Customized phage therapies to eradicate
harmful bacteria in chronic diseases
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. Phase 1b/2a clinical study in CF patients is composed of two parts. We announced positive results from Part 1 of the study aimed to evaluate the safety, pharmacokinetics, and microbiologic/clinical in Q1 of 2023. Results from Part 2 aimed to demonstrate safety and efficacy are expected by Q3 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.
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.
Product Candidate Overview
We are developing BX005, a topical phage cocktail that targets Staphylococcus aureus (S. aureus), a bacteria associated with the manifestation of the disease. This program leverages know-how and capabilities acquired under our previous programs with regard to topical formulation and clinical testing. In preclinical in vitro studies, BX005 was shown to be active against over 90% of strains of S. aureus isolated from the skin of subjects from U.S. and Europe, including antibiotic resistant strains.
Companies active in the dermatology space are aware of the enormous patient potential in the AD market. The approval of Dupixent has transformed the treatment of AD and has addressed the unmet need of treating severe refractory patients. Nevertheless, systemic treatments have multiple side effects and there remains an enormous opportunity in the topical treatment arena for patients who are not candidates for systemic therapies, including patients suffering from mild to moderate disease and pediatric patients whose parents are particularly wary of the safety aspects of treatment and are seeking safe and natural alternatives.
Mode of Action
The relationship between AD and skin bacteria has led to different anti-microbial treatment approaches including the use of bleach baths. On the background of predisposing factors, Staphylococcus aureus (S. aureus) is thought to contribute to development and exacerbation of inflammation in AD skin through release of various virulence factors that affect both keratinocytes and immune cells. S. aureus is more abundant on the skin of AD patients than non-AD individuals and in lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when patients experience flares. By reducing the load of S. aureus, our phage therapy is intended to shift the skin microbiome composition to its ‘pre-flare’ state and provide a clinical benefit.
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