Pharma Focus Asia

BiomX Completes Patient Dosing in Phase 1b/2a Study for BX004 in Cystic Fibrosis

Friday, October 06, 2023

BiomX has announced the successful completion of patient dosing in the second part of its
phase 1b/2a clinical trial assessing BX004, a novel treatment aimed at addressing chronic
pulmonary infections resulting from Pseudomonas aeruginosa in individuals diagnosed with
cystic fibrosis (CF).

BX004 has been specifically developed to address a pressing unmet medical need affecting
numerous cystic fibrosis (CF) patients who are in dire need of innovative therapies to combat
persistent and life-threatening lung infections.

This novel treatment has been created using BiomX's proprietary BOLT platform, with the
primary goal of addressing chronic pulmonary infections caused by Pseudomonas aeruginosa
(P. aeruginosa), a leading contributor to the morbidity and mortality observed in CF patients.

The phase 1b/2a trial for BX004 consists of two distinct parts. Part 1 of the study has reported
positive outcomes, focusing on the assessment of safety, pharmacokinetics, as well as
microbiologic and clinical activity. This part involved nine CF patients and followed a single
ascending dose and multiple dose design.

Part 2 of the trial is set to evaluate the safety and efficacy of BX004 in a larger cohort, involving
at least 24 CF patients who will be randomly assigned to either a treatment or placebo group in a
2:1 ratio.

In August 2023, the FDA granted BX004 fast track designation for its potential in treating
chronic respiratory infections caused by Pseudomonas aeruginosa (PsA) bacterial strains in CF
patients.

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