Ruthigen Doses First Patient In RUT58-60 Anti-Infective Trial
By Cyndi Root
Ruthigen has begun a twenty-one day trial of RUT58-60, an anti-infective. The company announced in June that the Food and Drug Administration (FDA) had cleared this trial that would include 30 patients and that is expected to be complete in August 2014. Ruthigen is investigating the novel agent in combination with systemic antibiotics for the prevention of abdominal surgery infections. Ruthigen is a year and a half old company, a wholly-owned subsidiary of Oculus Innovative Sciences, and it intends to spin-off from Oculus and conduct drug discovery. RUT58-60 is its first candidate to enter clinical trials.
Hoji Alimi, Chairman, CEO, and CSO of Ruthigen, said, "Treatment of our first subject with RUT58-60 is an important milestone and marks a transition for Ruthigen into a clinical-stage company."
RUT58-60
Oculus announced in a press release in February 2014 that Ruthigen and Oculus would separate into two companies and Ruthigen would obtain the exclusive rights to develop and commercialize RUT58-60. The investigational drug is a hypochlorous acid-based solution. It contains small molecule stabilizers and has two to four times the concentration of Microcyn-based products. The stabilizers include magnesium, and Ruthigen believes the FDA should review it as a biopharmaceutical agent and not a medical device.
The agent is being tested for use in invasive procedures with application directly to internal tissues and organs. The broad-spectrum anti-infective is intended to prevent and treat infection for a number of surgical and trauma procedures. Preclinical testing showed promise in the agent’s ability to stop gram-positive and gram-negative bacteria, including antibiotic resistant bacteria. The trial currently underway is a skin irritation trial. The next step for RUT58-60 is a Phase I/II clinical trial of 150 people for 28 days. The multi-center study will evaluate efficacy, safety, and tolerability.
Surgical Infection Market
Ruthigen states that treatments for preventing abdominal surgery represent a $700 million market. It believes that with RUT58-60, it can optimize patient care, minimize hospital infections, and add to the effort in reducing the threat of antibiotic resistance. The company also seeks to reduce costs, as $10 billion is spent treating hospital acquired infections (HAIs). The company is developing formulations of RUT58-60 for cardiovascular and orthopedic procedures, among others, which may help this young company become a player in the large HAI market.