All patients dosed with virus-based therapy for P. aeruginosa infections
BX004 was granted fast-track status by FDA in August
All the cystic fibrosis (CF) patients participating in the Phase 2 portion of a clinical trial have been dosed with BX004, an inhaled virus-based therapy for chronic Pseudomonas aeruginosa bacterial infections of the lungs.
Data from the first part of the Phase 1b/2a study (NCT05010577) showed the experimental therapy reduced the number of bacteria in the lungs with no signs of resistance. It was also tolerated well and there were no reports of side effects or discontinuations related to BX004.
“BX004 has been designed to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections,” Jonathan Solomon, BiomX’s CEO, said in the release. “With patient dosing now complete in Part 2 of our Phase 1b/2a study, we remain on track to announce results next month.”
The Part 1 findings were shared at two recent meetings — the European Cystic Fibrosis Society (ECFS) conference and the European Respiratory Society (ERS) Congress. Urania Rappo, MD, senior director of clinical development at BiomX, also presented part 1 data at the IDWeek 2023 meeting in Boston, Massachusetts.
“I am also pleased to note that our two late-breaker oral presentations highlighting our Part 1 results were well received by the CF community … further underscoring clinician and patient interest in the BX004 program,” Solomon said.
Effects of BX004 in first part of clinical trial
A hallmark feature of CF is thick mucus in the lungs, which can trap bacteria, lead to recurrent infections — particularly with P. aeruginosa — and impair lung function.
A combination of antibiotics is typically the first line of treatment to address these infections, but long-term use can lead to antibiotic resistance and reduced effectiveness.
Using its proprietary BOLT platform, BiomX developed BX004, a cocktail of antibacterial viruses, called phages, that target and kill P. aeruginosa. These viruses don’t infect human cells and may serve as alternatives to antibiotics in infections that are hard to treat.
The Phase 1/2 trial was launched to evaluate BX004’s safety and effectiveness in adults with CF and chronic P. aeruginosa lung infections after they received standard-of-care. In part 1, seven eligible participants (five men, two women) were randomly assigned to receive BX004. Two participants (one man, one woman) received a placebo.
The participants who received 15 days of BX004 had greater P. aeruginosa reduction in their lungs than those given a placebo. Because the same stains of P. aeruginosa bacteria were identified before and after treatment, no resistance to BX004 was noted.
For the trial’s second part, adults with CF and a hard to treat P. aeruginosa infection will receive BX004 or a placebo for 10 days.
The U.S. Food and Drug Administration granted the phage therapy fast-track status in August. The designation is intended to accelerate BX004’s development by granting it more access to the agency.