Ruthigen Inc., a biopharmaceutical company focused on improving patient outcomes and reducing healthcare costs in invasive procedures, has announced that its lead drug candidate, RUT58-60, has received a recommendation from the Data Monitoring Committee (DMC) to begin enrolling patients in the company's planned phase 1/2 clinical trial.

RUT58-60 is intended for use as an adjunct therapy in combination with prophylactic systemic antibiotics to prevent infections in abdominal surgical procedures. RUT58-60 is designed to improve patient outcomes, cut costs associated with hospital-acquired infections and reduce the emergence of harmful antibiotic-resistant bacteria. Because it can be used in a lavage -- a commonly performed cleansing procedure in invasive surgery -- it has the advantage of requiring no disruptions to surgeon or hospital procedures.

The DMC's recommendation followed a review of data from Ruthigen's first human clinical study of RUT58-60, a 21-day skin irritation study on 36 healthy subjects, which was completed in August 2014. The DMC's recommendation along with the incorporation of comments from FDA's previously completed IND review allows Ruthigen to proceed to the next phase of its clinical plan: a controlled, randomized, double-blind and multi-centered trial in which it expects to begin enrolling patients in September 2014.

"We are very excited to begin patient enrollment in our combined phase 1/2 human clinical trial of RUT58-60," said Hoji Alimi, Ruthigen's CEO and chief scientific officer. "Our team has been right on track in meeting the milestones of our clinical development program. If all goes according to plan, we expect to begin preparations for our first US pivotal trial in mid to late 2015."

Ruthigen plans to enroll 150 patients in the phase 1/2 trial, which will evaluate RUT58-60's safety, tolerability and potential efficacy for use as an adjunct to systemic antibiotics in abdominal surgery. Initially, the company will enroll 20 patients, who will be divided into a control group that will receive the standard treatment of a saline lavage and systemic antibiotics and a drug arm that will receive a RUT58-60 lavage and systemic antibiotics.

Ruthigen expects to complete the initial 20-patient safety portion of the trial in late 2014. Once the DMC has reviewed the safety results and issued its recommendation to proceed, Ruthigen will continue with the enrollment of the remaining 130 patients. The Company expects to complete the phase 1/2 trial in late first quarter of 2015.

"We believe RUT58-60 has great potential for reducing infection in all types of invasive surgery," Alimi said. "We are beginning with abdominal surgery because it represents such a huge unmet need. Ultimately we plan to develop formulations of RUT58-60 for use in orthopedic, cardiovascular, spinal and other types of invasive surgery."

Unlike most commonly prescribed antibiotics, RUT58-60 is a broad and fast-acting anti-infective that has been demonstrated in-vitro to be effective against gram-positive and gram-negative bacteria, including antibiotic-resistant strains such as MRSA. The investigational drug, which is designed for prophylactic use to prevent infections in surgical and trauma procedures, is believed to work by mimicking the body's natural microbe-fighting mechanisms.

RUT58-60 is also expected to help keep healthcare costs down by reducing hospital readmission rates due to reinfection. Under the Affordable Care Act, hospitals are subject to financial penalties for patient readmissions. The drug also helps reduce healthcare costs by preventing infection in general, which leads to shorter stays and reduced costs for antibiotic treatment and isolation measures.  

Another important advantage of RUT58-60 is that it may significantly reduce the potential for the emergence of "superbugs" by reducing the use of antibiotics, the overuse of which contributes to the emergence of antibiotic-resistant bacteria. Also, because its novel mechanism of action does not target membrane proteins, it does not promote the mutations that lead to the development of antibiotic resistance.

RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use to prevent infections during invasive surgical procedures. The new chemical formulation contains hypochlorous acid (HOCl) with no hypochlorite, and utilizes other small molecule stabilizers. The drug candidate 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, with the market for the prevention of infections associated with all types of surgery being estimated at $3 billion.