Staphylococcus aureus Phage Product Candidate, AP-SA02
The three natural lytic phage that comprise our first-generation phage product candidate, AP-SA01, were chosen for their ability to cover approximately 95% of S. aureus clinical isolates, including multidrug-resistant strains. Human exposure obtained from two previously completed Phase 1 studies and through use under investigator Emergency IND, indicate that AP-SA01 is generally well-tolerated. AP-SA01 has advanced through a pre-IND meeting with the U.S. FDA.
Armata is developing a second-generation phage product candidate for S. aureus, known as AP-SA02, which offers significantly improved therapeutic attributes compared to AP-SA01.
Armata is committed to developing novel phage therapies that specifically address areas of high need which includes drug resistant and difficult to treat infections such as S. aureus bacteremia (SAB). We intend to file an IND Application with the U.S. FDA to initiate a Phase 1b/2, multi-center, randomized, double-blind, placebo-controlled dose escalation study that will assess the safety, tolerability, and efficacy of AP-SA02 administered intravenously as an adjunct to best available antibiotic therapy for the treatment of SAB. Armata’s goal is to obtain nondilutive financing to initiate this clinical study in S. aureus bacteremia in 2020.
Target Market and Medical Need
The Centers for Disease Control and Prevention estimates that up to 1.7 million people in the U.S. develop bacteremia each year. It is estimated that one in three patients who die in the hospital have bacteremia. Bacteremia is the most expensive condition treated at U.S. hospitals, costing approximately $24 billion annually. S. aureus is the second most common pathogen associated with bacteremia, causing approximately 200,000 hospitalizations each year in the U.S. Despite conventional antibiotics, mortality in SAB results in death of up to 40% of all cases and 57% of patients over the age of 85. Patients with comorbidities such as alcoholism, malignancy, diabetes, end-stage renal disease requiring hemodialysis, and immunosuppression are at even higher risk for death when SAB develops. Age-adjusted mortality assessments show that SAB mortality is higher than that of AIDS, tuberculosis, or viral hepatitis, and comparable to mortality rates for breast or prostate cancer. Outcomes are even poorer for SAB due to MRSA, classified as a serious threat to global health by the CDC and a high priority threat by the WHO, with higher rates of complications and increased mortality as compared to MSSA.