pravibismane inhaled (MBN-101) / Microbion - LARVOL DELTA

Microbion Presented New Pravibismane Data Against Mycobacteroides abscessus at the 6th World Bronchiectasis and NTM Conference (Canada Newswire) - "Microbion Corporation today announced that the company presented a poster highlighting the results from a series of in vitro and in vivo studies characterizing pravibismane's effect against Mycobacteroides abscessus at the recent 6th World Bronchiectasis & NTM Conference...Pravibismane exhibited 16- to 32-fold lower MICs compared to amikacin in three M. abscessus strains tested (standard lab and cystic fibrosis patient isolates); In a chronic M. abscessus lung infection mouse model, unlike inhaled amikacin, inhaled pravibismane exhibited a statistically significant reduction in bacteria in lung homogenates when compared to vehicle control with an 18-fold reduction in CFU counts."

Preclinical • Cystic Fibrosis • Infectious Disease

Microbion Corp. Granted US Patent for the Use of Inhaled Pravibismane for Pulmonary Infections (Canada Newswire) - "Microbion Corporation today announced that the US Patent and Trademark Office (USPTO) issued United States Patent No. 11,464,749 to Microbion with claims to the use of Microbion's proprietary pravibismane inhaled composition for treatment of pulmonary infections. The patent, entitled 'Bismuth-thiol compositions and methods of use,' extends inhaled pravibismane patent protection through mid-2039."

Patent • Cystic Fibrosis

Microbion Corporation Announces Poster Highlighting Pravibismane Activity Against Common Cystic Fibrosis Pulmonary Pathogens to be Presented at the North American Cystic Fibrosis Conference 2022 (Canada Newswire) - "Microbion Corporation today announced that the company will present a poster at the North American Cystic Fibrosis Conference, November 3 – 5, in Philadelphia, PA highlighting the activity of pravibismane against bacterial pathogens associated with lung infection in people with cystic fibrosis (CF)....'We are excited to be sharing these data demonstrating that pravibismane is highly active against a broad spectrum of pathogens that commonly infect the airways of people with cystic fibrosis and contribute to the lung disease associated with cystic fibrosis,'...The company plans to advance an inhaled formulation of pravibismane into Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections."

Clinical data • Cystic Fibrosis • Infectious Disease

[VIRTUAL] Microbion Corporation (BIO 2021) - "Multiple pravibismane formulations are under development to target specialty markets representing over ~$4B in peak annual sales opportunity in the U.S. This includes inhaled pravibismane for treatment of Cystic Fibrosis and Nontuberculous Mycobacteria lung infections, and topical/local pravibismane for treatment of chronic wounds and orthopedic infections. Pravibismane’s unique potential has been validated through ~$27M in non-dilutive grants awarded to-date from CARB-X, Cystic Fibrosis Foundation, and and the U.S. NIH, Army, and Navy."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Orthopedics • Pulmonary Disease • Respiratory Diseases

Microbion Corporation Receives Additional Funding Support from the Cystic Fibrosis Foundation to Speed Advancement of Inhaled Pravibismane (PRNewswire) - “Microbion Corporation of Bozeman...today announced that it has received additional funding from the Cystic Fibrosis Foundation to speed the advancement of inhaled pravibismane for the treatment of cystic fibrosis (CF) related pulmonary infections. This new funding of up to $1.8 million will directly support IND-enabling toxicology studies...for a combined total of up to $7.4 million….’Working closely with the Foundation to advance the IND-enabling toxicology studies, targeted for completion in Q2 2021’….In the lab, pravibismane exhibits broad-spectrum, potent, and persistent antimicrobial activity against CF-relevant pathogens…as well as other multidrug-resistant pathogens."

Financing • Preclinical • Cystic Fibrosis

5N Plus Acquires Stake in Microbion and Secures Drug Substance Manufacturing Rights (Yahoo Finance) - "5N Plus Inc....and Microbion Corporation...jointly announced today that the parties have entered into a strategic relationship for the development, manufacturing and commercial drug substance supply of Microbion's new class of antibiotic and antibiofilm drugs. Under the terms of the agreement, 5N Plus has taken an equity stake in Microbion and will assume responsibility for the manufacturing of Bismuth-based Active Pharmaceutical Ingredients (API) required in Microbion's family of drug products currently under development, including the company's lead API, pravibismane."

Commercial • Cystic Fibrosis

Microbion Corporation announces Orphan Drug Designation granted for pravibismane suspension for inhalation by US FDA (Microbion Corp Press Release) - "Microbion Corporation of Bozeman, MT and Microbion Pharma Corp. of Vancouver, BC...today announced that the US FDA has granted orphan drug designation for inhalation delivery of pravibismane (BisEDT antimicrobial suspension) for '…treatment (management) of pulmonary infections in patients with cystic fibrosis'....Qualifies Microbion for various development incentives of the Orphan Drug Act including 7 years of market exclusivity in the U.S. Pravibismane..."

Orphan drug • Cystic Fibrosis • Infectious Disease

Microbion awarded up to $17.1 million from CARB-X and the Cystic Fibrosis Foundation to develop inhaled antimicrobial for chronic respiratory infections in CF (Microbion Corp Press Release) - "Microbion Corporation of Bozeman, Montana today announced it has been awarded up to US$17.1 million from CARB-X and the Cystic Fibrosis Foundation to advance the development of its antimicrobial drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections. The $11.5 million in funding from CARB-X and the up to $5.6 million in funding from the CF Foundation will enable Microbion to complete preclinical and Phase 1 studies. The award is comprised of an initial commitment of up to $6.1 million plus up to $5.4 million more if certain project milestones are met."

Financing • Cystic Fibrosis