Explorebigsky.com Staff Writer
BOZEMAN – $2.5 million in federal grant money may help a Bozeman-based company change the future of the health industry.
Microbion Corporation is developing products related to antibiotic resistant bacteria and microbial biofilms, both in health and industry. Its focus is on an innovative new class of anti-infective drugs, one of the few discovered in the last 30 years.
The funding, awarded to a team consisting of Microbion; University of Pennsylvania; and University of California, San Francisco, will help facilitate Phase 2 human trials to treat post-surgical orthopedic infections with Microbion’s innovative antimicrobial drug, currently in regulatory development. Provided through the U.S. Department of Defense, the grants are part of the 2012 Congressionally Directed Defense Medical Research Program.
Clinical studies will be carried out at both the Hospital of the University of Pennsylvania, and at UCSF/San Francisco General Hospital. A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma & Fracture Service at the Perelman School of Medicine at the University of Pennsylvania, will work with Microbion and the University of California-San Francisco on the trial, set to begin pending FDA approval of the Investigational New Drug application.
“Orthopaedic trauma and fracture patients are at an increased risk for infection,” Mehta said. “If successful, this new treatment strategy could be a significant step toward reducing instances of amputation, disability and even death.”
This is Microbion’s second DoD grant in support of the regulatory development of this drug. Microbion’s BisEDT therapeutic drug successfully completed Phase 1 human trials in 2011.
“This is an important step for Microbion as we advance this drug to fight extremely challenging infections associated with orthopedic surgeries, including antibiotic resistant infections,” said Dr. Brett Baker, Microbion’s Founder, President and CEO.
In June 2012, the award team met with the FDA in Washington D.C. to discuss Microbion’s plan to advance to Phase 2 human clinical studies for the treatment of post-surgical infections associated with orthopedic medical devices.
In 2011, the World Health Organization identified antibiotic resistance as a global health crisis. aaIn response to this crisis, Congress passed the GAIN (Generating Antibiotic Incentives Now) Act in 2012 with broad bipartisan support. This legislation provides incentives and FDA regulatory priority to companies who are developing new drugs to fight antibiotic resistant infections.
An estimated 100,000 patients receiving orthopedic implants in the U.S. annually suffer from a post-operative infection.
“This is a critically important area for the global community, as almost all current antibiotics are losing effectiveness against resistant bacterial and fungal infections,” Dr. Baker said. “The rapidly expanding unmet need in healthcare is creating an international market that must be addressed as a matter of global necessity. Our technology has the potential to improve outcomes for patients who develop an infection related to an implanted orthopedic medical device.”