BiomX Inc has announced that the first 2 patients have received BX004 as part of its phase 1b/2a study assessing the novel drug for treating chronic respiratory infections in patients with cystic fibrosis (CF).

The company plans to treat 8 patients with CF in the first part of the study and to have initial data available by the third quarter of 2022.

In prior in vitro studies, BX004 “demonstrated activity against antibiotic-resistant strains of [Pseudomonas aeruginosa], as well as enhanced biofilm penetration compared to antibiotic therapies,” Jonathan Solomon, chief executive officer of BiomX, said in a press release. “We are pleased to reach this important clinical milestone in our cystic fibrosis program,” he added.

The current study is composed of 2 parts. The first part is aimed at evaluating the safety, pharmacokinetics, and clinical activity of BX004 in the 8 initial patients in single ascending and multiple doses. Part 2 will expand the patient group to 24 patients, who will be randomized 2:1 to receive either treatment or placebo, with results expected in early 2023.

Read more about CF therapies

BX004 is a novel phage therapy intended to treat CF patients with chronic respiratory infections due to Pseudomonas aeruginosa. In September 2021, it was cleared by the US Food and Drug Administration (FDA) for use in a phase 1b/2a trial in these patients.

According to a prior compassionate use program in the United States, phage therapy led to improved respiratory function and reduced bacterial burden in patients with CF.

Reference

BiomX announces dosing of the first two patients in phase 1b/2a study of BX004 for treatment of chronic respiratory infections in patients with cystic fibrosis. News Release. BiomX Inc; June 27, 2022.