Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AR-301, also referred to as Salvecin™, the company's fully human anti-Staphylococcal α-toxin IgG1 monoclonal antibody being developed for the treatment of hospital-acquired and ventilator-associated pneumonia (HAP and VAP) caused by Staphylococcus aureus, including multi-drug resistant 'MRSA' strains. Acceptance of the IND application enables Aridis to expand and accelerate its current Phase 2a study of AR-301 as an adjunctive therapy with standard-of-care antibiotics into the United States. The study is currently underway in three European countries, with further expansion into the United Kingdom also planned. Top-line results from the accelerated Phase 2a study are expected in the first half of 2016.
Paul-Andre de Lame, M.D., Chief Medical Officer of Aridis, stated, "We are looking forward to expanding the Phase 2a trial of AR-301, our second most advanced product candidate, into the United States. We believe AR-301 can positively impact the outcome of S. aureus infections by improving survival rates and/or shortening the time a patient spends in the intensive care unit (ICU), or overall hospital stay."
Vu Truong, Ph.D., founder and Chief Executive Officer, added, "This is important because we believe it could potentially save thousands of lives per year and significantly reduce hospital infrastructure-related costs. We look forward to completing this study and reporting top-line results in the first half of 2016."
The European Phase 2a clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous administration of AR-301 in patients with severe pneumonia caused by S. aureus. Depending on the outcome of Phase 2a clinical trial, Aridis expects the subsequent phase of clinical testing of AR-301 to be either a Phase 2b trial, followed by a Phase 3 trial in pneumonia patients.
AR-301 was discovered by screening B-cell lymphocytes of a patient with confirmed S. aureus infection and developed using Aridis' proprietary MAbIgX® technology. It binds and neutralizes S. aureus alpha toxin, preventing alpha toxin-mediated destruction of human cells. There is no anti-infective on the market that specifically neutralizes the pathogenic affects brought about by S. aureus toxins and Aridis believes that this mechanism of action complements the bacterial killing properties of many conventional antibiotics, as the bacterial toxins left behind following antibiotic-mediated killing can still be neutralized by AR-301.
Aridis Pharmaceuticals, Inc.