Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI).
An investigational orally delivered biologic drug, LMN-201 is a cocktail of four therapeutic proteins that act synergistically to neutralise the C difficile bacterium and the toxin.
It is compatible with standard-of-care antibiotics.
The drug is GMP-manufactured by Lumen Bioscience in Seattle, US, and is intended to be given concomitantly with normal antibiotics and for eight weeks thereafter, offering protection from re-infection while commensal bacteria recolonise the gastrointestinal tract.
Pivotal trials on LMN-201 are expected to commence in 2023.
Lumen Bioscience co-founder and CEO Brian Finrow stated: “Fast track designation underscores the significant unmet need for treating and preventing CDI and the potential of LMN-201 to address this persistent gap in patient care.
“Recent advances in CDI recurrence prevention are inspiring but have yet to make a perceivable impact on the epidemic, due in significant part to inconvenient administration requirements.
“We are committed to advancing our clinical programme and bringing this innovative therapy to patients as quickly as possible, to provide relief to those suffering from this life-threatening disease.”
The company has already received FDA approval for a Phase II/III trial, which will begin to enrol 375 participants at sites across the US during 2023.
The placebo-controlled, double-blind trial will evaluate the ability of LMN-201 for improving treatment outcomes and preventing the recurrence of disease in recently diagnosed CDI patients.