Phase 2 Trial of BX004, Phage Therapy for Bacterial Infections, Advancing

A Phase 2 clinical trial assessing the safety and efficacy of BX004 — BiomX’s phage therapy candidate for Pseudomonas aeruginosa infections in people with cystic fibrosis (CF) — remains on track to have results by the end of this year, the company announced.

While this timeline had been announced in a prior update, BiomX added that BX004 is now its selected investigational treatment for CF.

P. aeruginosa is the most common bacteria in lung infections and severe lung disease in people with CF. While antibiotics are usually the mainstay for such infections, certain bacteria develop ways of resisting standard antibiotics, making treatment difficult.

BiomX has developed a BOLT (BacteriOphage Lead to Treatment) platform that uses phages — viruses, or a virus cocktail, that can infect and kill bacterial cells — instead of antibiotics as bacteria-targeting therapies. BOLT was designed to rapidly develop phages (within six to eight weeks) targeting specific bacteria in a manner tailored to a given patient.

The process begins with isolating a person’s bacterial strain, followed by optimizing and producing the therapy for testing in clinical trials.

According to BiomX, studies conducted in the lab showed that BX004 is active against antibiotic-resistant strains of P. aeruginosa and can penetrate biofilm — slimy layers of microorganisms that stick to wet surfaces and protect bacteria from antibiotics and the host’s immune response.

Phage are “natural predators of bacteria,” and “specific to particular bacterial species or strains, targeting and killing them without disrupting other neighboring, potentially beneficial, bacteria,” the company states on its website.

“2020 was a tremendous year of growth for BiomX, as we expanded our pipeline with programs in cystic fibrosis and atopic dermatitis [eczema], both designed to address unmet medical needs,” said Jonathan Solomon, the company’s CEO.

BiomX reported in an April presentation that its Phase 2 proof-of-concept trial was testing BX004, as a nebulized therapy, against a placebo in up to 40 CF patients with chronic P. aeruginosa infections. Treatment would be given for seven to 10 days, with the efficacy of this phage combination evaluated through changes in bacterial counts, and measures of lung function and quality of life.

The company is also conducting clinical trials of phage-based treatment candidates for acne, inflammatory bowel disease, and primary sclerosing cholangitis.