A total of 150 patients will be enrolled in the randomized, double-blind trial, which is designed to evaluate RUT58-60’s safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in patients undergoing abdominal surgery.
The first 20 patients in the trial will be evaluated initially for safety by a Data Monitoring Committee and will also be included in the total patient population for potential efficacy.
During the trial, patients will be divided into a control group that will receive the standard treatment of an intra-operative lavage with saline plus systemic antibiotics and a drug arm that will receive a RUT58-60 as an intra-operative lavage plus systemic antibiotics.
Ruthigen CEO and chief scientific officer Hoji Alimi said: "Our medical community, government and society are heightened to the risks associated with antibiotic resistance, hospital acquired infectious and other infectious diseases."
RUT58-60 is a broad-spectrum anti-infective drug candidate and the new chemical formulation includes hypochlorous acid (HOCl) with no hypochlorite, and uses other small molecule stabilizers.