07 Jan Aridis Pharmaceuticals Reports Positive Phase 1 Clinical Results for Aerucin® for Treating Hospital-Acquired and Ventilator-Associated Pneumonia
SAN JOSE, Calif. – January 7, 2016 – Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel anti-infectives and immunotherapies for infectious diseases, announced today positive Phase 1 clinical results for its fully human monoclonal antibody Aerucin® for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Gram negative bacteria Pseudomonas aeruginosa.
The completed first-in-human clinical study demonstrated Aerucin’s safety at all dose levels tested, showing no serious adverse events and only low-grade adverse events that were not deemed to be drug related. The study enrolled a total of 16 healthy volunteers who were assigned to one of three cohorts, each receiving an increasing dose of Aerucin® up to 20mg/kg. Participants were observed for a period of 84 days.
Vu Truong, Ph.D., Founder and CEO of Aridis, stated, “Once again we have demonstrated the strong safety profile of our anti-infective human monoclonal antibody platform. We are encouraged by these results and are eager to advance Aerucin further into the clinic, where we expect to eventually demonstrate its best-in-class reactivity against P. aeruginosa bacteria, including antibiotic resistant strains”. Preparation of Phase 2 clinical trial in acute pneumonia patients is underway, including the manufacturing of clinical drug supplies to support an international trial later this year.
Aerucin® is a fully human monoclonal IgG1 antibody that binds to alginate, a widely distributed cell surface polysaccharide on P. aeruginosa, and enhances complement deposition, leading to improved immune recognition and phagocytic destruction of P. aeruginosa by the immune system. Aerucin was shown to bind greater than 90% of clinical isolates of P. aeruginosa. The product is being developed initially as an adjunctive anti-infective to treat hospital-acquired and ventilator-associated pneumonia due to P. aeruginosa. Development of this product candidate has been supported extensively by funding from the National Institutes of Health, or NIH, during pre-clinical development through IND filing, as well as clinical manufacturing of drug product for a planned Phase 2 trial.
About Acute Pneumonia Due to Pseudomonas aeruginosa
Pseudomonas infection is caused by strains of bacteria found widely in the environment. Pseudomonas aeruginosa, or P. aeruginosa, is a Gram negative bacterium that causes a variety of infections in humans, and is particularly prevalent and lethal in pneumonia. Drugs targeting Gram- negative bacteria must cross both the inner and outer membranes of the bacterial cell, as compared to those directed against Gram-positive bacteria, which must only cross one cell membrane. As a result, Gram-negative bacteria tend to be more resistant to antibiotics and the body’s own immune system. Serious infections usually occur in hospitalized patients and/or those with a compromised immune system. Patients in hospitals, especially those on ventilators, catheters, and with wounds from surgery are potentially at risk for serious, life-threatening infections. Typically treated with antibiotics, P. aeruginosa infections are more difficult to cure in hospitals due to increased antibiotic resistance. According to the Center for Disease Control and Prevention, or CDC, an estimated 51,000 healthcare-associated P. aeruginosa infections occur in the U.S. each year.
About Aridis Pharmaceuticals, Inc.
Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies. Aridis’ product pipeline includes AR-101 anti-Pseudomonas aeruginosa LPS human monoclonal antibody ‘Aerumab®’; AR-301 anti-Staphylococcus aureus human monoclonal antibody ‘Salvecin®’ to treat acute pneumonia; Aerucin®, a broadly reactive anti- Pseudomonas aeruginosa human monoclonal antibody initially being developed to treat acute pneumonia; Panaecin®, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of Arumab® (AR-101), Salvecin® (AR-301), Aerucin®, Panaecin®, AR-401, AR-201, Aridis’ proprietary formulation and delivery technologies, about Aridis’ strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis’ expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis’ research and clinical studies and its ability to obtain additional financing. These forward-looking statements represent Aridis’ judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements.
Joshua Drumm, Ph.D. (investors)
Andrew Mielach (media)