N-Chlorotaurine (NCT) is ideally suited as a broad-spectrum anti-infective medicine for the treatment of local infections in humans, including:
To ultimately beat COVID-19, we’ll need an effective antiviral medication or immunity through a vaccine. It is highly unlikely that a vaccine will ever eliminate the spread of COVID-19, because vaccines seldom confer truly “sterilizing immunity” (the key factor in eliminating the spread of smallpox – the only human disease eradicated by a vaccine). It is far more likely that COVID-19 will continue to circulate for many years, and become endemic like the seasonal flu.
The rapid emergence of new SARS-CoV-2 strains will continually render vaccines less effective, and lead to a revolving cycle of vaccine development and administration to cope with emerging strains, like the annual flu shot. The only alternative this vaccine mutation merry-go-round is an effective antiviral medication. However, this goal continues to be as elusive as a vaccine which confers “sterilizing immunity”.
Current Treatments: Safe, well tolerated, affordable, and effective medications are urgently needed against SARS-CoV-2 and its emerging vaccine resistant mutant strains, and they would be beneficial for treatment of viral pneumonia caused by other viruses such as influenza and RSV. Antiviral drugs are often specific to distinct viruses, but acute respiratory virus infections present indistinguishable symptoms, therefore the ideal antiviral drug should have broad-spectrum antimicrobial activity so that it could be effectively administered regardless of the pathogen.
The antiviral remdesivir is less than optimal against COVID-19, since it is relatively difficult to intravenously administer, does not decrease mortality, has serious side effects, and is costly (thousands of dollars per dose). Antibody therapies (that mimic vaccines’ acquired immune response approach) appear to have limited utility, and have not been widely adopted. Although dexamethasone decreases mortality in seriously-ill patients on ventilators, it also has undesirable side-effects so it is only used as a drug of last resort.
NCT Treatment: Pathogenics, Inc. is currently focused on the clinical development of NCT, a broad-spectrum antimicrobial compound, as a novel anti-infective/anti-inflammatory medicine for the prophylaxis and treatment of COVID-19 in mild-to-severe cases.
NCT clearly demonstrates antiviral/virucidal activity, in vitro, against SARS-CoV-2 (COVID-19 virus) at concentrations that are well tolerated in humans, and against other common respiratory viruses including respiratory syncytial virus (RSV), and the influenza A virus. In the presence of organic human body fluids (e.g., mucus), NCT was able to rapidly kill the viruses within 1 – 10 minutes, absent cytotoxicity of inactivated NCT to the inoculated cell culture. Research Square. 2020 (preprint).
NCT is just as effective at killing bacteria and fungi, including multi-resistant ones, which may cause deadly secondary and super infections. Unlike antibiotics and vaccines which are susceptible to resistant strains, NCT is not susceptible to drug resistance because of its non-specific oxidizing mechanism of action.
NCT has also previously demonstrated anti-inflammatory activity, which has the potential to prevent airway damage in severely ill COVID-19 patients by downregulating the aggressive ‘cytokine storm’ inflammatory response. NCT is known to be involved in the termination of acute inflammation, e.g. by directly decreasing the production of tissue-damaging mediators (pro-inflammatory cytokines TNF-α, IL-1β and IL-6) created by white blood cells when they encounter a pathogen and initiate inflammation.
Drug-resistant infections – those that are not killed or inhibited by anti-infective drugs – are an increasingly important public health concern. More than two-thirds of the bacterial infections acquired in U.S. hospitals and about half of the common bacterial infections in outpatients do not respond to at least one of the antibiotics that used to work, and many physicians are concerned that several bacterial infections soon may be untreatable.
Current Treatments: Topical and body cavity infections are a major therapeutic area for application of anti-infectives, and require local application of the drug to kill the infection. Treatment of sinusitis and ear infections are the first and second most common reasons for antibiotic prescriptions, and the culprit, Streptococcus pneumoniae, is more likely to be resistant than any other common bacteria.
NCT Treatment: NCT causes a stunning increase of microbicidal activity when it is applied in the presence of inflammatory secretions (e.g. human nasal mucus). As a result, even omniresistant Pseudomonas aeruginosa (bacterium resistant against all available antibiotics) is killed in human urine by NCT within minutes.
NCT has an unspecific (non-selective) oxidizing mechanism of action that precludes the development of resistant microorganisms – a characteristic similar to those of antiseptics and disinfectants. This attribute differentiates it significantly from antibiotics, antivirals and antifungals, all of which pathogens eventually develop resistant strains.
Despite its broad-spectrum activity, the cytotoxicity of NCT against human cells is extremely low. Its breakdown products, the amino acid taurine and chloride, are also found in the human body (endogenous) and therefore represent virtually no toxic potential and do not induce allergic reactions. This is a unique and outstanding feature in disinfection practice, and differentiates it significantly from antiseptics and disinfectants.
