Dosing Begins in Phase 1/2 Trial of BX004 for P. aeruginosa Infections

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by Patricia Inácio, PhD |

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Two patients have been dosed in a clinical trial testing BX004, a nebulized phage therapy designed to kill Pseudomonas aeruginosa, the most common cause of lung infections in people with cystic fibrosis (CF).

The Phase 1b/2a trial (NCT05010577), which is funded by the Cystic Fibrosis Foundation and underway in the U.S. and Israel, will determine how safe and effective BX004 is in adult CF patients with chronic P. aeruginosa infections.

“We are pleased to reach this important clinical milestone in our cystic fibrosis program,” Jonathan Solomon, CEO of BiomX, the company developing the therapy, said in a press release.

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P. aeruginosa is a bacterium commonly found in lung infections of people with CF. Most importantly, the bacterium can undergo changes that enable it to become resistant to antibiotics, leading to a decline in lung function and worse health outcomes.

The use of bacteriophage (phage) therapies — viruses that kill particular strains of bacteria without harming beneficial bacteria or human cells — offers a potential alternative to the current problem of antibiotic-resistant bacteria.

BX004 comprises a phage mixture or cocktail designed to target P. aeruginosa strains.

“Despite the significant advancements made in the treatment of cystic fibrosis, Paeruginosa remains a leading cause of patients’ morbidity and mortality. The treatment options for patients suffering from antibiotic resistant strains are limited,” said Eitan Kerem, MD, professor of pediatrics and former chairman of the Department of Pediatrics and the Pediatric Pulmonology Unit of the Hadassah University Medical Center in Jerusalem.

“New and innovative treatment approaches such as the one potentially provided by BX004 are therefore urgently needed to address this significant unmet medical need,” Kerem added.

In lab tests, BX004 was able to kill antibiotic-resistant strains of P. aeruginosa and showed greater ability to penetrate biofilms — a mesh that bacteria grow to protect them from substances that might harm them — than antibiotics.

BX004’s clinical development follows promising results from a U.S. compassionate program with phage therapy in CF patients. Phage therapy lessened the bacterial burden and boosted lung function, Kerem said.

This provides “further rationale for pursuing this approach,” he added. “I look forward to seeing the results from this important study in the near future.”

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The Phase 1b/2a will be conducted in two parts. In part one, a total of eight patients will receive single ascending and multiple doses of BX004. The aim is to assess the therapy’s safety, pharmacokinetics, and clinical activity. Pharmacokinetics refers to the movement of a medicine into, through, and out of the body.

Results from this part are expected by September.

In part two, researchers will assess BX004’s safety and efficacy compared to a placebo. In total, 24 adults with CF will be randomly assigned to either group.

Results are expected in the first quarter of 2023.