ABOUT THE COMPANY
We are a biopharmaceutical company focused on the discovery, development, and commercialization of pharmaceutical-grade hypochlorous acid-based (HOCl) therapeutics designed to prevent and treat infection in invasive applications.

✴ 6014 Snell Avenue, San Jose, CA 95123, United States

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Our lead drug candidate, RUT58-60, is a broad spectrum anti-infective that we are developing for the prevention and treatment of infection in surgical and trauma procedures. We are focusing RUT58-60 for use initially in abdominal surgery due to the large addressable market, high rate of post-surgical infection associated with abdominal surgery, the high-impact opportunity that abdominal surgery offers us in the clinical trial setting to expose multiple internal organs to RUT58-60 at one time, and feedback from surgeons identifying post-surgical infection in abdominal surgery (relative to other surgeries) as a significant unmet medical need.

History

Ruthigen, Inc. (“Ruthigen”) was incorporated under the laws of the State of Nevada on January 18, 2013 as a wholly-owned subsidiary of Oculus Innovative Sciences, Inc. (“Oculus”). Ruthigen intends to spin-off from Oculus and independently fund research and development and commercialization of RUT58-60 and future drug development candidates. Ruthigen is developing RUT58-60, a hypochlorous acid-based solution, with two to four times the concentration of Microcyn® based products manufactured by Oculus while meeting the stringent drug requirements mandated by FDA including but not limited to sterility, stability, safety and efficacy. RUT58-60 contains small molecule stabilizers including magnesium and no hypochlorite and is intended for use during invasive procedures with direct exposure to internal tissue and organs. RUT58-60 uses design elements that management believes will allow the product to be evaluated and reviewed as a biopharmaceutical agent, as opposed to a medical device.

We have entered into a series of agreements with Oculus that will govern our technology license, exclusive rights to develop and commercialize our drug candidate and future hypochlorous-acid based drug candidates in the United States, Canada, the European Union and Japan (the “Territory”), and the separation of the companies.

RUT58-60: A Revolutionary Approach to Preventing Surgical Infections

RUT58-60 is our innovative hypochlorous acid-based drug candidate designed to prevent and treat infections in surgical and trauma procedures. Unlike traditional antibiotics, it offers multiple advantages:

Broad-Spectrum, Fast-Acting Protection

RUT58-60 effectively kills bacteria, viruses, spores, and fungi through a process called denaturation, where the structure of surface proteins on pathogens is irreversibly damaged. Non-clinical studies show rapid action, with potent 30-second kill times against various antibiotic-resistant bacteria, including MRSA and VRE.

Prevents Superbug Development

RUT58-60 targets multiple sites on bacteria, reducing the risk of resistance and superbug emergence. By causing irreversible protein damage, it ensures bacteria cannot adapt or survive, making it a powerful prophylactic option for surgical settings.

Pro-Healing Potential

Initial clinical trials suggest that RUT58-60 may accelerate healing, potentially leading to faster recovery and discharge for patients. Hypochlorous acid's natural healing properties have been shown to improve tissue repair, reducing complications and hospital stays.

Mimics the Body’s Natural Defense

RUT58-60 mimics the body's own immune response, using hypochlorous acid to attack microbes without fostering resistance. Our formulation enhances this natural mechanism, providing a powerful yet safe alternative to antibiotics.

Easy Integration for Surgeons

Using RUT58-60 requires no change in surgical protocols. It replaces standard saline irrigation solutions without additional training, making it an effortless transition for surgical teams.

Prepackaged, Sterile, Ready-to-Use

RUT58-60 will come in convenient, pre-sterilized packaging, eliminating the need for mixing or preparation. This reduces the risk of contamination and human error, streamlining infection prevention during surgery.

Stable and Biocompatible

Our formulation ensures enhanced biocompatibility, making RUT58-60 safe for internal use. Unlike traditional hypochlorous acid products, it remains stable without special storage, with a shelf life of up to two years.

Cost-Saving Benefits

By preventing infections, RUT58-60 has the potential to reduce hospital readmissions, lower patient care costs, and minimize the need for systemic antibiotics. This could lead to significant savings for healthcare facilities, improving outcomes and cutting costs.

In summary, RUT58-60 represents a breakthrough in surgical infection prevention, offering a safe, stable, and easy-to-use solution that could transform patient care and hospital protocols.

Our Science

We are developing our lead drug candidate, RUT58-60, for the prevention and treatment of infection in surgical and other invasive applications. The initial indication that we are pursuing is for use in abdominal surgery. The active pharmaceutical ingredient in RUT58-60 is hypochlorous acid. It is manufactured without any sodium hypochlorite, and it incorporates additional small molecules, such as magnesium, the result of which increases the stability and biocompatibility of the compound so that it may be used in direct contact with internal organs. We believe that we are the first company to have produced a shelf stable and tissue biocompatible form of hypochlorous acid that will satisfy FDA’s safety and efficacy requirements as a drug for invasive use.

