Sodium pyruvate - EmphyCorp
Alternative Names: EmphyClear COPD Oral Spray; EmphyClear COPD/Asthma Spray; N115; N115 Non-Steroidal Nasal Spray; Rx N115 non-steroidal nasal spray; Sodium pyruvate inhalation - EmphyCorp; Sodium pyruvate nasal sprayLatest Information Update: 28 Apr 2023
At a glance
- Originator Emphycorp
- Developer Cellular Sciences; Emphycorp
- Class Antiasthmatics; Antifibrotics; Antivirals; Sodium compounds
- Mechanism of Action Interleukin 6 inhibitors; Reactive oxygen species inhibitors
-
Orphan Drug Status
Yes - Interstitial lung diseases; Cystic fibrosis
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase III Interstitial lung diseases
- Phase II/III COVID 2019 infections; Influenza virus infections; Post acute COVID 19 syndrome
- Phase II Asthma; Chronic obstructive pulmonary disease; Cystic fibrosis
- No development reported Lung disorders
Most Recent Events
- 28 Apr 2023 No recent reports of development identified for clinical-Phase-Unknown development in COVID-2019-infections(Prevention) in USA (Inhalation, Spray)
- 12 Aug 2022 Cellular Sciences completes a phase-II/III trial in COVID-2019 infections in USA (Inhalation, In adults) (NCT04824365)
- 12 Aug 2022 Cellular Sciences completes a phase-II/III trial in Influenza virus infections in USA (Inhalation, In adults) (NCT04824365)
Development Overview
Introduction
EmphyCorp is developing an inhaled spray formulation of sodium pyruvate, a small molecule, reactive oxygen species inhibitor, for the treatment of chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, interstitial lung disease, lung disorders, post-acute-COVID-19-syndrome, influenza infections and prevention and treatment of COVID-2019 infections. The candidate is a natural antioxidant and significantly reduces inflammatory agents including IL-6, the cause of the cytokine storm in COVID-2019 patients. Clinical development for chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, interstitial lung disease, post-acute-COVID-19-syndrome, influenza infections and COVID-2019 infections is underway in the US.
Sodium pyruvate inhalation is available for licensing. Also, Emphyorp is seeking partnership to market inhaled sodium pyruvate to prevent COVID-2019 infections [1] [2] .
As at November 2017, no recent reports of development had been identified for clinical-Phase-Unknown development in Lung-disorders in China (Inhalation, spray).
As at April 2023, no recent reports of development had been identified for clinical-Phase-Unknown development in COVID-2019-infections (Prevention) in USA (Inhalation, Spray).
Key Development Milestones
Asthma
According to EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of asthma, and pivotal phase III trials had been planned for 2014. However, as of January 2016, phase III trials had not yet begun.
EmphyCorp initiated a randomised, double-blind, placebo-controlled phase I/II trial in January 2006 to assess the safety and efficacy of inhaled sodium pyruvate in patients with moderate asthma (NCT00262652). The trial was to enrol approximately 55 patients in the US. However, the company reported in June 2011 that trial had been terminated due to a lack of efficacy [3] .
Chronic obstructive pulmonary disease (COPD)
According to EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of COPD, and pivotal phase III trials had been planned for 2014. However, as of January 2016, phase III trials had not yet begun.
EmphyCorp initiated a randomised, double-blind, placebo-controlled phase II trial in September 2004 to investigate the long-term efficacy and safety of inhaled sodium pyruvate in patients with COPD (NCT00262613). The 6-week trial enrolled approximately 60 patients in the US, and was completed in May 2006 [4] .
COVID-2019 infections and influenza infections
In August 2022, Cellular Sciences in collaboration with Missouri State University, Dynamic DNA Labs and Trinity Health Care completed a phase II/III trial that evaluated sodium pyruvate nasal spray for the treatment of COVID-2019 infections and influenza infections (NCT04824365; CSI-COVID-19_007). The randomised, double-blind study was initiated in April 2021, that enrolled 60 patients in the US [5] .
In March 2020, EmphyCorp reported that in 10 human clinical trials, the sodium pyruvate inhalation curbed nasal inflammation and enhanced all lung functions along with an increase in synthesis of nasal nitric oxide. The company believe that nitric oxide has anti-viral effect which has potential to reduce the rate and spread of the COVID-2019 among healthy individuals [1] [6] .
