Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

May 2 2014

Ruthigen, Inc., (NASDAQ: RTGN), a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for its lead drug candidate RUT58-60.  The Company plans to initiate its combined Phase 1/2 clinical trial for RUT58-60, entitled: "A Phase 1/2 Double Blind, Randomized Controlled Study to Evaluate the Safety and Efficacy of RUT58-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics," as early as July 2014.

The principal investigator of the trial will be Dr. Janice Rafferty, M.D. Dr. Rafferty is a colorectal surgeon and endowed Professor of Surgery at the University of Cincinnati's College of Medicine.  Dr. Rafferty has over 18 years of experience in the diagnosis and surgical treatment of colorectal cancer, Crohn's disease, incontinence, ulcerative colitis and other digestive diseases.  She is Chief of the Division of Colon and Rectal Surgery within the University of Cincinnati Department of Surgery, as well as at The Christ Hospital in Cincinnati.  Dr. Rafferty has authored many peer-reviewed articles, and is the recipient of numerous honors for her contributions to colorectal surgery.  Up to 20 clinical sites may be used during this trial.

Ruthigen has incorporated feedback from the FDA, received in connection with the Company's previously conducted pre-IND meeting, into the development program.  The proposed Phase 1/2 trial design contemplates an initial enrollment of approximately 20 patients as part of a brief Phase 1 component of the study to establish the safety and tolerability of RUT58-60 in humans.  The trial will remain blinded with the exception of the safety portion for the initial 20 patients.  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.

Hoji Alimi, Chairman, CEO and CSO of Ruthigen, said: "We expect to complete our combined Phase 1/2 trial by early 2015 and enter into our first pivotal trial, pending FDA review, shortly thereafter.  The combined Phase 1/2 trial is designed as an exploratory trial to evaluate the potential safety and efficacy of RUT58-60 as a prophylactic drug for use in abdominal surgery.  We will also evaluate the potential of our lead drug candidate against the following parameters: 1) infection rates, 2) patient discharge times, and 3) number of patients returning to the hospital due to post-surgical infection.  These three parameters will be evaluated on day 0, at hospital discharge or day 7, day 14 and day 28 post surgery.  Based on the data we collect, we expect to gain meaningful insights to inform the design of the clinical endpoints for our pivotal trials."

SOURCE Ruthigen, Inc.