COVID-19

Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus

Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill and require medical attention. Older people and those with underlying medical conditions like cardiovascular disease, diabetes, chronic respiratory disease, or cancer are more likely to develop serious illness. Anyone can get sick with COVID-19 and become seriously ill or die at any age.

Solution and Treatment goals

Vaccines are not enough to control pandemic

Temporary Immunity

Need for Booster

Vaccination hesitancy

Efficacy variable, not 100%

Nebuliv

Reduction in viral load

Diminished risk of advanced disease

Reduced hospitalization

Short and Ambulatory treatment

Accessible

While coronavirus disease 2019 (COVID-19) is predominantly self-limited, up to 20% of symptomatic individuals will progress to severe or critical disease with clinical manifestations including pneumonia, acute respiratory distress syndrome, multiorgan system dysfunction, hypercoagulation, and hyperinflammatory manifestations. Morbidity and Mortality continue despite of global outreach preventative interventions.  Additionally, a growing body of data suggests that some patients with COVID-19, including individuals with mild symptoms, will have a variably prolonged course of recovery including fatigue, cognitive impairment, and cardiopulmonary dysfunction.  While treatment options for patients with severe disease requiring hospitalization are now available, interventions that can be administered early during the course of infection to prevent disease progression and longer-term complications are urgently needed

Asymtomatic or Presymtomatic

Positive SARS-CoV-2 test; no symptoms

Mild Illness

Mild symptoms (e.g., fever, cough, or change in taste or smell); no dyspea

Moderate Illness

Clinical or radiographic evidence of lower respiratory tract disease; oxygen saturation > 94%

  • 0 – 5 days EFFICACY
  • Antiviral therapy

Product Milestones

to-date

  • Nebuliv’s active ingredient, ivermectin, has shown efficacy to reduce viral replication of SARS-CoV-2 in vitro
  • However, systemic (through oral administration) delivery of ivermectin is insufficient to reach required concentrations for its antiviral activity, and reason why this molecule has not shown adequate efficacy in vivo
  • Using a known delivery system that will allow the active ingredient to reach upper and lower respiratory tissue in sufficient concentrations to reduce viral replication
  •  Completed double blind, randomized, placebo-controlled Proof-of-Concept study (NCT04595136), that demonstrated a statistically significant difference in the reduction of SARS-COV-2 viral replication measured by count of Sub-genomic Messenger RNA (sg MRNA) in the participants receiving ivermectin through nebulization when compared to nebulized SSN (as placebo) 
  • We are in the process of getting the paper published in an indexed scientific journal

Intellectual Property

The company is building a robust patent and IP portfolio to accompany its R&D and clinical pipeline.  We are also closely monitoring third-party patent rights in the same spaces to identify potential risks and opportunities.  

 A first patent family, directed to a nebulized ivermectin formulation for treating respiratory viral infections, including SARS-COV-2, was recently published (WO2021/234668).  The case is already under prosecution in the United States and some non-PCT countries.  

Over the course of the following months, Rivanima will file additional patent and industrial design applications to protect therapeutic indications, biomarkers and devices in the pipeline.

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