LMN-201 Reduces C difficile Recurrence

The investigational oral biologic LMN-201 achieved statistically significant global cure in patients with Clostridioides difficile infection (CDI) in the phase 2 RePreve trial.¹ Global cure occurred in 83.3% of LMN-201 recipients vs 36.4% of placebo recipients, and recurrence fell from 55.6% to 9.1%.¹ The results will be featured as a late-breaking oral presentation at IDWeek 2026.¹

LMN-201 combines three toxin-binding proteins and an antibacterial enzyme, all produced in engineered spirulina and delivered in oral capsules.¹ The agent is designed for use during and after standard-of-care (SOC) antibiotics, targeting both primary treatment failure and recurrence.¹ According to the therapy’s developer, Lumen Bioscience, prior efforts to improve CDI outcomes have had limited impact, partly because of the high cost and inconvenient administration of existing preventive therapies.¹

In RePreve (NCT05330182), 45 participants with CDI received LMN-201 or placebo during and after SOC antibiotic treatment.¹ Part B was double-blinded and randomized 1:1, with stratification by SOC antibiotic and age.¹ The primary end point, global cure, combined successful primary treatment with prevention of recurrence.¹

Global cure was observed in 10 of 12 LMN-201 recipients (83.3%) vs 4 of 11 placebo recipients (36.4%).¹ The 47-percentage-point risk difference (odds ratio [OR], 8.75) met statistical significance under the prespecified analysis plan, although the announcement did not report a P value or CI.¹ Recurrence occurred in 9.1% of patients receiving LMN-201 plus SOC antibiotics vs 55.6% of those receiving SOC antibiotics plus placebo, a sixfold reduction.¹

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