-line therapy for the approximately 110,000 cases of NTM infection in the U.S. This study of orally-administered RHB-204, if successful, represents an opportunity to make a breakthrough in managing NTM infections." "Treatment of NTM disease requires multiple antibiotics and an extended treatment course due to the risk of development of resistance1," said Aida Bibliowicz, RedHill's Vice President of Clinical Affairs. "Many patients fail these types of therapies and more than half will have either recurring disease or a new infection after completing treatment2, making new treatment options for NTM an urgent need."

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