Safety of Phage Therapy Evident in Cystic Fibrosis Patients With Persistent Pseudomonas aeruginosa Infection

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BiomX Develops BX004-A, a Phage Therapy, for Cystic Fibrosis Patients with Pseudomonas Infections. A phase 1b/2a study presents promising results at IDWeek 2023.

(This version of this article first appeared on our sister brand, ContagionLive.com®.)

3d rendered medically accurate illustration of the bronchi    (Adobe Stock 282270645 By SciePro)

3d rendered medically accurate illustration of the bronchi

(Adobe Stock 282270645 By SciePro)

Bacteriophage therapy, also known as phage therapy, is primarily used in Eastern Bloc nations and the Russian Federation to combat bacterial infections. However, in the United States, phage therapy is only available through compassionate use scenarios involving a complex process. Despite this, biopharmaceutical companies are now beginning to develop phage therapies, and research studies on the efficacy of phage therapy are also starting to emerge.

Patients afflicted with cystic fibrosis (CF) can often fight Pseudomonas aeruginosa (PsA)which can be especially troublesome for this patient population. This pathogen can colonize in the lungs of people with CF and can be life-threatening, especially if antibiotics prove ineffective.

Israel-based BiomX has developed its BX004-A, an investigational phage therapy focusing on chronic Pseudomonas pulmonary infections in CF patients.

What You Should Know

BiomX, an Israel-based company, has developed an investigational phage therapy called BX004-A. The therapy is being studied for treating chronic Pseudomonas pulmonary infections in patients with cystic fibrosis.

The study, presented at IDWeek 2023, results indicate that BX004-A was well-tolerated and exhibited notable microbiologic efficacy in lowering PsA colony counts in sputum samples.

Investigators performed a phase 1b/2a randomized, double-blind, placebo-controlled, multicenter study. This study is presented as a late-breaking abstract at IDWeek 2023, held in Boston, Massachusetts, from October 11 to 15, 2023. The study assessed the safety and tolerability of nebulized phage ((BX004-A) and its effect on sputum PsA burden and clinical outcomes. According to investigators, Part 1 of the study revealed that BX004-A demonstrated good tolerability and remarkable microbiological effectiveness.

“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 previous interview with Infection Control Today®’s sister brand, Contagion, BiomX CEO Jonathan Solomon said his company wants to address the unmet need for people with CF. “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 dedicated to advancing its investigational therapy through clinical trials and is actively exploring a potential path toward regulatory FDA approval.

Click here for more coverage of IDWeek 2023.

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.

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