Ruthigen, a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, has treated the first human subjects with its drug candidate RUT58-60 in a 30 patient, 21-day skin irritation trial, which is expected to be completed in August.
In June, Ruthigen's Investigational New Drug (IND) application became effective following review by the FDA. Ruthigen is developing RUT58-60 as a safe and fast acting, broad spectrum and potent anti-infective drug candidate intended to be used as an adjunct therapy to systemic antibiotics for the prevention and treatment of infection associated with abdominal surgery.
Hoji Alimi, chairman, CEO and chief scientific officer of Ruthigen, said, "Patients undergoing abdominal surgery should not have to worry about the risk of infections associated with their procedures. At Ruthigen we believe the key to optimizing patient care is to focus on the prevention of infections in the hospital and outpatient surgical settings."
Following an independent data monitoring committee review, the company plans to begin enrollment in a 150 patient, 28-day phase I/II clinical trial using RUT58-60 within the abdominal cavity. The phase I/II trial will be a controlled, double-blind, randomized, multi-centered study to evaluate the safety, tolerability and potential efficacy of RUT58-60.