Microbion Corporation Announces Data Highlighting In Vitro Activity of Pravibismane in NTM, including Activity Against NTM Causing Intracellular Infections, to be Presented at the Colorado Mycobacteria Conference 2022

BOZEMAN, Mont., June 1, 2022 /PRNewswire/ - Microbion Corporation today announced that the company will present a poster highlighting the in vitro activity of pravibismane against M. avium and M. abscessus non-tuberculous mycobacteria (NTM) at the Colorado Mycobacteria Conference 2022: Focus on NTM conference taking place from May 31 to June 3, 2022, at Colorado State University. The objectives of the in vitro study were: 1) Determine antimicrobial activity of pravibismane against M. avium and M. abscessus; and 2) investigate the ability of pravibismane to reduce intracellular NTM burden in infected human cell lines. 

The poster highlights:

• In broth culture, pravibismane demonstrated most potent MIC of 0.3125 µg/ml against M. avium and M. abscessus, superior to control drugs rifampin and amikacin, respectively.
  
  
• Pravibismane demonstrated an MIC of 0.3125 µg/mL and 0.625 µg/mL and against M. avium and M. abscessus intracellular infection in THP-1 cells, respectively.
  
  
• As low as 2.5 µg/mL pravibismane reduces intracellular M. avium 2285R (MDR) and M. abscessus 1153 (MDR) burden, superior to 20 µg/mL rifampin and amikacin control drugs, respectively.
  
  
• Pravibismane treatment is not toxic to THP-1 and A549 cells (≥95% cell viability).

Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics. With a novel mechanism of action, pravibismane shuts down bacterial ATP production thereby halting global bacterial cellular metabolism. Pravibismane exhibits broad-spectrum, potent in vitro activity against chronic respiratory infection-relevant pathogens and their biofilms including NTM, multidrug resistant P. aeruginosa and MRSA. An inhalation formulation of pravibismane is on track to initiate first-in-human studies in early 2023. Financial support for IND-enabling studies for this program was provided by CARB-X.

Non-tuberculous mycobacterial pulmonary infection is an orphan lung disease that may affect as many as nearly 180,000 individuals annually in the United States and its incidence is increasing.¹ NTM symptoms include cough, sputum production, dyspnea, hemoptysis, fever, night sweats, depression, fatigue, malaise, and weight loss.² Current NTM guidelines recommend using combinations of chronic, systemic antibiotic therapies that are potentially associated with adverse effects with long term use. The presence of biofilms produced by NTM further complicates treatment regimens and duration.³ Significant unmet needs exist to develop more effective antibiotics with less toxicity, eliminate intravenous methods of delivering antibiotics, shorten duration of treatment, and reduce patients' burden of disease^{.4, 5}

1. Strollo SE, Adjemian J, Adjemian MK, et al. The burden of pulmonary nontuberculous mycobacterial disease in the United States. Ann Am Thorac Soc. 2015;12(10):1458–1464. doi: 10.1513/AnnalsATS.201503-173OC
2. Pravosud V, Mannino DM, Prieto D, et al. Symptom burden and medication use among patients with nontuberculous mycobacterial lung disease. Chronic Obstr Pulm Dis. 2021;8(2):243-254. doi: 10.15326/jcopdf.2020.0184
3. Falkinham, JO. Challenges of NTM drug development. Front Microbiol. 9:1613. doi: 10.3389/fmicb.2018.01613
4. Chalmers JD, Akasamit T, Carvalho ACC, et al. Non-tuberculous mycobacterial pulmonary infections. Pulmonol. 2018;24(2):120 – 131. doi: 10.1016/j.pulmoe.2017.12.005
5. Henkle E, Aksamit T, Barker A, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection: An NTM Research Consortium Workshop Report. Ann Am Thorac Soc. 2016;13(9):S379–S384. doi: 10.1513/AnnalsATS.201605-387WS

Disclaimer: Research reported in this press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany's Federal Ministry of Education and Research, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.

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 a novel mechanism of action offering unique potential to address the unmet needs of chronic and severe health conditions. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane with Orphan Drug, Fast Track, and QIDP designations. Microbion Pharma Corp. is a wholly owned subsidiary of Microbion Corporation. For more information visit: www.microbioncorp.com.

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.

SOURCE Microbion Corporation