— Orally delivered biologic drug to treat and prevent C. difficile infection to start recruiting for late-stage trials in Q4 2023
Seattle, WA, October 17, 2023 – Lumen Bioscience—a clinical-stage biotechnology company developing biologic drugs for highly prevalent diseases, today announced it was awarded $16.2 million by the U.S. Department of Defense to advance LMN-201 through late-stage trials. LMN-201 is an investigational, orally delivered biologic drug to treat and prevent C. difficile infection (CDI).
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%-40% of patients will suffer a first recurrence within weeks. In studies with vulnerable patients, further recurrence rates sometimes exceed 50%.
“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.” said Dr. Carl Mason, Lumen Bio’s VP, clinical affairs. “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.”
LMN-201 is an investigational drug—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. LMN-201 received FDA Fast Track designation earlier this year, and Lumen’s pre-clinical data published last fall.
The REPREVE Trial of LMN-201 will enroll approximately 375 patients at sites across the U.S., with recruitment outreach beginning in Q4 2023. 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. Physicians interested in participating are encouraged to contact Lumen’s clinical operations team at email@example.com or through the trial site: www.reprevetrial.com. A history of prior CDI recurrence is not required for enrollment.