LMN-201 for Prevention of C. Difficile Infection Recurrence

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence

This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.

Study Overview

• Status: Recruiting
• Conditions: Clostridioides Difficile Infection
• Intervention / Treatment: Drug: LMN-201; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 375
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Carl Mason; Phone Number: 12068991904; Email: trials@lumen.bio
• Study Contact Backup: Name: Asa Davis; Phone Number: 12068991904; Email: trials@lumen.bio

Study Locations

• United States
  • California
    • Escondido, California, United States, 90027
      • Recruiting
      • Kaiser Permanente
      • Contact: Primary Coordinator; Phone Number: 626-372-7499
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Recruiting
      • Bridgeport Hospital
      • Contact: Primary Coordinator; Phone Number: 203-384-4700
    • Hamden, Connecticut, United States, 06518
      • Recruiting
      • Gastroenterology Center of Connecticut
      • Contact: Primary Coordinator; Phone Number: 203-281-5112
  • Florida
    • Naples, Florida, United States, 34102
      • Recruiting
      • GI Pros Research
      • Contact: Primary Coordinator; Phone Number: 239-649-1336
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Recruiting
      • Metro Infectious Disease Consultants - Atlanta
      • Contact: Primary Coordinator; Phone Number: 404-297-5008
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Recruiting
      • Snake River Research
      • Contact: Primary Coordinator; Phone Number: 208-535-8406
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Recruiting
      • Metro Infectious Disease Consultants, LLC
      • Contact: Primary Coordinator; Phone Number: 630-655-8441
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • DM Clinical Research
      • Contact: Primary Coordinator; Phone Number: (708) 253-5810
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Recruiting
      • Baptist Health Research
      • Contact: Primary Coordinator; Phone Number: 859-639-3720
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Primary Coordinator; Phone Number: 612-625-2998
  • Montana
    • Butte, Montana, United States, 59701
      • Recruiting
      • Mercury Street Medical
      • Contact: Primary Coordinator; Phone Number: 406-723-1387
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Quality Clinical Research, Inc
      • Contact: Primary Coordinator; Phone Number: (402) 934-0044
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Primary Coordinator; Phone Number: 646-962-9358
      • Contact: Phone Number: 646-962-2085
  • North Carolina
    • Mount Airy, North Carolina, United States, 27030
      • Recruiting
      • IMA Clinical Research
      • Contact: Primary Coordinator; Phone Number: 336-415-5507
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Primary Coordinator; Phone Number: 3467251272
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Recruiting
      • Clinical Alliance for Infectious Diseases - Infectious Diseases, LLC
      • Contact: Primary Coordinator; Phone Number: 7035604821

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged 18 or older.
2. Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
3. Provision of signed and dated informed consent form.
4. Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
5. May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
6. Ability to take oral medication and willingness to adhere to the study medication regimen.
7. Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
8. Access to a mobile smartphone.
9. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration.
10. For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug administration.

Exclusion Criteria:

1. Fulminant C. difficile colitis.
2. Admitted or expect to be admitted to an intensive care unit.
3. Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
4. Neutropenia (absolute neutrophil count of < 1000 per microliter for any reason).

5. Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:

   1. Bezlotoxumab (Zinplava, Merck & Co.), or another antibody against C. difficile toxin(s)
   2. C. difficile vaccine
   3. SER-109 (Seres Therapeutics)
   4. CP101 (Finch Therapeutics)
   5. VE303 (Vedanta Therapeutics)
   6. Fecal microbiota transplant
   7. Current therapy with oral exchange resins
   8. Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study.)
6. Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
7. Pregnancy, anticipated pregnancy, or breastfeeding.
8. Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
9. Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.
10. Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
11. Status as an inmate, residential mental health program, or residential substance abuse program.
12. Terminal illness with limited life expectancy of less than 24 weeks.
13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.

14. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of the study.

    • Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.
    • Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Doses of placebo will be delivered as identical-appearing cornstarch with coloring in size 00, white, opaque, capsules.
Experimental: Sentinel Cohort	Drug: LMN-201; LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins: 3 toxin-binding proteins that bind and inhibit C. difficile toxin B (TcdB), an essential virulence factor for C. difficile; 1 lysozyme-like enzyme that selectively degrades the cell wall of C. difficile and causes rapid destruction of the organism
Active Comparator: LMN-201	Drug: LMN-201; LMN-201 consists of orally delivered whole, dried, non-viable biomass of spirulina (Arthrospira platensis) grown from 4 separate strains, each of which has been engineered to express one of the following therapeutic proteins: 3 toxin-binding proteins that bind and inhibit C. difficile toxin B (TcdB), an essential virulence factor for C. difficile; 1 lysozyme-like enzyme that selectively degrades the cell wall of C. difficile and causes rapid destruction of the organism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who achieve global cure	Proportion of total participants with both successful initial CDI treatment and no CDI recurrence during the Prevention and Observation Phases (by treatment assignment).	Up to 16 weeks after initiation of therapy

Collaborators and Investigators

• Sponsor: Lumen Bioscience, Inc.
• Collaborators: Congressionally Directed Medical Research Programs

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections
• Other Study ID Numbers: CDI02; CDMRP-PR221885 (Other Grant/Funding Number: CDMRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No