Pathogenics Inc. is a privately held pharmaceutical company that is currently developing the clinical-stage, novel anti-infective/anti-inflammatory medicine N-Chlorotaurine (NCT) for the treatment of mild to severe COVID-19 cases and other infections.
The Company focuses on developing novel therapeutic drugs that target unmet medical needs. It identifies opportunities through collaboration with scientific research institutions and industry contacts with the goal of developing promising early stage drug candidates into human clinical trials and through FDA regulatory approval.
The Company in-licenses its experimental drugs, demonstrates they work in small-scale human clinical trials, and then partners with large pharmaceutical companies who are seeking new drugs to fill their product pipelines. These partners then complete larger-scale clinical trials, obtain US FDA new drug approval, and market the drugs worldwide. This business strategy is designed to minimize fixed costs, add significant value to our experimental drugs, and accelerate the time to corporate profitability.
In response to the current COVID-19 pandemic, the Pathogenics Inc. is continuing to collaborate with the original researchers/inventors of NCT to develop it as a medicine for the treatment of mild to severe COVID-19 cases and other infections. Even in the presence of organic material simulating body fluids (human mucus), NCT kills the COVID-19 virus (SARS-CoV-2) within 10 minutes, absent cytotoxicity of inactivated NCT to the inoculated cell culture.
An important milestone of NCT drug development is the completion of a controlled, randomized, double-blind Phase I human clinical trial, which demonstrated in human subjects the safety, high tolerability and absence of considerable adverse effects of 1% NCT inhalation.
History of Pathogenics and NCT
The original researchers/inventors of N-chlorotaurine (NCT), Dr. Waldemar Gottardi, PhD (retired) and Dr. Markus Nagl, MD at the University of Innsbruck, Austria, began their research and development collaboration with Pathogenics Inc. when its predecessor corporation licensed from them the worldwide rights to NCT on October 18, 2001. By then, the compound had already completed safety and tolerability studies in a limited number of subjects, and had begun a series of phase II human clinical studies for the treatment of several indications, including viral and bacterial conjunctivitis, and acute and chronic sinusitis.
Because of NCT’s demonstrated safety profile and broad spectrum activity established in preclinical and clinical studies, the Company continued the development of NCT as a promising agent for the treatment of several infections. It funded (together with various other sub-licensees and assignees) numerous preclinical, formulation, toxicology and clinical studies necessary to support the filing of an FDA IND application on NCT. The Company continued to evaluate the safety and efficacy of NCT throughout the completion of ongoing clinical trials.
All the clinical trials conducted to date on NCT were conducted according to Good Clinical Practice (“GCP”) guidelines. GCP guidelines are internationally accepted (including the USA) ethical and scientific quality standards for designing, conducting, recording, monitoring, auditing, analyzing and reporting clinical trials that involve the participation of human subjects. Compliance with these standards provides public assurance that the rights, safety, and well-being of trial subjects are protected, and that the clinical trial data are credible.