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

Optimize Your trial insights with Clival Database.
Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.
With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.
To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.
Elevate your trial success rate with the cutting-edge insights from Clival database.
Check it out today and make more informed sourcing decisions! Learn More!