Sinusitis is an inflammation of the sinuses caused by an allergy or a viral, bacterial, or fungal infection. In the majority of cases, inflammation of the paranasal sinuses (sinusitis) is accompanied by inflammation of the nasal passages (rhinitis). Acute sinusitis may be caused by a variety of bacteria and often develops after a viral infection of the upper airways, such as the common cold. The condition may be due to viral, bacterial or fungal growth, or to a self-perpetuating inflammatory process.
Incidence: Sinusitis is one of the most common infections in the United States. Millions of cases occur each year, affecting all age groups and all segments of the population. Approximately 25% of the population will have a sinusitis episode at some time. It is one of the main reasons for which an antibiotic is prescribed and for lost productivity in the work force (e.g., the Medical Outcomes Study SF-36).
Current Treatments: Despite the common nature of rhinosinusitis, its management is controversial. Treatment of acute sinusitis is aimed at improving sinus drainage and curing the infection. Therapies are usually directed to alleviating or reducing symptoms, eradicating the underlying cause, or both. Because bacterial infection of the sinuses is potentially serious, antimicrobials are prescribed to prevent complications. When antibiotics aren’t effective, surgery may be performed to improve sinus drainage and remove infected material.
NCT Treatment: Phase 2a Human Safety & Tolerability Trial. An open label study with no control group was conducted in 12 patients suffering from rhinosinusitis including polyposis nasi. 10-20ml of NCT aqueous solution via a special nose catheter (YAMIK) was applied to the nasal and paranasal cavities 3 lavages a week for 4 weeks. Auris Nasus Larynx. 2005; 32: 359-364.
Conjunctivitis (Pink Eye)
Conjunctivitis is inflammation of the thin membrane (conjunctiva) covering the white of the eye (sclera) and the inner surface of the eyelid. When the conjunctiva becomes irritated or inflamed, the blood vessels which supply it enlarge and become much more prominent (bloodshot), the eye turns red or pink (pink eye), and a discharge often appears in the eye. Conjunctivitis is usually caused by viruses, bacteria, or an allergy.
Incidence: Conjunctivitis is one of the most common nontraumatic eye complaints resulting in presentation to the emergency department. Conjunctivitis is considered extremely common in the US. 3% of all emergency department visits are ocular related, and conjunctivitis is responsible for approximately 30% of all eye complaints.
Current Treatments: Treatment for conjunctivitis depends on the cause. If the cause is a bacterial infection, antibiotic eye drops or ointment may be prescribed. Bacterial conjunctivitis usually resolves itself in two weeks without treatment, and may clear up in 48 – 72 hours with treatment. Antibiotics don’t help allergic or viral conjunctivitis, and there is no approved treatment for viral conjunctivitis.
NCT Treatment: Phase 2a Human Safety and Tolerability Trial. Open pilot study in 10 patients with infectious conjunctivitis (7 bacterial, 3 viral). Application of 1 % NCT 5 times a day. NCT proved to be excellently tolerated and showed no adverse effects. All seven subjects with bacterial conjunctivitis were cured within 3 – 5 days. Two subjects with epidemic keratoconjunctivitis were treated for 7-10 days and 1 subject with herpes simplex blepharitis for 3 days with no rapid improvement but probable mitigation of inflammation. Ophthalmologica. 2000; 214(2): 111-114.
Phase 2bTrial. Efficacy and tolerability in 60 patients suffering from viral conjunctivitis (preferentially adenoviral = epidemic keratoconjunctivitis). Double blind, randomised. Control group: gentamycin eye drops. J Ocular Pharmacol Ther. 2005; 21: 157–165.
Otitis Externa (Swimmer’s Ear)
External otitis (otitis externa) is an infection of the ear canal, often called swimmer’s ear, and is most common during the summer swimming season. Symptoms of generalized external otitis are itching, pain, and a malodorous discharge. A variety of bacteria (90%), or rarely, fungi (10%), can cause generalized external otitis.
Current Treatments: To treat generalized external otitis, a doctor first removes the infected debris from the canal with suction or dry cotton wipes. After the ear canal is cleared, hearing frequently returns to normal. For bacterial external otitis, a person is usually given antibiotic eardrops to instill in the ear several times a day for up to a week.
NCT Treatment: Phase 2b Human Efficacy Trial. Open label, controlled and randomised clinical study in 50 patients with otitis externa. Application of 1% NCT via a strip (or by direct rinsing in special cases with abscesses) into the external ear canal verses the topical antibiotic Otosporin for 5 days. This study was completed in January 2003. NCT proved to be excellently tolerated and highly active. NCT proved significantly (P<.001) more rapid healing than Otosporin. In patients with abscesses including one with a fungal abscess NCT was clearly superior to common treatment. Laryngoscope. 2004; 114: 850-854.