November 13, 2024
Microbion Announces Positive Topline Results from Phase 2 Study of Topical Pravibismane for Moderately Infected Diabetic Foot Ulcers
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Microbion is a clinical stage biotechnology company dedicated to the development of its proprietary antimicrobial, anti-biofilm family of compounds as therapeutic agents for the treatment of infectious diseases, including those caused by antibiotic-resistant bacteria. Our lead drug candidate, pravibismane, is the first in a new class of anti-infectives. We have successfully completed three Phase 1 clinical studies to evaluate the safety of a topical/local formulation of pravibismane (MBN-101) in healthy volunteers. Subsequently, two additional clinical studies have been completed: a Phase 2a clinical study to evaluate the safety and efficacy of MBN-101 for the treatment of post-surgical orthopedic device-associated infections and a Phase 1b study to assess safety and preliminary efficacy of MBN-101 for treatment of moderate-to-severe diabetic foot ulcer (DFI) infections. The pre-clinical program for development of an inhaled formulation of pravibismane for treatment of pulmonary infections will be completed by mid-2021. Phase 1 clinical studies in healthy volunteers are planned to begin in late 2021/early 2022. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for treatment of orthopedic device related and moderate-to-severe DFI infections, as well as Orphan Drug, QIDP and Fast Track designations for the management of CF-related lung infections.
Microbion is working on advancing inhaled pravibismane towards completing GLP-tox studies and initiating first in human, healthy volunteer studies expected late 2021/early 2022. Planning of a proof of concept trial for topical pravibismane for the treatment of diabetic foot infection is also underway.
Microbion is seeking financing, dilutive and non-dilutive, to advance inhaled pravibismane through early stage clinical development for the treatment of chronic lung infection and topical pravibismane for diabetic foot infection towards approval. We are also looking for development and commercialization partnerships, including regional, for all pipeline programs. For more information, contact Edmond Lee (investors@microbioncorp.com).
November 13, 2024
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