LMN-201 / Lumen Bio - LARVOL DELTA

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Active, not recruiting | Sponsor: Lumen Bioscience, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2027 ➔ Dec 2026 | Trial primary completion date: Jun 2027 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Recruiting | Sponsor: Lumen Bioscience, Inc. | Trial completion date: Apr 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Jun 2027

Trial completion date • Trial primary completion date • Infectious Disease

New investigational agents for the treatment of clostridioides difficile infections. (PubMed, Expert Opin Investig Drugs) - "Ibezapolstat, CRS3123, and ridinilazole were identified with unique mechanisms of action and narrow spectrums of activity that result in gut microbiome preservation and reduced recurrent CDI (rCDI) rates...Some have the ability to restore the microbiome (VE303) or preserve intestinal integrity (e.g. REC-3964, LMN-201, AQ)...CDI is a significant burden to the healthcare system and the quality of life for patients who suffer from CDI and rCDI. Further development of these investigational agents to prevent this cycle are of upmost importance."

Journal • Review • Infectious Disease

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Recruiting | Sponsor: Lumen Bioscience, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Not yet recruiting | Sponsor: Lumen Bioscience, Inc. | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Infectious Disease

Lumen Bioscience Receives Fast Track Designation from U.S. FDA for LMN-201 (PRNewswire) - "Lumen Bioscience...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for LMN-201, an investigational, orally delivered biologic drug to treat and prevent C. difficile infection (CDI)."

Fast track designation • Infectious Disease

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects. (PubMed, Biomedicines) - "Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons...The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI."

Journal • Review • Developmental Disorders • Infectious Disease

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Not yet recruiting | Sponsor: Lumen Bioscience, Inc. | Trial completion date: Dec 2023 ➔ Dec 2025 | Initiation date: Sep 2022 ➔ Apr 2023 | Trial primary completion date: Sep 2023 ➔ Apr 2025

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease

LMN-201 for Prevention of C. Difficile Infection Recurrence (clinicaltrials.gov) - P2/3 | N=375 | Not yet recruiting | Sponsor: Lumen Bioscience, Inc.

New P2/3 trial • Infectious Disease

Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Lumen Bioscience, Inc. | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Feb 2022

Trial completion • Trial completion date • Infectious Disease

Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Lumen Bioscience, Inc. | Trial completion date: Nov 2021 ➔ Jul 2022 | Trial primary completion date: Oct 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Infectious Disease

Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Lumen Bioscience, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Lumen Bioscience, Inc.

Clinical • New P1 trial • Infectious Disease