SANTA ROSA, Calif.
, 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."
Ruthigen is a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications. The Company's lead drug candidate, RUT58-60, is a broad spectrum anti-infective that Ruthigen is developing for the prevention and treatment of infection in surgical and trauma procedures. The Company plans to initiate patient enrollment for its Phase 1/2 clinical trial for RUT58-60 in the United States in July 2014 and pending the successful completion of that trial and its planned pivotal clinical trials, the first of which it anticipates will be its planned Phase 2B trial and the second of which it anticipates will be its planned Phase 3 trial, Ruthigen plans to submit its new drug application to the FDA in late 2017.
RUT58-60 is a new chemical formulation containing hypochlorous acid, HOCl, with no hypochlorite that utilizes other small molecule stabilizers such as magnesium. RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use during invasive surgical procedures, which 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, re-define infection control in surgical procedures and deliver cost savings to hospitals. The Company's clinical program targets an initial $700M potential market in the prevention of infections associated with abdominal surgery. The Company believes the market for prevention of infection in the U.S. surgical market is estimated at $3B.
Except for historical information contained herein, this press release contains "forward-looking statements" (including, but not limited to, statements that contain words such as "will," "believe," "plan," "anticipate," "expect," "estimate") within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: our plans regarding our initial clinical trial, including the timing for initiation and completion, the proposed trial design, the principal investigator, phased enrollment and anticipated data; our plans regarding future clinical trials including potential pivotal trials, our understanding and beliefs regarding the anticipated benefits of our lead drug candidate RUT58-60 to patients and the healthcare system; and our beliefs as to the potential size of the target market for RUT58-60. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading "Risk Factors" contained in the documents filed by Ruthigen with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of the release, and Ruthigen disclaims any obligation to update the information contained in this press release as new information becomes available.
SOURCE Ruthigen, Inc.