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.