Our Pipeline

Customized phage therapies to eradicate
harmful bacteria in chronic diseases

Phage Discovery
Phase I
Phase II
Phase III
Cystic Fibrosis BX004 Phase II

Product Candidate Overview

We are developing BX004, a phage therapy for CF patients with chronic Pseudomonas aeruginosa (P. aeruginosa) respiratory infections, a main contributor to morbidity and mortality in this disease. On November 2023 we announced positive topline results from Part 2 of a Phase 1b/2a trial evaluating BX004 for treatment of chronic pulmonary infections in patients with CF. Under the study BX004 showed clinically meaningful improvement in pulmonary function as measured in FEV[1] and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain in patients with reduced lung function (baseline FEV1<70%).

[1] FEV1 (or ppFEV1) – percent predicted forced expiratory volume in 1 second. CFU – colony-forming units

Unmet Need

There are an estimated 30,000 CF patients in the US and 80,000 worldwide. The launch of new medications such as Trikafta and Symdeko, have improved the quality of life for CF patients; however, chronic, antibiotic resistant bacterial infection remains a main contributor to morbidity and mortality. P. aeruginosa is the most common and detrimental bacteria in lung infections of CF patients and it is estimated that approximately 30-50% of these patients suffer from chronic infections due to this bacterium.

Mode of Action

Chronic P. aeruginosa infection leads to epithelial surface damage and airway plugging, progressively impairing pulmonary function. CF patients chronically infected by P. aeruginosa show a steeper lung function decline, a higher number of pulmonary exacerbations, more hospital admissions and higher mortality than P. aeruginosa -free patients. P. aeruginosa infections usually start in childhood and following prolonged and repeated broad-spectrum antibiotic courses, enhanced resistance to antibiotics develops and leads to the appearance of multidrug-resistant (MDR) strains. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of P. aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance and one of the leading causes for antibiotic resistance.

Diabetic Foot Osteomyelitis BX211 Phase II

Product Candidate Overview

We are developing BX211, a personalized phage treatment, for patients with Diabetic Foot Osteomyelitis (DFO)associated with Staphylococcus aureus (S. Aureus). DFO is a bacterial infection of the bone that usually develops from an infected foot ulcer and is a leading cause of amputation in patients with diabetes. We have an ongoing randomized, double-blind, placebo-controlled, multi-center phase 2 study investigating the safety, tolerability, and efficacy of BX211 in subjects with DFO associated with S. aureus. Study topline results are expected in Q1/2025.

Unmet Need

There are more than 1.5 million patients diagnosed with diabetes worldwide each year. DFO results from soft tissue infections in diabetic patients where the infection spreads into the bone and is the cause of approximately 85% of lower extremity amputations in diabetic patients. The American Diabetes Association estimates that 20% of patients with diabetic foot infections, of which more than 60% have severe infections, have underlying osteomyelitis that left unresolved, places patients at significantly higher risk of amputation.

Mode of Action

Traditional antibiotic approaches lose effectiveness in treatment of DFOs over time due to bacteria’s inherent ability to evolve resistance and the development of biofilm. Compassionate treatment cases using phage, by us and others, in DFO and osteomyelitis have shown initial promising results. Our approach uniquely leverages an ever-growing library of systematically discovered, selected, catalogued, and curated phages, which collectively provide broad coverage against many of the world’s highest priority antibiotic-resistant bacteria. Phages from the our PhageBank are precision-matched to the patient’s infections through a proprietary phage susceptibility test (PST).

Our Partners

biomx’s corporate presentation

Updated April 2024

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