SANTA ROSA – Ruthigen Inc. (Nasdaq: RTGN) on Thursday announced regulatory approval to advance testing of a new antibiotic for surgery and wound care.
The decision by the Food and Drug Administration cleared the RUT58-60 compound for use in Ruthigen’s first trial, expected to encompass 30 patients and July of 2014.
The 21-day trial will evaluate potential skin irritation from the compound, with results that will influence subsequent Phase 1 and Phase 2 trials evaluating the safety of the product within a patient’s abdominal cavity.
“RUT58-60 has a novel mechanism of action to prevent emergency bacterial resistance and improves patient safety by neither targeting specific bacterial cell membrane receptors nor expositin patients’ vital organs to unnecessary systemic drugs,” said Hoji Alimi, chairman, CEO and chief science officer of Ruthigen, in an announcement.
Ruthigen spun off from Petaluma’s Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) through a $19.2 million public offering in March 2014. The company is hoping to announce clinical trial results in early 2015.
The RUT58-60 compound is meant to be applied directly to a surgical area or wound, limiting the risk of infection in a manner that emulates mechanisms of the body’s immune system. While seeing market opportunity for abdominal applications, the RUT58-60 compound may also have applications for preventing infection elsewhere in the body.
Shares in Ruthigen were trading at $6.73 in midday trading on Thursday.