The US Food and Drug Administration (FDA) has cleared Ruthigen Inc's Investigational New Drug (IND) application without a clinical hold to begin human clinical testing of RUT58-60.
Ruthigen expects to enroll its first patient in July 2014 and complete a 30 patient, 21-day skin irritation trial in August 2014. Following an independent data monitoring committee review, the company plans to enroll 20 patients, as part of the phase 1/2 trial, to evaluate the safety of the product within the abdominal cavity. The phase I/II trial will be a controlled, double blind, randomized, and multi-centered study to evaluate the safety, tolerability, and efficacy of RUT58-60 as an adjunct therapy to systemic antibiotics for the prevention of infection associated with abdominal surgery.
The company expects to enroll a total of 150 patients to complete the phase 1/2 trial. The initial 20 patient safety portion of the phase 1/2 trial is expected to be completed in Q4 2014. The trial will remain blinded; however, the safety results for the initial 20 patients will be reviewed by the data monitoring committee. The company plans to continue the enrollment of the remaining 130 patients in the clinical trial, subject to confirmation by the data monitoring committee of no significant adverse events. Ruthigen expects to complete the phase 1/2 trial in Q1 2015.
Hoji Alimi, chairman, CEO and CSO of Ruthigen, said: "We are excited to be in position to begin the clinical development of RUT58-60. Unlike the most commonly prescribed antibiotics, RUT58-60 is a broad and fast acting anti-infective with in vitro efficacy data against gram-positive and gram-negative bacteria including antibiotic resistant strains such as MRSA. RUT58-60 has a novel mechanism of action to prevent emergence of bacterial resistance and improves patient safety by neither targeting specific bacterial cell membrane receptors nor exposing patient's vital organs to unnecessary systemic drugs."
RUT58-60 is a new chemical formulation containing hypochlorous acid, HOCl, with no hypochlorite, and utilizes other small molecule stabilizers. RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use during invasive surgical procedures. The drug has been shown in laboratory tests to eradicate both gram-positive and gram-negative bacteria, including antibiotic resistant bacteria within the first 30 seconds of contact. RUT58-60 was designed to improve patient lives, redefine infection control in surgical procedures and deliver cost savings to hospitals. The company's clinical program targets an initial $700 million potential market in the prevention of infections associated with abdominal surgery.
Ruthigen is a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications.