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).

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.

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.