A combination of Salvecin (AR-301) and antibiotics eradicated ventilator-associated bacterial pneumonia (VABP) better than antibiotics alone, according to a Phase 2a clinical trial.
In addition, patients treated with the combo were able to use a ventilator less than those receiving antibiotics only, researchers said.
Salvecin’s developer, Aridis Pharmaceuticals, presented the trial results at the American Society for Microbiology Congress in New Orleans, June 1-5. They covered the combo’s effectiveness against hospital-acquired bacterial pneumonia, or HABP, as well as VABP.
The trial dealt with the effectiveness and safety of Salvecin as an adjunctive, or add-on, therapy against severe pneumonia caused by the Staphylococcus aureus bacteria.
Salvecin is a human monoclonal antibody that targets the alpha-toxin that S. aureus releases when it infects someone. Salvecin’s action is independent of the bacteria’s resistance to antibiotics. That means it can counter infections caused by methicillin‐resistant S. aureus and methicillin‐sensitive S. aureus.
Aridis is developing Salvecin as an add-on to standard-of-care antibiotics for both HABP and VABP. In preclinical-trial animal studies, it reduced bacteria and significantly improved survival rates.
The Phase 2a trial (NCT01589185) was a randomized, double-blind, placebo-controlled, first-in-human study. It was designed to assess the effectiveness, safety and pharmacokinetics of Salvecin as an adjunct therapy for S. aureus-related pneumonia. Pharmacokinetics refers to the body’s effect on a drug,
Researchers enrolled 48 patients at 13 intensive care units in the United States, the United Kingdom, France, Spain, and other countries.
Eradication of S. aureus was higher in the combo group than in the placebo group. And VABP patients who received the Salvecin-antibiotics combo spent less time under ventilation at all dose levels tested than a placebo group that received antibiotics only.
In terms of safety, HABP patients who received the Salvecin combo experienced no serious adverse events at any dose level. In addition, there was no difference in adverse events between the combo group and the control group.
“Hospital-acquired bacterial pneumonia (HABP) due to S. aureus affects more than 500,000 patients a year in the U.S., Europe, and Japan,” Dr. Vu Truong, Aridis’ chief executive officer, said in a press release. “In addition to finding Salvecin safe and tolerable, encouraging efficacy indicators were observed. We believe our approach will help significantly improve the clinical course of patients with HABP.
“Advancing this new, antibody-based immunotherapy towards late-stage clinical studies in the coming months is a priority for Aridis, especially in these times of emerging multi-drug resistant S. aureus,” Truong said. “This innovative and potentially breakthrough treatment may represent a much-needed therapeutic advance for patients hospitalized in an ICU [intensive care unit] with S. aureus pneumonia.”