Therapy Areas: Hereditary Disorders
First Two Patients Dosed in Phase 1b/2a Study of BX004 for Treatment of Chronic Respiratory Infections in Patients with Cystic Fibrosis
29 June 2022 - - The first two patients have been dosed in US-based clinical-stage microbiome company BiomX Inc's (NYSE American: PHGE) Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis, the company said.

BiomX is developing BX004 for the treatment of CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF.

In September 2021, BX004 was cleared by the US Food and Drug Administration to initiate a Phase 1b/2a study in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa.

The Phase 1b/2a study of BX004 is composed of two parts. Part 1 of the study will evaluate the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022.

Part 2 of the study will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2: 1 ratio.

Results from Part 2 are expected in 1Q23.

In January 2022, BiomX received a Therapeutics Development Award of up to USD5 m from the Cystic Fibrosis Foundation.

The award is structured as an equity investment in which the CF Foundation has agreed to purchase up to USD 5m of BiomX common stock across two separate tranches.

The first tranche was received on December 21, 2021, with the CF Foundation making an initial equity investment of USD 3m.

BiomX is a clinical-stage microbiome company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases.

BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets.


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