29.11.2023 13:27:33

BiomX Announces Positive Results From Phase 1b/2a Study Of BX004 In Chronic Pulmonary Infections

(RTTNews) - BiomX Inc. (PHGE) Wednesday announced positive results from Part 2 of the Phase 1b/2a study of the company's investigational phage-based therapy BX004 for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.

Cystic fibrosis is a genetic disorder characterized by the buildup of thick, sticky mucus in organs.

In Part 2 of the Phase 1b/2a study, 34 cystic fibrosis patients were randomly selected to receive either BX004 or placebo. Results from the study showed clinically meaningful improvement in pulmonary function as measured in FEV1 (forced expiratory volume in 1 second) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in a predefined subgroup of patients with reduced lung function.

Further, at the end of 10 days, 14% of patients treated with BX004 converted to a negative P. aeruginosa sputum culture, compared with 0 in the placebo arm.

The company said it plans to advance BX004 program into pivotal Phase 2b/3 trial.

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