Cystic fibrosis
As per EmphyCorp's pipeline, inhaled sodium pyruvate has completed phase II trials in the US for the treatment of cystic fibrosis in December 2013.
In March 2006, EmphyCorp initiated a single-arm phase I trial to assess the safety and efficacy of inhaled sodium pyruvate in patients with cystic fibrosis (NCT00308243). The trial enrolled approximately 15 patients in the US, and was completed in March 2007 [7] .
EmphyCorp's inhaled sodium pyruvate product was granted orphan drug designation by the US FDA in 2005 for the treatment of cystic fibrosis.
Interstitial lung disease
EmphyCorp's inhaled sodium pyruvate product was granted orphan drug designation by the US FDA in 2005 for the treatment of interstitial lung disease.
As per FDA guidelines, EmphyCorp completed phase III clinical trial for NDA marketing application for the treatment of pulmonary fibrosis in August 2019 [8] .
Post-acute-COVID-19-syndrome
In October 2021, Cellular Sciences with Missouri State University, Dynamic DNA Labs and Trinity Health Care completed a phase II/III trial which evaluated the effects of sodium pyruvate nasal spray on symptoms associated with COVID-19 long haulers (NCT04871815; CSI-COVID-19_009). The open-label trial initiated in April 2021, enrolled 22 participants in the US [9] [10] .
China development
Clinical trials of inhaled sodium pyruvate in unspecified lung indications were initiated in China in 2013.
Patent Information
In April 2020, EmphyCorp reported that inhaled sodium pyruvate is covered by six patents for increasing nasal nitric oxide, and for the treatment of allergic rhinitis, COPD, pulmonary fibrosis, cystic fibrosis, Alzheimer's, concussions, and cancer pre-treatment in the US. The company also has filed two composition drug patents with the US PTO for pulmonary fibrosis, cystic fibrosis and other lung diseases. EmphyCorp also has been granted three patents which claim the ability of N 115 to up regulate the immune system to kill viral infections [1] .
EmphyCorp's inhaled sodium pyruvate product is covered by eight global patents, including two in China and two pending patents in the US.
Drug Properties & Chemical Synopsis
- Route of administration Inhalation
- Formulation Spray
- Class Antiasthmatics, Antifibrotics, Antivirals, Sodium compounds
- Target Interleukin 6; Reactive oxygen species
- Mechanism of Action Interleukin 6 inhibitors; Reactive oxygen species inhibitors
-
WHO ATC code
J05 (Antivirals for Systemic Use)
J05A-X (Other antivirals)
R03B-X (Other drugs for obstructive airways diseases, inhalants)
R07A-X (Other respiratory system products)
-
EPhMRA code
J5B4 (Influenza antivirals)
J5B9 (Antivirals, others)
R3C1 (Non-steroidal respiratory anti-inflammatories, inhalant)
R7X (All Other Respiratory System Products)
- Chemical name Sodium 2-oxopropanoate
- Molecular formula C3 H3 NaO3
- SMILES C(C(=O)C)(=O)[O-].[Na+]
-
Chemical Structure
- CAS Registry Number 113-24-6
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
cystic fibrosis |
Detailed Description |
Tumor necrosis factor alpha (TNF-alpha) Oxidized glutathione Interleukin-8 (IL-8) Interleukin-6 (IL-6) Interleukin 1 Beta (IL-1β) Interleukin 1 alpha (IL-1α) Glutathione Elastase |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Sodium pyruvate - EmphyCorp | Elastase | Detailed Description |
| Glutathione | Detailed Description | |
| Interleukin 1 alpha (IL-1α) | Detailed Description | |
| Interleukin 1 Beta (IL-1β) | Detailed Description | |
| Interleukin-6 (IL-6) | Detailed Description | |
| Interleukin-8 (IL-8) | Detailed Description | |
| Oxidized glutathione | Detailed Description | |
| Pyruvic acid | Arm Group Description, Brief Title, Official Title | |
| Tumor necrosis factor alpha (TNF-alpha) | Detailed Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Asthma | - | - | Phase II | USA | Inhalation / Spray | Emphycorp | 31 Dec 2013 |
| COVID 2019 infections | 18 to 40 years | In adults | Phase II/III | USA | Inhalation / Spray | 03 Apr 2021 | |
