ARMS Pharmaceutical is developing an oral spray formulation of cetylpyridinium chloride, designated ARMS I, for the treatment and prevention of infectious disease, including upper respiratory tract infections, and for prevention of influenza virus infections and COVID-2019 infections. In vitro and in vivo studies has demonstrated that ARMS I prevents and treats upper respiratory tract infections by catching and killing a broad spectrum of pathogenic micro-organisms as they enter the upper respiratory tract. ARMS I controls infections without side effects and microbial resistance issues. Clinical development in respiratory tract infections and preclinical development for prevention of influenza virus infections and COVID-2019 infections is underway in the US.
Key Development Milestones
In April 2020, ARMS Pharmaceutical reported that it had submitted an IND application to the US FDA, to seek authorisation for the conduct of a clinical trial to evaluate cetylpyridinium chloride, for potential influenza prophylaxis. Preclinical studies have highlighted the ability of the drug in killing enveloped viruses, including influenza. This antiviral ability, the company believes could also be potentially extrapolated for prevention of COVID-2019 infections. However, clinical evidence is necessary. Results from a study have indicated that one of the active ingredients in cetylpyridinium chloride, had potent antiviral activity against coronavirus MERS-CoV  .
In January 2017, ARMS Pharmaceutical in collaboration with University of Toledo Health Science Campus withdrew the phase II ARMS-1 trial prior to enrolment (16-191; NCT03026205). The trial was designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of orally administered cetylpyridinium chloride, in healthy volunteers in the US  .
In April 2020, ARMS Pharmaceuticals reported that Cleveland Foundation authorised $US1 million in emergency funding to support a significant portion of a planned clinical trial for COVID-2019 infections, from previously restricted health-related research grant dollars at the foundation  .
In March 2015, ARMS Pharmaceutical was granted US compositional patent number 8 992 893 for ARMS-I platform. The company is also pursuing protection on method and composition patents in USA, Europe, Japan, China, Brazil, India, Korea, Canada, Mexico, Israel (ARMS Pharmaceutical, February 2017).
In September 2013, ARMS Pharmaceutical was granted US patent number 8 535 646 B2 for ARMS-I platform. The patent covers method for blocking, neutralizing, or killing microorganisms that cause infectious disease (ARMS Pharmaceutical, February 2017).