Chemistry of Hypochlorous Acid

HOCl is extremely unstable as it is produced in the body or under laboratory conditions. Drug formulations in general must maintain less than 10% degradation during their shelf life. The short shelf life of HOCl is attributable to its weak chlorine bond that makes it extremely difficult to be manufactured as a stable drug.

Hypochlorous acid has demonstrated to be potent and fast acting through targeting non-specific biomolecules on bacterial cell membrane. Initial cell surface reactions to hypochlorous acid have been reported to occur in as little as 100 milliseconds. It is widely documented that hypochlorous acid readily reacts with a wide range of biomolecules including DNA strands, RNA strands, fatty acid groups, cholesterol and proteins amongst others. It is a highly reactive compound and upon reaction it is completely rendered neutral. Unlike antibiotics, the potency of HOCl and damage is delivered with no specificity. We believe, this mechanism of action induced by hypochlorous acid significantly reduces the potential for emergence of new superbugs.

Hypochlorous acid damages the integrity of the bacterial cell membrane through increasing its permeability. The rapid drop in bacterial viability followed by immediate cell membrane integrity damage at concentrations of approximately 0.05mM to 0.1mM of hypochlorous acid. By contrast, RUT58-60 contains 2.0mM of hypochlorous acid, which represents a 40-fold increase in the minimal concentration of HOCl needed to initiate bacterial cell membrane damage.

Hypochlorite or Hypochlorous Acid

The science of hypochlorous acid is not well understood in the industry. For example, it has been demonstrated that hypochlorous acid reacts with unsaturated bonds in lipids which comprise the bacterial cell membrane, whereas bleach (OCl−) does not participate in this reaction. While topical disinfectants such as bleach may induce necrosis in certain open wounds, we have demonstrated that exposure to hypochlorous acid both in vivo and in vitro induces no harm. In contrast to hypochlorite, hypochlorous acid is highly tolerated by mammalian cells. Mammalian cells contain cellular amino acids and pumps that assist in neutralizing HOCl and keeping mammalian cells safe. Mammalian cells contain amino acids such as Taurine that help protect the cells from the oxidation process caused by HOCl.

Clinical Benefits of Hypochlorous Acid

Hypochlorous acid has also been studied for purposes of evaluating, and has been shown to demonstrate, pro-healing capabilities. Improvement with statistical significance in clinical success has been demonstrated, as determined by the complete resolution of signs and symptoms of disease, in diabetic foot ulcer patients. According to Landsman et al., JAPMA, 2011, the hypochlorous acid group with levofloxacin outperformed a control group of patients that used saline with levofloxacin, an antibiotic commonly used with these patients. The hypochlorous acid group with levofloxacin showed a 93% success rate at 28 days vs. a 56% success rate in the control group using saline plus levofloxacin.

Hypochlorous Acid Activity is Irreversible

HOCl targets and disrupts the energy cycle within bacteria (adenosine triphosphate – ATP). ATP is the central function for production of energy for bacteria. Therefore, hypochlorous acid first, induces irreversible damage to bacterial cell membrane proteins thus interrupting the proteins’ functionality, then it targets the bacterial cell membrane and finally shuts down the center for production of energy for bacteria. As a direct result of protein damage by hypochlorous acid, cellular metabolism is disrupted causing a principally decreased production of Adenosine-5’’-triphosphate, energy production (ATP), a universal, biological energy storage and transfer molecule. Studies show protein instability induced by hypochlorous acid is non-reversible.

Source for Production of Hypochlorous Acid

Other sources for production of hypochlorous acid includes our white blood cells. Neutrophils, a specific type of white blood cells, are responsible for production of hypochlorous acid to fight infection. Our body’s immune system has evolved to incorporate the use of hypochlorous acid to fight pathogens. The production of hypochlorous acid by immune cells requires the involvement of additional biomolecules and transient chemicals. Myeloperoxidase has been reported as the key enzyme to convert hydrogen peroxide into hypochlorous acid in our body. Therefore, higher concentrations of myeloperoxidase are required by our body to produce the potent concentrations of hypochlorous acid found in RUT58-60. However, the higher presence of myeloperoxidase and its oxidative ability is associated with toxicity and damage found in patients suffering from late stage kidney disease.

Clinical Programs

We have focused on identifying additional surgical procedures for our proprietary formulations, beyond the initial indication for use in the prevention of infection associated with abdominal surgery. We evaluate and prioritize additional surgical procedures based on the likelihood of the patient contracting a post-surgical infection in a certain type of surgery, the length of the post-surgical hospital stay and the potential to shorten the stay with RUT58-60, the likelihood of patient readmission following discharge due to having contracted a post-surgical infection and general feedback from surgeons regarding the anticipated clinical impact of a product such as RUT58-60 being used following other types of surgical procedures. Based on our initial research and development, following abdominal surgery, we are evaluating the various formulations for prevention or treatment of infection following cardiovascular procedures and orthopedic amongst others.

6017 Snell Avenue, San Jose, CA 95123, United States

ABOUT THE COMPANYWe are a biopharmaceutical company focused on the discovery, development, and commercialization of pharmaceutical-grade hypochlorous acid-based (HOCl) therapeutics designed to prevent and treat infection in invasive applications.