| COVID 2019 infections | - | Prevention | No development reported (Clinical) | USA | Inhalation / Spray | Emphycorp | 28 Apr 2023 |
| Chronic obstructive pulmonary disease | - | - | Phase II | USA | Inhalation / Spray | Emphycorp | 30 Sep 2004 |
| Cystic fibrosis | - | - | Phase II | USA | Inhalation / Spray | Emphycorp | 31 Dec 2013 |
| Influenza virus infections | 18 to 40 years | In adults | Phase II/III | USA | Inhalation / Spray | 03 Apr 2021 | |
| Interstitial lung diseases | for pulmonary fibrosis | - | Phase III | USA | Inhalation / Spray | Emphycorp | 12 Aug 2019 |
| Lung disorders | - | - | No development reported (Clinical) | China | Inhalation / Spray | Emphycorp | 04 Nov 2017 |
| Post acute COVID 19 syndrome | symptoms associated with COVID-19 long haulers | In adults | Phase II/III | USA | Inhalation / Spray | Cellular Sciences | 27 Apr 2021 |
Orphan Status
| Indication | Patient Segment | Country | Organisation | Event Date |
|---|---|---|---|---|
| Cystic fibrosis | - | USA | 31 Dec 2005 | |
| Interstitial lung diseases | - | USA | 31 Dec 2005 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Emphycorp | Originator | Unknown |
| Emphycorp | Owner | Unknown |
| Cellular Sciences | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Emphycorp | - | Unspecified | - | 24 Mar 2020 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| EmphyClear COPD Oral Spray | Emphycorp | Chronic obstructive pulmonary disease | USA |
| EmphyClear COPD/Asthma Spray | Emphycorp | Asthma | USA |
Scientific Summary
Therapeutic Trials
The data from phase III clinical trial of inhaled sodium pyruvate for the treatment of interstitial lung diseases demonstrated a statistically and clinically significant increase in forced expiratory volume (FEV-1), oxygen saturation(SaO2), forced vital capacity (FVC) and in FEV-1/FVC ratios (52% to 86%). Significant reduction in coughing, nasal inflammation and congestion was reported in the idiopathic pulmonary fibrosis patients [8] .
In phase II/III trials, inhaled sodium pyruvate reduced nasal congestion and inflammation [1] .
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Apr 2023 | Phase Change - No development reported | No recent reports of development identified for clinical-Phase-Unknown development in COVID-2019-infections(Prevention) in USA (Inhalation, Spray) Updated 28 Apr 2023 |
| 12 Aug 2022 | Trial Update | Cellular Sciences completes a phase-II/III trial in COVID-2019 infections in USA (Inhalation, In adults) (NCT04824365) Updated 04 Oct 2022 |
| 12 Aug 2022 | Trial Update | Cellular Sciences completes a phase-II/III trial in Influenza virus infections in USA (Inhalation, In adults) (NCT04824365) Updated 04 Oct 2022 |
| 05 Oct 2021 | Trial Update | Cellular Sciences and Missouri State University completes a phase II/III trial in Post-acute-COVID-19-syndrome in USA (In adults) (Inhalation) (NCT04871815) [9] Updated 19 Oct 2021 |
| 27 Apr 2021 | Phase Change - II/III | Phase-II/III clinical trials in Post-acute-COVID-19-syndrome (In adults) in USA (Inhalation) (NCT04871815) Updated 17 Aug 2022 |
| 03 Apr 2021 | Phase Change - II/III | Phase-II/III clinical trials in COVID-2019 infections in USA (Inhalation, In adults) (NCT04824365) Updated 07 Apr 2021 |
| 03 Apr 2021 | Phase Change - II/III | Phase-II/III clinical trials in Influenza virus infections in USA (Inhalation, In adults) (NCT04824365) Updated 07 Apr 2021 |
| 07 Apr 2020 | Patent Information | EmphyCorp has patent protection for inhaled sodium pyruvate for the treatment of multiple diseases in USA before April 2020 [1] Updated 14 Apr 2020 |
| 07 Apr 2020 | Patent Information | EmphyCorp has patent protection for inhaled sodium pyruvate for the treatment of Viral infections [1] Updated 14 Apr 2020 |
| 07 Apr 2020 | Patent Information | EmphyCorp has patent pending for inhaled sodium pyruvate for the treatment of Lung diseases in USA before April 2020 [1] Updated 14 Apr 2020 |
