Pharma Focus Asia

Microbion Corporation Announces Orphan Drug Designation Granted for Pravibismane Suspension for Inhalation by US FDA

Thursday, May 28, 2020

Microbion Corporation of Bozeman, MT and Microbion Pharma Corp. of Vancouver, BC ("Microbion") 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.

"We are pleased to have been granted orphan drug designation for our pravibismane inhalation program," said Mr. Karim Lalji, Chairman and CEO of Microbion Pharma Corp. "This designation is consistent with our steadfast commitment to develop innovative solutions to manage chronic pulmonary infections in patients with CF. We will work closely with the FDA and key stakeholders to advance inhaled pravibismane toward regulatory approval for the benefit of patients with cystic fibrosis."

Orphan drug designation qualifies Microbion for various development incentives of the Orphan Drug Act including 7 years of market exclusivity in the U.S. Pravibismane (inhaled suspension formulation) has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA, for the management of cystic fibrosis (CF)-related pulmonary infections.

Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics with a mechanism of action that functions as a microbial bioenergetic inhibitor. Pravibismane exhibits broad-spectrum antimicrobial activity against CF-relevant pathogens including carbapenem- and multidrug-resistant Pseudomonas aeruginosa, as well as other multidrug-resistant pathogens that are recognized as serious threats to CF patients. Pravibismane also demonstrates potent activity against the microbial biofilms formed by these bacterial pathogens. Biofilms protect bacterial pathogens from most antibiotics and host immune system defense mechanisms, thereby contributing to the chronic and persistent nature of CF-related pulmonary infections.

About Cystic Fibrosis

Cystic Fibrosis (CF) lung disease, which is estimated to affect more than 30,000 in the US and 70,000 worldwide, is characterized by chronic bacterial infection and severe inflammation that lead to progressive deterioration in lung function. Chronic pulmonary infections in CF patients, a significant portion of which involve Pseudomonas aeruginosa, are characterized by persistence, biofilm formation, evasion from immune responses, and resistance to multiple therapeutic agents. Furthermore, patients co-infected with additional CF-relevant bacteria resulting in multispecies biofilms have demonstrated greater resistance, virulence, and pathogenicity compared to single-species biofilms, thereby complicating treatment. Biofilms protect bacteria from traditional antibiotics as well as the host immune system, and they are implicated in the persistence of lung infections despite long-term therapeutic intervention. Chronic, CF-related pulmonary infections represent a major health care burden, being responsible for significant loss of productivity, reduced quality of life, morbidity, and premature mortality.

About Microbion

Microbion is a clinical-stage biopharmaceutical company developing pravibismane as the first product in a new class of anti-infective drugs with a mechanism of action that functions as a microbial bioenergetic inhibitor for the local treatment of antibiotic-resistant and difficult to treat infections. Pravibismane has antibacterial efficacy against a broad spectrum of pathogens, including multiple priority pathogens or "superbugs" identified by the US CDC. In addition to antibacterial efficacy, pravibismane has also demonstrated the ability to eradicate microbial biofilms. This dual antimicrobial action may offer a much-needed, novel, clinical approach to treat infections. Microbion has been granted QIDP and Fast Track designations for multiple indications and Orphan Drug Designation for the treatment (management) of pulmonary infections in patients with cystic fibrosis by the US FDA. In addition, Microbion has completed two clinical trials of pravibismane in diabetic foot ulcer (DFI) and orthopedic implant device infections and is continuing the clinical advancement of pravibismane for these indications. The International Nonproprietary Name (INN) recommended by the WHO of pravibismane is the first member in the bismane class which represents a novel class of anti-infective drugs. Microbion Corporation has previously closed a Series A financing of US$25M from GHS Fund (Quark Venture LP and GF Securities).

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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.


Investor/Media Contact:
Guy Cipriani
Chief Business Officer
Microbion Corp.

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