CFF puts $5M more into BiomX for trial of BX004 for lung infections

Funding will support Phase 2b study of therapy for P. aeruginosa infections

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The Cystic Fibrosis Foundation (CFF) has invested another $5 million into BiomX, which will help fund a Phase 2b clinical trial of BX004 — a phage therapy the company is developing to clear up lung infections in cystic fibrosis (CF) caused by the Pseudomonas aeruginosa bacteria.

In 2022, the foundation put about $5 million into the company to support a Phase 1b/2a study testing how safe and well tolerated BX004 is in CF patients with chronic lung infections caused by the bacteria, known for short as P. aeruginosa.

The Phase 2b trial is planned for a launch later this year, with data anticipated in the third quarter of 2025. The study will enroll about 60 CF patients who will be randomly assigned to receive either BX004 or a placebo twice daily for eight weeks, or nearly two months.

In CF, the disease’s hallmark thick mucus provides fertile ground for P. aeruginosa and other harmful bacteria in the airways, leading to chronic infections that often become resistant to antibiotics. Phages are viruses that kill the bacteria they infect, which may be an option for antibiotic-resistant infections.

“We continue to look for innovative ways to treat chronic and drug-resistant infections in people with CF,” Tiffany Burnett, senior director of biopharma programs at the CFF, said in a foundation press release.

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According to data from 2022, 1 in 4 patients in the CFF Patient Registry tested positive for Pseudomonas bacteria. More than 10% of those patients had strains of bacteria that were resistant to multiple antibiotics.

BiomX created BX004 as a so-called phage cocktail that could target a broad range of P. aeruginosa strains. It is inhaled into the lungs using a nebulizer.

These types of trials are important as we seek to … determine whether phage therapy is a viable treatment option for the broader CF population.

The new clinical study seeks to determine the cocktail’s efficacy.

“These types of trials are important as we seek to move past individual reports of success to determine whether phage therapy is a viable treatment option for the broader CF population,” Burnett said.

Top-line data from the Phase 1b/2a clinical trial (NCT05010577) showed that BX004 outperformed a placebo in improving lung function. It also reduced the number of P. aeruginosa bacteria in the airways without triggering resistance. Additionally, BX004 was safe and well tolerated.

Besides further testing BX004’s safety and tolerability, the planned Phase 2b clinical trial will evaluate how well the phage therapy reduces P. aeruginosa bacteria load or improves clinical parameters such as lung function and patient-reported outcomes.

Phage therapy is not approved in the U.S. Right now, CF patients in the country can access phage therapy only by joining a clinical trial or getting special permission from the U.S. Food and Drug Administration to use an experimental therapy for life-threatening situations.