CFF Supporting Phase 1/2 Trial of Phage Therapy for P. aeruginosa Infections

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by Lindsey Shapiro PhD |

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BiomX has been given up to $5 million to support a clinical trial of BX004, a phage therapy to fight Pseudomonas aeruginosa infections in people with cystic fibrosis (CF).

Trial funding, awarded by the Cystic Fibrosis Foundation (CFF), marks one of several recent studies into phage therapy conducted with foundation support.

“Although promising results have been reported in several individual cases, studies like this one will help us evaluate the safety and efficacy of phage as a potential therapy,” JP Clancy, MD, vice president of clinical research for the CFF, said in a press release.

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P. aeruginosa is a bacterium that commonly causes lung infections in people with CF. Many patients also develop drug-resistant P. aeruginosa infections that do not respond to the standard antibiotic treatment. 

“Developing new approaches to treat drug-resistant bacteria is critical as many people with CF struggle with difficult-to-treat infections,” Clancy said.

As an alternative to antibiotics against P. aeruginosa infections, BiomX has been working on the development of bacteriophage (phage) therapies. Phages are viruses that kill particular strains of bacteria without harming or destroying beneficial bacteria or human cells. BX004, its phage mixture or cocktail, is designed to specifically target P. aeruginosa strains.

In lab experiments conducted by BiomX, BX004 killed antibiotic-resistant strains of P. aeruginosa, even in the presence of biofilm — a mesh that bacteria grow to protect them from substances that might harm them, including antibiotics.

The Phase 1b/2a clinical trial (NCT05010577) will determine how safe and effective BX004 is in up to 32 adult CF patients with chronic P. aeruginosa infections. This study, taking place in the U.S. and Israel, may still be enrolling eligible patients; contact information is available here.

It will be conducted in two parts. The goal of part one is to assess the safety of inhaled BX004, at single ascending and multiple doses, in eight patients. Researchers will also evaluate how the body responds to and metabolizes different doses of BX004. Results from this trial part are expected by the close of June.

In part two, BX004’s safety will be evaluated in 24 adults, who will receive either the nebulized therapy or a placebo. Researchers will also examine how well BX004 clears P. aeruginosa from the sputum, or mucus and saliva coming from the respiratory tract. Timing is not yet known for the release of results here. 

The investment comes as part of the CFF’s Infection Research Initiative, which between 2019 and 2023 is giving at least $100 million to support research focused on  CF infections. 

“We are very pleased to receive the support of the Cystic Fibrosis Foundation,” said Jonathan Solomon, CEO of BiomX, in a company press release. “We look forward to reporting data from our Phase 1a/2b trial in 2022.”


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