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Sodium pyruvate inhalation - EmphyCorp

Drug Profile

Sodium pyruvate inhalation - EmphyCorp

Alternative Names: EmphyClear COPD Oral Spray; EmphyClear COPD/Asthma Spray; N115; N115 Non-Steroidal Nasal Spray; Rx N115 non-steroidal nasal spray

Latest Information Update: 14 Apr 2020

At a glance

  • Originator Emphycorp
  • Class Antiasthmatics; Antifibrotics; Sodium compounds
  • Mechanism of Action Reactive oxygen species inhibitors
  • Orphan Drug Status

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

    Yes - Interstitial lung diseases; Cystic fibrosis
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Interstitial lung diseases
  • Phase II Asthma; Chronic obstructive pulmonary disease; Cystic fibrosis
  • Clinical Phase Unknown COVID 2019 infections
  • No development reported Lung disorders

Most Recent Events

  • 07 Apr 2020 EmphyCorp has patent protection for inhaled sodium pyruvate for the treatment of multiple diseases in USA before April 2020
  • 07 Apr 2020 EmphyCorp has patent protection for inhaled sodium pyruvate for the treatment of Viral infections
  • 07 Apr 2020 EmphyCorp has patent pending for inhaled sodium pyruvate for the treatment of Lung diseases in USA before April 2020

Development Overview

Introduction

EmphyCorp is developing an inhaled aerosol formulation of sodium pyruvate, a reactive oxygen species inhibitor, for the treatment of chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis, interstitial lung disease and prevention of Covid-2019 infections. Clinical development is underway in the US. Clinical trials in unspecified indications have been initiated in China.

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, Aerosol).

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

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] [5] .

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 [6] .

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 [7] .

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 Aerosol
  • Class Antiasthmatics, Antifibrotics, Sodium compounds
  • Target Reactive oxygen species
  • Mechanism of Action Reactive oxygen species inhibitors
  • WHO ATC code

    J05A-X (Other antivirals)

    R03B-X (Other drugs for obstructive airways diseases, inhalants)

    R07A-X (Other respiratory system products)

  • EPhMRA code

    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

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Asthma - - Phase II USA Inhalation / Aerosol Emphycorp 31 Dec 2013
COVID 2019 infections - Prevention Clinical Phase Unknown USA Inhalation / Aerosol Emphycorp 17 Mar 2020
Chronic obstructive pulmonary disease - - Phase II USA Inhalation / Aerosol Emphycorp 30 Sep 2004
Cystic fibrosis - - Phase II USA Inhalation / Aerosol Emphycorp 31 Dec 2013
Interstitial lung diseases for pulmonary fibrosis - Phase III USA Inhalation / Aerosol Emphycorp 12 Aug 2019
Lung disorders - - No development reported (Clinical) China Inhalation / Aerosol Emphycorp 04 Nov 2017

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

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 [7] .

In phase II/III trials, inhaled sodium pyruvate reduced nasal congestion and inflammation [1] .

Development History

Event Date Update Type Comment
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) [5] 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 [7] Updated 23 Jan 2020
12 Aug 2019 Trial Update EmphyCop completes phase III clinical trial for NDA marketing application in interstitial lung diseases [7] 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, Aerosol) Updated 04 Nov 2017
31 Dec 2013 Phase Change - Clinical Clinical trials in Lung disorders in China (Inhalation) Updated 06 Jan 2016
31 Dec 2013 Phase Change - II Phase-II clinical trials in Asthma in USA (Inhalation) Updated 06 Jan 2016
31 Dec 2013 Phase Change - II Phase-II clinical trials in Cystic fibrosis in USA (Inhalation) Updated 06 Jan 2016
31 Dec 2013 Phase Change - II Phase-II clinical trials in Interstitial lung diseases in USA (Inhalation) Updated 06 Jan 2016
24 Jun 2011 Trial Update EmphyCorp terminates a phase I/II trial in Asthma in USA (NCT00262652) Updated 06 Jan 2016
31 Mar 2007 Trial Update EmphyCorp completes a phase I trial in Cystic fibrosis in USA (NCT00308243) Updated 06 Jan 2016
25 May 2006 Trial Update EmphyCorp completes a phase II trial in Chronic obstructive pulmonary disease in USA (NCT00262613) Updated 06 Jan 2016
31 Mar 2006 Phase Change - I Phase-I clinical trials in Cystic fibrosis in USA (Inhalation) Updated 06 Jan 2016
31 Jan 2006 Phase Change - I/II Phase-I/II clinical trials in Asthma in USA (Inhalation) Updated 06 Jan 2016
31 Dec 2005 Regulatory Status Sodium pyruvate inhalation receives Orphan Drug status for Cystic fibrosis in USA Updated 06 Jan 2016
31 Dec 2005 Regulatory Status Sodium pyruvate inhalation receives Orphan Drug status for Interstitial lung diseases in USA Updated 06 Jan 2016
30 Sep 2004 Phase Change - II Phase-II clinical trials in Chronic obstructive pulmonary disease in USA (Inhalation) Updated 06 Jan 2016

References

  1. EmphyCorp N115 News: Reducing the Rate and Spread of COVID-19 with Nasal Nitric Oxide.

    Media Release
  2. EmphyCorp News: As Reported in The Lancet - Clinical Features of Patients Infected with the 2019 novel Coronavirus in Wuhan, China.

    Media Release
  3. Sodium Pyruvate Bronchodilation in Asthmatics.

    ctiprofile
  4. Long-Term Use of Inhaled Sodium Pyruvate for the Treatment of Chronic Obstructive Pulmonary Disease

    ctiprofile
  5. EmphyCorp News: Nitric Oxide is currently being tested in Clinical Trials as a Potential Treatment for Patients infected with the Coronavirus.

    Media Release
  6. Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1

    ctiprofile
  7. EmphyCorp N115 Rx Globally Patented Non-Steroidal Nasal Spray with No Known Side Effects for Pregnant Women with Allergic Rhinitis or Asthma.

    Media Release
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