BX004 on fast track to treat P. aeruginosa infections

FDA grants designation to BX004 to treat the bacterial infection common in CF

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has granted fast track designation to BX004, a virus-based therapy that BiomX is developing to treat Pseudomonas aeruginosa bacterial infections in people with cystic fibrosis (CF).

The FDA gives this designation to therapies that are designed to address unmet medical needs in the treatment of serious conditions. The designation gives BiomX access to earlier and more-frequent communications with the FDA throughout the drug development process, with the aim of bringing needed medicines to market faster.

“Our BX004 clinical program in cystic fibrosis … continues to build significant momentum,” Jonathan Solomon, CEO of BiomX, said in a press release.

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Solomon added that the FDA’s decision to award fast track designation “provides further recognition that our BX004 program is addressing one of the most serious and challenging unmet medical needs facing the CF community.”

People with CF are at increased risk from bacterial lung infections, and P. aeruginosa is one of the main types of bacteria that causes problematic infections in CF patients. BX004 contains a cocktail of bacteriophages — viruses that can kill bacteria — that is formulated to destroy P. aeruginosa. The therapy is delivered into the lungs via a nebulizer.

BiomX is currently sponsoring a Phase 1b/2a clinical trial (NCT05010577) testing BX004 against a placebo in people with CF who have chronic infections with P. aeruginosa.

Earlier this year the company presented data from the first part of the trial, in which seven people with CF were given single ascending doses of BX004 for three days, then multiple doses of the therapy for four days. Another two participants were given a placebo.

Significant reduction in P. aeruginosa

Results showed there were no side effects associated with BX004 and, after about two weeks of treatment, BX004 led a more than more than 90% reduction in P. aeruginosa compared to placebo. These data, which also were presented in June at the European Cystic Fibrosis Conference, “highlighted the excellent safety of BX004 along with its notable activity in reducing P. aeruginosa bacteria burden,” Solomon said.

BiomX is now working on the second part of the trial, which will test a longer duration of treatment with BX004 in more patients. Results from the second part of the study are expected later this year.

“In Part 2, we are testing BX004 in a larger number of CF patients who are dosed twice a day and over a longer, 10-day treatment period compared to Part 1,” Solomon said, adding that the second part of the study “will provide additional data on safety and reduction in bacterial burden, along with other exploratory clinical endpoints.”

The company already has completed screening of patients for the second part, and is expecting the study eventually will include more patients than originally planned.

“We recently completed patient screening in Part 2 of our ongoing Phase 1b/2a trial with patient enrollment expected to exceed original estimates, which reflects continued execution by our clinical team and a growing awareness within the CF patient community of the BX004 program,” Solomon said.

“Based on our current estimates, we now believe the Part 2 data analysis will take an additional 4-6 weeks to complete. We therefore expect to report initial results from Part 2 in November 2023,” he added.