Trial Set for Gut Infection Biologic Treatment

C. difficile bacteria in petri dish (CDC.gov)

18 Apr. 2022. A developer of biologic therapies for gastrointestinal disorders says FDA cleared its request for a clinical trial testing its treatment for C. difficile infections. Lumen Bioscience Inc. in Seattle says the new trial will assess its experimental biologic therapy code-named LMN-201 designed to treat Clostridium difficile or C. difficile infections.

C. difficile is a common bacterial infection often contracted in hospitals or clinics. Centers for Disease Control and Prevention says nearly 224,000 C. difficile infections occurred in the U.S. in 2017, the last year for which data were collected, leading to 12,800 deaths. These infections often cause inflammation in the colon, with symptoms including watery diarrhea, abdominal pain, nausea, loss of appetite, and fever. Elderly patients and those receiving care for other illnesses or conditions requiring prolonged use of antibiotics are considered at greater risk of the disease.

Lumen Bioscience is a five year-old biotechnology enterprise that designs biologic therapies, including antibodies, for gastrointestinal and other disorders. The company’s platform is based on genetically engineered spirulina, a blue-green algae used for centuries as a food source and today as a nutritional supplement. Lumen Bio says it alters spirulina chromosomes with an added molecule, such as an antibody, which spirulina cells then produce as the algae grows.

The company says this process is faster, less expensive, and less risky than most other biologic development technologies. According to Lumen Bio, growing spirulina requires only water, salt, light, and carbon dioxide, making it an inexpensive and scalable process. The company dries the engineered algae, leaving a powder with the therapeutic molecules that are then formulated into capsules. While spirulina do not survive the drying process, says Lumen Bio, their cell membranes protect the therapeutic molecules through the stomach, with those molecules then released in the small intestine.

Delivers contents to targeted region

LMN-201, says the company, combines two types of protein therapies to treat C. difficile. The biologic includes three proteins acting like antibodies that bind to and neutralize toxins from the bacteria responsible for diarrhea and other severe symptoms associated with the disease. A separate endolysin enzyme in LMN-201 derived from bacteriophages destroys cell walls of the bacteria themselves.

In data from a preclinical study posted in January 2022 (but not yet peer-reviewed), Lumen Bio researchers found the antibodies in LMN-201 are up to 3,000 times more potent against C. difficile bacterial toxins than a monoclonal antibody currently approved to treat the disease. The company says a recently completed early-stage study in Australia shows LMN-201 delivers and releases its contents in the region of the small intestine where C. difficile is likely to develop. In addition, the delivered proteins remain stable over time, even in a digestive environment.

“Lumen’s platform,” says medical research director Carl Mason in a company statement, “enables this novel approach of combining multiple therapeutic proteins into a single, low-cost, easily distributed, and administered therapeutic.”

Lumen Bio says the Food and Drug Administration approved the company’s investigational new drug or IND application, officially a request to transport an experimental drug across state lines. An approved IND request is, in effect, clearance to begin a clinical trial. The mid-stage trial in this case plans to enroll 375 adult patients with C. difficile, although locations for recruiting participants are not yet disclosed. Participants are randomly assigned to receive LMN-201 or a look-alike placebo, and then tracked for 16 weeks. The study team is looking primarily for recurrence of C. difficile among participants.

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