Ruthigen, Inc. (RTGN) received encouraging news regarding the development of its lead pipeline candidate RUT58-60 when the Data Monitoring Committee (DMC) recommended the initiation of a phase I/II study.
Ruthigen is evaluating RUT58-60 for use in combination with prophylactic systemic antibiotics for the prevention and treatment of infections in abdominal surgical and trauma procedures.
The DMC’s recommendation is based on data from a 21-day skin irritation study completed this month.
The controlled, randomized, double-blind and multi-centered phase I/II study (n=150) will evaluate the safety, tolerability and efficacy of RUT58-60. Ruthigen intends to commence enrolling patients in September.
The company intends to enroll 20 patients initially. Once the safety results on these patients are reviewed and the DMC issues a recommendation to proceed, Ruthigen will enroll an additional 130 patients. The company expects to complete the initial part of the trial by late 2014. Ruthigen expects to complete the phase I/II study by late first quarter 2015. If all goes well, the company would be in a position to commence pivotal studies in mid-2015 or late 2015.
Ruthigen intends to submit a new drug application in late 2017 on successful completion of pivotal studies.
In the long run, Ruthigen plans to develop RUT58-60 for use in orthopedic, cardiovascular, spinal and other types of invasive surgeries.
Ruthigen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include Hyperion Therapeutics, Inc. (HPTX), Endo International plc (ENDP) and United Therapeutics Corporation (UTHR). All three carry a Zacks Rank #1 (Strong Buy).
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