Lumen Seeks Partner Take Its C. Into Phase III

Lumen Bioscience thinks preventing recurrence of Clostridioides difficile infections (CDI) could offer a major market opportunity and the privately held firm is looking for a larger partner to help take its oral biologic cocktail, LMN-201, into Phase III after the candidate yielded global cure in over 83% of patients in a small, placebo-controlled Phase II trial.

LMN-201 combines three toxin-binding proteins and an antibacterial enzyme – all new molecular entities – with the Seattle-based company’s proprietary spirulina-based GMP manufacturing system to create an oral therapy with strong binding avidity that can be manufactured at large scale, CEO Brian Finrow told Scrip in an interview.

In data from Part B of the 45-patient Phase II RePreve study reported on Oct. 21, the candidate dosed on top of standard-of-care antibiotics in patients diagnosed with CDI produced global cure (initial cure with no recurrence) in 83.3% (10/12) of patients versus 36.4% (4/11) who received standard of care, oral vancomycin or fidaxomicin, plus placebo. The 47% delta between the treatment and control arms was statistically significant in accordance with a prespecified statistical analysis plan, Lumen reported.

In addition, the study yielded a six-fold reduction in CDI recurrence for the treatment arm (9.1% recurrence rate) versus the control arm (55.6%). LMN-201 also showed a favorable directional trend on reduced primary cure failure compared to placebo in the study, with a safety profile and adverse-event rate similar to placebo and consistent with the underlying infection and standard-of-care treatment, the firm added.

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