LoA Update: Locus’ UTI therapy sees 2-point decrease in FDA approval shot despite positive Phase Ib, but still has 92% possibility of regulatory success

Locus Biosciences’ Escherichia coli urinary tract infection (UTI) asset LBPEC-01 had a two-point drop in its FDA likelihood of approval (LoA) as of 26 February even with positive Phase Ib data. Although its approval prospects decreased, the therapy’s current LoA remains high at 92%, according to GlobalData analysis using a combination of machine learning and its proprietary algorithm.

LBPEC-01 is a CRISPR-Cas3-enhanced bacteriophage (crPhase) approach that targets E. coli in patients with UTI. On 24 February, the North Carolina-headquartered company reported the 36-patient Phase Ib demonstrated LBP-EC01 use can decrease levels of susceptible bacteria in patients with E. coli in the bladder, with no reported drug-related adverse events. The trial had a primary endpoint investigating safety and therapy pharmacokinetics. Locus plans to advance LBPEC-01 into Phase II exploration, as per a media release.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.