| 24 Mar 2020 | Licensing Status | Sodium pyruvate inhalation is available for licensing as of 24 Mar 2020 [2] Updated 30 Mar 2020 |
| 24 Mar 2020 | Regulatory Status | EmphyCorp plans to launch sodium pyruvate inhalation Updated 30 Mar 2020 |
| 17 Mar 2020 | Phase Change - Clinical | Clinical trials in COVID-2019 infections (Prevention) in USA (Inhalation) [6] Updated 23 Mar 2020 |
| 12 Aug 2019 | Phase Change - III | Phase-III clinical trials in Interstitial lung diseases in USA (Inhalation) Updated 23 Jan 2020 |
| 12 Aug 2019 | Scientific Update | Efficacy data from a phase III trial in interstitial lung diseases released by EmphyCorp [8] Updated 23 Jan 2020 |
| 12 Aug 2019 | Trial Update | EmphyCop completes phase III clinical trial for NDA marketing application in interstitial lung diseases [8] Updated 23 Jan 2020 |
| 04 Nov 2017 | Phase Change - No development reported | No recent reports of development identified for clinical-Phase-Unknown development in Lung-disorders in China (Inhalation, spray) Updated 04 Nov 2017 |
| 31 Dec 2013 | Phase Change - Clinical | Clinical trials in Lung disorders in China (Inhalation) Updated 05 Jan 2016 |
| 31 Dec 2013 | Phase Change - II | Phase-II clinical trials in Asthma in USA (Inhalation) Updated 05 Jan 2016 |
| 31 Dec 2013 | Phase Change - II | Phase-II clinical trials in Cystic fibrosis in USA (Inhalation) Updated 05 Jan 2016 |
| 31 Dec 2013 | Phase Change - II | Phase-II clinical trials in Interstitial lung diseases in USA (Inhalation) Updated 05 Jan 2016 |
| 19 Jul 2011 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 24 Jun 2011 | Trial Update | EmphyCorp terminates a phase I/II trial in Asthma in USA (NCT00262652) Updated 05 Jan 2016 |
| 31 Mar 2007 | Trial Update | EmphyCorp completes a phase I trial in Cystic fibrosis in USA (NCT00308243) Updated 05 Jan 2016 |
| 25 May 2006 | Trial Update | EmphyCorp completes a phase II trial in Chronic obstructive pulmonary disease in USA (NCT00262613) Updated 05 Jan 2016 |
| 31 Mar 2006 | Phase Change - I | Phase-I clinical trials in Cystic fibrosis in USA (Inhalation) Updated 05 Jan 2016 |
| 31 Jan 2006 | Phase Change - I/II | Phase-I/II clinical trials in Asthma in USA (Inhalation) Updated 05 Jan 2016 |
| 31 Dec 2005 | Regulatory Status | Sodium pyruvate inhalation receives Orphan Drug status for Cystic fibrosis in USA Updated 05 Jan 2016 |
| 31 Dec 2005 | Regulatory Status | Sodium pyruvate inhalation receives Orphan Drug status for Interstitial lung diseases in USA Updated 05 Jan 2016 |
| 30 Sep 2004 | Phase Change - II | Phase-II clinical trials in Chronic obstructive pulmonary disease in USA (Inhalation) Updated 05 Jan 2016 |
References
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EmphyCorp N115 News: Reducing the Rate and Spread of COVID-19 with Nasal Nitric Oxide.
Media Release -
EmphyCorp News: As Reported in The Lancet - Clinical Features of Patients Infected with the 2019 novel Coronavirus in Wuhan, China.
Media Release -
Sodium Pyruvate Bronchodilation in Asthmatics.
ctiprofile -
Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease
ctiprofile -
Two Week Sub-chronic Double-blinded Placebo Controlled Trial Designed to Determine if Sodium Pyruvate Nasal Spray Will Reduce the Symptoms, Duration and Replication of COVID-19 and Influenza Infections
ctiprofile -
EmphyCorp News: Nitric Oxide is currently being tested in Clinical Trials as a Potential Treatment for Patients infected with the Coronavirus.
Media Release -
Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1
ctiprofile -
EmphyCorp N115 Rx Globally Patented Non-Steroidal Nasal Spray with No Known Side Effects for Pregnant Women with Allergic Rhinitis or Asthma.
Media Release -
EmphyCorp Inc. Non-Steroidal N115 Nasal Spray Completed Phase III Clinical Trial for COVID-19, Long COVID-19 (Long Haulers), and Pulmonary Fibrosis.
Media Release -
Preliminary Examination of the Effects of Sodium Pyruvate Nasal Spray (N115) on Symptoms Associated With COVID19 Long Haulers
ctiprofile
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