As a result, the investigational, orally delivered drug, LMN-201, will now enter late-stage trials.
CDI is a bacterial infection closely associated with antibiotics use in hospitals, nursing homes, and other healthcare facilities.
It is the most common health care-associated infection in U.S. hospitals, causing nearly half a million cases and more than $5 billion in costs annually.
Antibiotic therapy is often successful in treating initial CDI cases, but 20 to 40% of patients will suffer a first recurrence within weeks. In studies with vulnerable patients, further recurrence rates sometimes exceed 50%.
Lumen describes LMN-201 as 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 and is GMP-manufactured by Lumen in Seattle.
The news comes after LMN-201 received FDA Fast Track designation earlier this year.
The late-stage REPREVE trial of LMN-201 will commence in Q4 2023 and enroll approximately 375 patients at sites across the U.S.
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.
Dr. Carl Mason, vice president of clinical affairs at Lumen Bio, said: “Existing drugs for preventing Cdiff are costly and extremely inconvenient to administer, so we’re excited about our chance to finally make a dent in U.S. CDI prevalence with this new therapeutic approach. 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.”