Cetylpyridinium chloride - ARMS Pharmaceutical
Alternative Names: ARMS-I; CPCLatest Information Update: 07 Jan 2022
At a glance
- Originator ARMS Pharmaceutical
- Developer ARMS Pharmaceutical; University Hospitals Cleveland Medical Center; University of Toledo
- Class Antiseptics; Antivirals; Disinfectants; Pyridinium compounds; Small molecules
- Mechanism of Action Cell membrane modulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preclinical COVID 2019 infections; Influenza virus infections
- Discontinued Respiratory tract infections
Most Recent Events
- 27 Oct 2020 Discontinued - Phase-II for Respiratory tract infections in USA (PO)
- 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
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. Preclinical development for prevention of influenza virus infections and COVID-2019 infections is underway in the US.
Clinical development was underway in the US for the treatment of upper respiratory tract infections. However no recent reports of development have been reported for the same.
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, Antivirals, 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
- SMILES C1=CC=CC=[N+]1CCCCCCCCCCCCCCCC.[Cl-]
-
Chemical Structure
- CAS Registry Number 123-03-5
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Cetylpyridinium chloride - ARMS Pharmaceutical | 24,25-Dihydroxyvitamin D | Outcome Measure |
| ACPP | Official Title | |
| Adiponectin (ADIPOQ) | Brief Title, Official Title | |
| Alkaline phosphatase (ALPL) | Eligibility Criteria | |
| alpha-Tocopherol acetate | Arm Group Description | |
| Amyloid beta precursor protein (APP) | Outcome Measure | |
| BNP | Outcome Measure | |
| C-reactive protein (CRP) | Brief Summary, Outcome Measure | |
| Cardiac Troponin I | Eligibility Criteria, Outcome Measure | |
| cardiomyopathy, dilated 1B (autosomal dominant) | Detailed Description | |
| CD56 | Outcome Measure | |
| CDGSH iron sulfur domain 3 | Arm Group Description | |
| Citric acid | Arm Group Description | |
| Creatine | Outcome Measure | |
| Creatinine | Eligibility Criteria | |
| crooked neck pre-mRNA splicing factor 1 | Brief Title | |
| CXCR4 | Official Title | |
| Ethylene oxide/propylene oxide copolymer | Arm Group Description | |
| fatty acid binding protein 3 | Outcome Measure | |
| Fc fragment of IgG receptor Ib | Outcome Measure | |
| Fibrinogen | Detailed Description | |
| FRYL | Brief Title, Official Title | |
| GFAP | Outcome Measure | |
| Granulocyte-macrophage colony-stimulating factor (GM-CSF) | Outcome Measure | |
| Hematopoietic progenitor cell antigen CD34 | Outcome Measure | |
| Human Microbiome | Brief Title, Official Title | |
| Hyaluronan | Arm Group Label, Official Title | |
| Hyaluronic acid | Arm Group Label, Official Title | |
| Hydrocortisone | Outcome Measure | |
| IGF1 | Outcome Measure | |
| Interleukin 1 alpha (IL-1α) | Outcome Measure | |
| Interleukin 1 Beta (IL-1β) | Outcome Measure | |
| Interleukin-10 (IL-10) | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure | |
| LPA | Outcome Measure | |
| malate dehydrogenase 1, NAD (soluble) | Brief Title, Official Title | |
| Methanethiol | Eligibility Criteria | |
| Monocyte chemoattractant protein-1 (MCP-1/CCL2) | Outcome Measure | |
| myelin basic protein | Outcome Measure | |
| myostatin | Outcome Measure | |
| Neuron-specific enolase (NSE) | Brief Summary, Detailed Description, Outcome Measure | |
| NGAL | Arm Group Description, Brief Summary, Brief Title, Detailed Description, Official Title | |
| P-selectin | Outcome Measure | |
| PGE2 | Outcome Measure | |
| proteasome subunit alpha 7 | Detailed Description | |
| PSA | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| Pyruvic acid | Arm Group Description, Detailed Description, Outcome Measure | |
| RAS | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| RNA binding region (RNP1, RRM) containing 3 | Detailed Description | |
| S100 calcium binding protein A1 | Arm Group Description, Detailed Description, Outcome Measure | |
| S100B | Arm Group Description, Detailed Description, Outcome Measure | |
| seryl-tRNA synthetase 2, mitochondrial | Official Title | |
| Sorbitol | Arm Group Description | |
| Testosterone | Eligibility Criteria | |
| Transforming growth factor-beta (TGF-beta) | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Eligibility Criteria, Outcome Measure | |
| Xanthan | Arm Group Description | |
| XPA binding protein 2 | Brief Title |
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 | - | Discontinued (II) | USA | PO / Spray | ARMS Pharmaceutical, University of Toledo, University Hospitals Cleveland Medical Center | 27 Oct 2020 |
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 |
|---|---|---|
| 05 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 07 Jan 2022 |
| 27 Oct 2020 | Phase Change - Discontinued(II) | Discontinued - Phase-II for Respiratory tract infections in USA (PO) Updated 27 Oct 2020 |
| 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
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UH to launch clinical trial in the fight to protect clinicians against COVID-19.
Media Release -
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
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