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

• 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. January 30, 2024 -- 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:www.microbioncorp.com.