Company plans to start recruiting for its REPREVE study this year.
This funding will support late-stage trials of the oral biologic.
The therapy, LMN-201, may present a potential alternative to existing drugs for C difficile prevention and treatment.
LMN-201 is based on research from Mass Bio and Merck and functions by neutralizing the toxins associated with C difficile infection, similar to how antivenom neutralizes snake venom.
Lumen Bioscience announced this week it was awarded $16.2 million by the US Department of Defense to advance its investigational C difficile therapy, LMN-201, through late-stage trials. LMN-201 is an oral biologic to treat and prevent the infection. Lumen will start recruiting for its REPREVE trial at sites across the US during the fourth quarter of this year.
“We are committed to moving LMN-201 into and through late-stage trials as quickly as possible to get it into the hands of those suffering from this terrible life-threatening disease,” Carl Mason, MD, MPH, Lumen Bio’s VP, clinical affairs, said in a statement.
The REPREVE trial will enroll approximately 375 patients at sites across the US. The double-blind, placebo-controlled study will assess LMN-201’s ability to both improve treatment outcomes and prevent recurrence in recently diagnosed CDI patients.
Earlier this year, Lumen announced it had received Fast Track Designation from the FDA for the therapy.
According to Lumen, LMN-201 is a complex biologic cocktail of therapeutic proteins that act synergistically to neutralize both the C difficile bacterium and the toxin that causes its virulence directly in the patient’s gastrointestinal tract. Taken orally in capsules, it is compatible with standard-of-care antibiotics.
In an interview with Contagion earlier this year, Lumen Bioscience Cofounder and CEO Brian Finrow explained LMN-201 is based off former research from Mass Bio and Merck and the creation of an antibody against C diff.
“What they found is that if you make an antibody against the C difficile toxin, the disease in humans is mediated by this toxin called toxin B…If you make an antibody, it'll neutralize the toxins just like snake antivenom,” Finrow said.
According to the company, medical providers interested in participating in the trial are encouraged to contact Lumen’s clinical operations team at trials@lumen.bio or through the trial site: www.reprevetrial.com. A history of prior CDI recurrence is not required for enrollment.
