The investigational treatment is being developed for this patient population.
The emergence of bacteriophage (phage) therapy for In the United States, phage is only available in compassionate use scenarios, so there is an unmet need.
Israel-based BiomX has developed its BX004-A, an investigational phage therapy, that is being studied for treatment of chronic Pseudomonas pulmonary infections in CF patients.
The results indicated that BX004-A was well-tolerated and showed notable microbiologic efficacy in reducing PsA colony counts in sputum samples.
Eastern Bloc countries and the Soviet Union use bacteriophage (phage) therapy for bacterial infections. In the United States, phage is only available in compassionate use scenarios, so there is a whole process people have to go through in order for patients to gain access to phage therapy. Nonetheless, biopharmaceutical companies are beginning to develop phage therapies and the emergence of studies are beginning to appear.
For patients with cystic fibrosis (CF), they can often battle Pseudomonas aeruginosa (PsA), which can be especially troublesome for this patient population. This pathogen can colonize in the lungs of people with CF, and is often something that can kill these patients, especially if antibiotics prove to be ineffective.
Israel-based BiomX has developed its BX004-A, an investigational phage therapy, that is being studied for treatment of chronic Pseudomonas pulmonary infections in CF patients.
They conducted a study that is being presented as a late-breaking abstract at
Investigators performed a phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study looking at the safety and tolerability of nebulized phage (BX004-A) and its effect on sputum PsA burden and clinical outcomes.
“In Part 1, 9 subjects were randomized (7 on BX004-A, 2 on placebo), with a mean baseline PsA burden of 7.4 (range 4.2-8.5) and 7.9 (range 7.8-8.0) log10 colony forming unit (CFU)/g in BX004-A vs placebo, respectively. One subject in each arm had a multi-drug resistant PsA and 1 subject in each arm had an extensively drug-resistant PsA. Mean PsA CFU reduction at D15 (compared to baseline) was -1.42 log (BX004-A) vs. -0.28 log (placebo),” investigators wrote.
“Part 1 showed that BX004-A was well-tolerated with notable microbiologic efficacy. All Part 1 subjects had high levels of Screening PsA with all morphotypes susceptible to the phage cocktail,”
In a
“These patients are taking a ton of antibiotics just to keep the bacteria at bay and are slowly deteriorating,” Solomon said. “Now, it is quite horrendous because these patients basically, you know, if their lung function deteriorates many times, they are not even eligible for lung transplants because they have a drug resistant bacteria that can emerge anytime.”
BiomX is committed to getting their investigational therapy through clinical trials and they see a potential path toward regulatory FDA approval.
REFERENCE
Rappo U, Cohen A, et al. Nebulized Phage Therapy for Patients with Cystic Fibrosis with Chronic Pseudomonas aeruginosa Pulmonary Infection: A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Study. Presented at: IDWeek 2023. October 11-14, 2023; Boston, MA. Abstract 2891.
