Redhill Biopharma received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering RHB-104, the company’s asset for Crohn’s disease, as well as RHB-204 for Mycobacterium avium complex (MAC) disease, the most common cause of pulmonary nontuberculous mycobacteria (NTM) infections1. The patent is expected to be valid until at least 2029.
Once this new patent is granted, the robust patent portfolio for RHB-104 will include seven issued U.S. patents, three of which also protect RHB-204, as well as additional issued and pending patents worldwide.
A pivotal Phase 3 study with RHB-204 for the treatment of pulmonary NTM infections is planned to commence in the second half of 2019, subject to completion of the ongoing supportive non-clinical program and additional input from the U.S. FDA. The study is intended to assess the efficacy and safety of RHB-204 and potentially support its approval as a stand-alone, first-line treatment for pulmonary NTM infections caused by MAC.
RHB-104 was evaluated in the MAP US study, a randomized, double-blind, placebo-controlled first Phase 3 study for Crohn’s disease. The study successfully met both its primary endpoint and its key secondary endpoints and presented the broad benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease, including anti-TNFs. RedHill plans to meet with the FDA in the second half of 2019 to discuss the development path toward potential approval of RHB-104, including the design of a confirmatory Phase 3 study.
RHB-204 is an antibiotic combination therapy in an oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.
Nontuberculous mycobacteria (NTM) are ubiquitous environmental bacteria, found in the soil as well as natural and engineered water systems. NTM infections have been increasing worldwide over the past two decades. Pulmonary manifestations account for 80–90% of all NTM-associated diseases, with approximately 80% of pulmonary NTM infections in the U.S. associated with mycobacterium avium complex (MAC). Pulmonary NTM disease symptoms can include fever, weight loss, chronic or recurring cough, chest pain, blood in sputum and fatigue. Treatment of NTM infection requires multiple antibiotics and an extended treatment course due to the risk of development of resistance. As a result, new antimicrobial agents for NTM are urgently needed.
RHB-204 was granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of NTM Infections.
RHB-104 is an antibiotic combination therapy in an oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.
RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by the Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients rather than being an autoimmune disease. RHB-104 is a multifaceted drug that in addition to bactericidal properties against intracellular infections, has potentially distinct mechanisms of action that include both anti-inflammation and neuroprotection.