Lumen Bioscience awarded $16.2 million in DoD funding to advance LMN-201 through late-stage trials

Orally delivered biologic drug to treat and prevent C. difficile
infection to start recruiting for late-stage trials in Q4 2023

SEATTLE, Oct. 17, 2023 /PRNewswire/ -- 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 protected] or through the trial site: www.reprevetrial.com. A history of prior CDI recurrence is not required for enrollment.

About Lumen 

Lumen Bioscience discovers, develops, and manufactures biologic drugs for highly prevalent diseases—many of which currently lack effective treatments. The company's unique drug development and manufacturing platform is transforming the biologics industry through increased speed, mass-market scale, and exponentially lower costs than have been possible with legacy technologies. Lumen's clinical pipeline includes investigational biologic drugs for C. difficile infection, Covid-19, cardiometabolic disease, inflammatory bowel disease, and traveler's diarrhea. For more information, visit: www.lumen.bio.

About the Funding Agency, CDMRP

The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $16.2 million, through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Program (CDMRP) under Award Number HT94252310959. Opinions, interpretations, conclusions, and recommendations contained herein are those of the author(s) and are not necessarily endorsed by the Department of Defense.

SOURCE Lumen Bioscience