Pipeline

Respiratory Infection

Pulmonary infections are caused by a wide variety of pathogens, many of which are multi-drug resistant and present significant treatment challenges. Microbion is focused on two key indications: pulmonary nontuberculous mycobacterial (NTM) infections and chronic cystic fibrosis (CF) pulmonary infections.

Pulmonary NTM Infections: Pulmonary NTM infections are the most common form of NTM disease, accounting for 65–90% of all NTM-related cases. Over 140 NTM species can infect humans and animals, but approximately 20 core species are responsible for 95% of clinical isolates. While there is currently one approved inhaled therapy for Mycobacterium avium lung infections, there are no approved treatments for M. abscessus infections, which pose an even greater threat due to their resistance and severity.

Cystic Fibrosis (CF) Lung Disease: CF lung disease affects more than 30,000 people in the US and 70,000 worldwide. It is characterized by chronic bacterial infection and severe inflammation, leading to progressive loss of lung function. Chronic pulmonary infections in CF patients, often involving Pseudomonas aeruginosa, are marked by persistence, biofilm formation, immune evasion, and resistance to multiple therapies. Multispecies biofilms formed by combinations of CF-relevant bacteria demonstrate greater resistance and pathogenicity than single-species biofilms. These complex biofilms are largely responsible for the chronic and persistent nature of CF lung infections, which drive ongoing morbidity and are ultimately the leading cause of mortality in this population. Chronic CF-related pulmonary infections also represent a major healthcare burden, resulting in significant loss of productivity, reduced quality of life, and premature death.

Our Solution

Pravibismane, with dual antimicrobial and anti-biofilm properties, represents a novel approach to treating resistant pulmonary infections, including those caused by NTM and in chronic CF lung disease. Preclinical inhaled toxicology studies with pravibismane have been completed, supporting the initiation of first-in-human clinical studies. Inhaled pravibismane has the potential to address critical unmet medical needs in both NTM and CF patient populations.

Beyond CF and NTM lung infections, many lower respiratory tract diseases—such as non-CF bronchiectasis, bronchitis, and community- or ventilator-associated pneumonia—are complicated by microbial pathogens and their associated biofilms, which contribute to lung function decline. With potent broad-spectrum anti-microbial and anti-biofilm activity, combined with anti-inflammatory properties, pravibismane may offer broad utility in the treatment of these and other pulmonary diseases. Pathogens such as Pseudomonas spp., Staphylococcus spp., Streptococcus spp., Mycobacterium spp., and Haemophilus spp. are commonly implicated in these conditions These diseases may also benefit from inhaled pravibismane therapy.

Pravibismane inhalation drug product has received Orphan Drug Designation from the US FDA for the treatment of both NTM infections and pulmonary infections in people with CF.