Microbion's Pravibismane Granted Second FDA Orphan Drug Designation for the Treatment of Non-tuberculous Mycobacterial (NTM) Infections

2024-01-30

孤儿药快速通道临床2期合格传染病产品临床1期

Second orphan drug designation granted for pravibismane, in addition to the treatment of pulmonary infections in patients with cystic fibrosis Pravibismane demonstrated statistically significant in vivo efficacy against NTM in chronic and acute infection models BOZEMAN, MT and VANCOUVER, BC, Jan. 30, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has been granted a second orphan drug designation for its lead drug candidate, pravibismane, for the treatment of non-tuberculous mycobacterial (NTM) infections. NTM infections are most commonly found in the lungs; however, skin and soft tissue, indwelling medical devices, lymph nodes, and blood can also harbor NTM infections. "We are pleased that the FDA has granted pravibismane this second orphan drug designation for the treatment of NTM infections," said Dr. Jeff Millard, Microbion's Chief Scientific Officer. "Our in vitro and in vivo data for the activity of pravibismane against pulmonary NTM infections and related biofilms, demonstrate unique and highly differentiated, potent activity compared to other agents currently used to treat NTM, while being well tolerated. We look forward to working closely with all our stakeholders and patients to advance the development of pravibismane for the treatment of NTM infections." "This designation comes at an opportune time as Microbion plans to initiate a Phase 3 program for topical pravibismane treatment of chronic wounds and a Phase 1 program with inhaled pravibismane for treatment of NTM lung infections," said Karim Lalji, Chief Executive Officer. "In an in vivo study using a chronic NTM lung infection model, inhaled pravibismane demonstrated an over 18-fold reduction of M. abscessus, the most pathogenic and rapidly growing species, for which no approved therapy exists. We are encouraged by the potential of pravibismane to address the critical unmet need of NTM infections." The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose, or treat a rare disease or condition, defined as any disease or condition that affects fewer than 200,000 persons in the United States. Orphan drug designation qualifies Microbion for various development incentives of the Orphan Drug Act, including seven years of market exclusivity. About Microbion Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion's lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action, including potent broad spectrum anti-infective, antibiofilm, and anti-inflammatory activity, offering unique potential to address the unmet needs of chronic and severe health conditions. Topical pravibismane is completing Phase 2 development for the treatment of chronic wounds. Local pravibismane is in Phase 2 clinical development for orthopedic infections and inhaled pravibismane is advancing into Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $20 million in grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and Qualified Infectious Disease Product (QIDP) designations. For more information visit: . Safe Harbor Statement Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.