“Another good weapon for the Covid arsenal would be a safe and effective drug that could be taken at home. Such outpatient drugs exist to prevent and treat the flu, and one public-health focus should be developing a Covid pill that could be taken after exposure or soon after symptoms appear, to stop the infection from progressing.”

-Dr. Scott Gottlieb, MD, and Mark McClellan, MD, PhD; Wall Street Journal, April 5, 2021

NED-260 COVID: A Multi-Pronged Approach to COVID-19

NED Biosystems™ is developing NED 260 COVID, an oral combination comprised of evidence-based agents. This product is designed to simultaneously broadly target at least four overlapping systemic processes integral to COVID-19 disease progression. 

NED-260 COVID is an oral, safe, affordable combination that has the potential to:

  • Allow COVID-19 patients to receive quality treatment while remaining safely at home.
  • Curtail the disruption caused by COVID-19 by reducing recovery time so that patients may return more quickly to family life and work.
  • Reduce risk of infection for those frequently exposed to COVID-19.
  • Be available for all populations, even those underserved.

COVID-19 Attacks the Body Via Four Distinct Processes:

NED-260 COVID is designed to simultaneously and redundantly target disease processes in multiple ways in order to achieve a synergistic therapeutic effect.

Rationale

Drugs being used experimentally to treat COVID-19 are narrowly focused on singular processes. COVID-19 will likely not be susceptible to just one medication, but rather will require multiple medications that affect multiple processes, similar to the treatment of TB or HIV. Each individual agent of NED-260 COVID has been selected to inhibit the virus and/or potentiate antiviral responses in the body. The proposed therapeutic effect of the combination is greater than that of any of the individual agents alone; it is this synergy of the individual agents that is intended to provide a broad antiviral therapeutic effect against COVID-19.

The main aims of this novel approach are:

  • To act ahead of or early in the disease process before damage occurs and to arrest the advancement to severe disease.
  • To administer persistently at low doses to improve tolerability and reduce the likelihood of adverse reactions.
  • To complement or replace what is currently being used. COVID-19 is currently being treated with antivirals, interleukin antibodies, or IVIG, and a more comprehensive approach is needed.

NED-260 COVID’s Mechanisms of Action Summarized:

  • Inhibit production of an array of interleukins, including IL-6
  • Elicit broad anti-inflammatory, antioxidant, and anti-thrombotic effects to suppress the cytokine storm that leads to ARDS
  • Proactively block viral entry into cells by promoting the shedding of the ACE2 receptor and inhibiting endocytosis
  • Inhibit viral polymerase and protease
  • Inhibit viral capsid formation
Three projected scenarios:

1. Virus infects the cell:

Viruses enter vulnerable cells in order to reproduce. The activated SARS-CoV-2 S protein binds to the ACE2 receptor on the cell surface, facilitating infection of the cell.

2. Virus is blocked:

NED-260 COVID may fortify cells by promoting the shedding of ACE2 receptors from the cell surface, which inhibits SARS-CoV-2 cellular entry.

3. Virus is contained:

In cells already infected, NED-260 COVID may promote breakdown and elimination of the infectious virus.

NED-260 COVID: Pre-Clinical Data

NED-260 COVID in vitro models of infection show:

  • High potency blockade of COVID-19 entry into cells
  • Inhibition of infectious spread of COVID-19
  • Active against variant strains of COVID-19
  • No toxicity signal in cellular assays

Ready to enter a Phase 2, double-blind, placebo-controlled, outpatient clinical trial, NED-260 COVID is designed to be the first comprehensive combination treatment/prophylaxis platform for COVID-19.

The Missing Critical Piece to the COVID-19 + Variants Puzzle: Oral Therapies

The COVID-19 pandemic has gripped America and the world in a medical, social, and economic crises, ushering in lockdowns and leading to severe economic slowdown globally.

Multiple new tactics will be essential to prevent and treat COVID-19 as economies reopen. With the uncertain threats new COVID-19 variants pose, NED-260 COVID is unlike any other COVID-19 treatment in development. Used to treat COVID-19 infection, the oral format requires no cold chain management or clinical infrastructure, allowing patients to treat their disease comprehensively and safely at home. In addition, pre-clinical evidence supports the use of NED-260 COVID as an oral prophylaxis for infection prevention, a desirable alternative for those with vaccine hesitancy, those who are immune compromised, and those who lack access to vaccines.

Most experts suggest that 70-80% herd immunity will be required to stem the Pandemic. Despite efforts since early 2021 to increase vaccinations for SARS-CoV-2, only 5.9% of the global population is vaccinated, and 42.6% in the U.S.[1] Without widespread vaccine or treatments in place, our health remains at risk as economies reopen.

A prophylactic and treatment is needed to ensure the safety of our communities, globally.

1Our World In Data, as of June 6, 2021