Microbion Corporation Announces First Patient Treated in Phase 2a Orthopedic Infection Trial
BOZEMAN, MT, and VANCOUVER, BC – (Marketwired – June 16, 2016) – Microbion Corporation (“Microbion”) of Bozeman, MT, USA and Microbion Pharma Corp. of Vancouver, BC, Canada, specializing in the treatment of hard to treat and antibiotic-resistant infections, today announced that James Krieg, M.D., of Thomas Jefferson Hospital in Philadelphia, Pennsylvania, has enrolled the first patient in the Phase 2a study of MBN-101 for the treatment of orthopedic implant-related infections.
Thomas Jefferson Hospital is currently one of four clinical sites enrolling patients in this study. The other sites include the Orthopaedic Trauma and Fracture Service in the Department of Orthopaedic Surgery at the University of Pennsylvania, the Orthopaedic Trauma Institute at the University of California San Francisco, and the Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health.
MBN-101 is the lead drug candidate in a new class of drugs that Microbion is developing to combat difficult to treat infections, including multi-drug resistant infections. This Phase 2a study is partially funded by a grant #W81XWH-12-2-0100 from the U.S. Department of Defense (DOD), Military Infectious Diseases Research Program and managed by the University of Pennsylvania. The DOD has previously provided grants to Microbion supporting a wide range of non-clinical and Phase 1 human clinical studies of MBN-101. Microbion has already successfully completed a Phase 1 study of MBN-101 in healthy volunteers in the United Kingdom.
Leading orthopedic physicians, led by principal investigator Samir Mehta, M.D., Chief of the Division of Orthopaedic Trauma and Associate Professor of Orthopaedic Surgery at the Perelman School of Medicine, University of Pennsylvania, plan to enroll patients with implant-related orthopedic infections in this randomized, placebo-controlled, dose-ranging study. The objective of this trial is to evaluate both the safety, and ability of MBN-101 to improve patient outcomes associated with difficult to treat orthopedic infections. “When treating difficult infections associated with orthopedic implants, which are increasingly common, physicians urgently need more effective treatments,” said Dr. Mehta. “We are eager to evaluate MBN-101 as a potentially important new treatment for patients with orthopedic infections as it represents a new therapeutic approach which benefits from recent advances in our understanding of bacteria.”
“Having the first US patient enrolled in our Phase 2a study for MBN-101 is a significant milestone for Microbion and for the development of a potentially new medicine for patients who suffer from orthopedic device-related infections,” said Karim Lalji, Chairman & CEO of Microbion Pharma Corp. “Microbion is committed to the study of MBN-101 in multiple indications where difficult to treat and resistant infections are involved including the initiation of a Phase 2a study for the treatment of diabetic foot ulcer infections.”
About Microbion Corporation
Microbion is a clinical-stage biopharmaceutical company. Microbion is developing MBN-101 as the first product in a new class for the treatment of antibiotic-resistant and difficult to treat infections. MBN-101 has broad spectrum, anti-bacterial efficacy against a broad range of pathogens, including multiple priority pathogens or “superbugs”. In addition to anti-bacterial efficacy, MBN-101 has also demonstrated the ability to eradicate microbial biofilms. This dual antimicrobial action from this first-in-class product provides a novel clinical approach to treating infections. Microbion filed an IND in the United States for MBN-101 in 2015. The company initiated its first Phase 2a study in 2016. MBN-101 has been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for post-surgical orthopedic implant infections and was also granted Fast Track status for this indication by the FDA in 2015. The company has also been granted QIDP Designation by the FDA for adjunctive treatment of moderate and severe diabetic foot infections.
About Orthopedic Device Related Infections
There were over 2 million device-related orthopedic surgeries in the United States in 2015. There are also approximately 1 million traumatic fractures, in the United States annually. The infection rate related to the above conditions/surgeries can reach up to 20% in patients with risk factors including obesity, diabetes, and smoking, with significant patient morbidity and economic burden to the healthcare system. The cost of infected hip and knee replacements alone is projected to be over $1 billion annually in the United States.
About Chronic Wounds and Diabetic Foot Ulcers
Chronic wounds are wounds which have failed to heal effectively and in a timely manner. Chronic wounds affect approximately six million patients in the United States on an annual basis. The most common risk factors for developing chronic wounds include diabetes, vascular disease, and obesity. Bacterial infection and microbial biofilms are considered one of the main causes of impaired healing in chronic wounds. The most common chronic wound types are diabetic foot ulcers, venous leg ulcers and pressure ulcers. Chronic wounds represent a significant burden to patients, healthcare professionals and the U.S. healthcare system, costing an estimated $25 billion dollars annually. There are over 70,000 amputations annually on diabetic patients in the United States and 80% of diabetic amputations are preceded by an ulcer. There are over 100,000 hospitalizations in the U.S. annually for diabetic foot ulcers. The mention of any specific companies, commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government.
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 MBN-101 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 MBN-101 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of MBN-101 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of MBN-101 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.
Karim Lalji, Chairman & CEO
Microbion Pharma Corp.