BiomX - Model BX004 - Cystic Fibrosis
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. Phase 1b/2a clinical study in CF patients is composed of two parts. Results from Part 1 aimed to evaluate the safety, pharmacokinetics, and microbiologic/clinical activity are expected in Q3 of 2022. Results from Part 2 aimed to demonstrate safety and efficacy are expected by Q1 of 2023.
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.
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.