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Cetylpyridinium chloride - ARMS Pharmaceutical

Drug Profile

Cetylpyridinium chloride - ARMS Pharmaceutical

Alternative Names: ARMS-I; CPC

Latest Information Update: 07 Apr 2020

At a glance

  • Originator ARMS Pharmaceutical
  • Developer ARMS Pharmaceutical; University Hospitals Cleveland Medical Center; University of Toledo
  • Class Antiseptics; Disinfectants; Pyridinium compounds; Small molecules
  • Mechanism of Action Cell membrane modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Respiratory tract infections
  • Preclinical COVID 2019 infections; Influenza virus infections

Most Recent Events

  • 02 Apr 2020 ARMS Pharmaceutical, University Hospitals Cleveland Medical Center and Case Western Reserve University plan the ARMS-I COVID Study in COVID-2019 infections (Prevention, Treatment) in USA (PO) in April 2020
  • 07 Mar 2017 Chemical structure information added
  • 06 Feb 2017 ARMS Pharmaceutical has patents pending for ARMS-I platform in USA, Europe, Japan, China, Brazil, India, Korea, Canada, Mexico, Israel (ARMS Pharmaceutical, February 2017)

Development Overview

Introduction

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 [1] .

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 [2] .

Financing information

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 [1] .

Patent Information

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).

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Spray
  • Class Antiseptics, Disinfectants, Pyridinium compounds, Small molecules
  • Target Cell membrane
  • Mechanism of Action Cell membrane modulators
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

    J5B (Antivirals, excluding anti-HIV products)

  • Chemical name 1-Hexadecylpyridinium chloride
  • Molecular formula C21 H38 N Cl
  • Chemical Structure
  • CAS Registry Number 123-03-5

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical USA PO / Spray ARMS Pharmaceutical, University Hospitals Cleveland Medical Center 02 Apr 2020
Influenza virus infections - Prevention Preclinical USA PO / Spray ARMS Pharmaceutical, University Hospitals Cleveland Medical Center 02 Apr 2020
Respiratory tract infections Upper Respiratory Tract - Phase II USA PO / Spray ARMS Pharmaceutical, University of Toledo, University Hospitals Cleveland Medical Center 01 Jan 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
ARMS Pharmaceutical Originator USA
ARMS Pharmaceutical Owner USA
Cleveland Clinic Foundation Funder
University of Toledo Collaborator USA
University Hospitals Cleveland Medical Center Collaborator USA

Future Events

Expected Date Event Type Description Updated
21 Apr 2020 Trial Update ARMS Pharmaceutical, University Hospitals Cleveland Medical Center and Case Western Reserve University plan the ARMS-I COVID Study in COVID-2019 infections (Prevention, Treatment) in USA (PO) in April 2020 (700320447) [1] 07 Apr 2020

Development History

Event Date Update Type Comment
02 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (PO) before April 2020 [1] Updated 07 Apr 2020
02 Apr 2020 Phase Change - Preclinical Preclinical trials in Influenza virus infections (Prevention) in USA (PO) before April 2020 [1] Updated 07 Apr 2020
02 Apr 2020 Regulatory Status ARMS Pharmaceutical files an IND application with the US FDA for clinical development in Influenza virus infections (Prevention) (PO) before April 2020 [1] Updated 07 Apr 2020
02 Apr 2020 Trial Update ARMS Pharmaceutical, University Hospitals Cleveland Medical Center and Case Western Reserve University plan the ARMS-I COVID Study in COVID-2019 infections (Prevention, Treatment) in USA (PO) in April 2020 [1] Updated 07 Apr 2020
07 Mar 2017 Other Chemical structure information added Updated 07 Mar 2017
06 Feb 2017 Patent Information ARMS Pharmaceutical has patents pending for ARMS-I platform in USA, Europe, Japan, China, Brazil, India, Korea, Canada, Mexico, Israel (ARMS Pharmaceutical, February 2017) Updated 06 Feb 2017
01 Feb 2017 Active Status Review NCT03026205 - new profile Updated 06 Feb 2017
31 Jan 2017 Trial Update ARMS Pharmaceutical withdraws a phase II trial in Respiratory tract infections in USA, prior to enrolment (PO) (NCT03026205) Updated 30 Apr 2019
01 Jan 2017 Phase Change - II Phase-II clinical trials in Respiratory tract infections in USA (PO) (NCT03026205) Updated 09 Feb 2017
31 Mar 2015 Patent Information ARMS Pharmaceuticals has patent protection for ARMS-I platform in US (ARMS Pharmaceutical, February 2017) Updated 06 Feb 2017
01 Sep 2013 Patent Information ARMS Pharmaceuticals has patent protection for ARMS-I platform in US (ARMS Pharmaceutical, February 2017) Updated 06 Feb 2017

References

  1. UH to launch clinical trial in the fight to protect clinicians against COVID-19.

    Media Release
  2. Evaluation of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Orally Administered ARMS-I Administered in Healthy Adults, Aged 18-45 Years

    ctiprofile
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