Effective Coronavirus Treatment and Prevention

Introduction

This innovative method for treating and preventing coronavirus infections provides a strategic approach to managing symptoms, reducing transmission, and enhancing immunity against variants of the coronavirus. By focusing on key pathways and mechanisms related to viral replication and immune response, this technology offers pharmaceutical companies and healthcare providers a versatile platform to develop effective treatment options that can be adapted to different viral strains. For companies engaged in infectious disease research and public health, this technology is an essential asset for advancing COVID-19 and related viral treatments, improving patient care, and supporting public health initiatives.

The Challenge: Combating Evolving Viral Threats

Coronavirus infections, particularly in light of the recent pandemic, have highlighted the need for adaptable and effective treatment solutions. As new variants of the virus emerge, existing treatments can struggle to keep up with the virus’s evolving nature, requiring healthcare providers and public health organizations to constantly update their strategies. The challenge is to develop methods that are not only effective against current strains but can also adapt to new ones. This demands treatments that target the underlying mechanisms of viral infection while bolstering the immune response to prevent spread and severity.

Advanced Methodology for Effective Coronavirus Treatment

This technology provides a comprehensive approach to addressing coronavirus infections by targeting the virus’s replication processes and enhancing immune defenses. The method leverages precise molecular interactions to reduce viral load and support the body’s natural immunity, making it effective for both treatment and prevention. By focusing on core mechanisms, this method ensures that treatments can remain effective even as new variants arise, offering a long-term solution to coronavirus management. The technology is adaptable for integration into vaccines, antiviral medications, or immune-boosting supplements, making it a versatile tool for healthcare providers.

Key Benefits for Pharmaceutical and Healthcare Sectors

For pharmaceutical companies, this technology offers a robust platform to develop a suite of products that address current and future needs in coronavirus treatment and prevention. Public health organizations and healthcare providers can integrate this method into their care protocols, providing patients with effective and reliable protection against coronavirus infections. Its adaptability also makes it valuable for rapid response to emerging viral threats, ensuring that healthcare systems are better equipped to handle surges in infection rates. This technology is a strategic asset for companies dedicated to advancing infectious disease management and strengthening global health security.

Invest in Public Health and Patient Safety

Licensing this coronavirus treatment and prevention technology positions your company as a leader in infectious disease solutions. By providing a flexible and powerful tool for managing and preventing coronavirus infections, your business can meet the growing demand for effective, adaptable treatments that protect public health. This technology is a strategic investment for companies committed to enhancing patient care, supporting pandemic preparedness, and leading in the field of viral infection management.

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Abstract
Claims

Provided herein are methods of using voclosporin for treating or preventing coronavirus infection, particularly in subjects that require immunosuppression.

1. A method of treating or preventing a virus infection in a subject, comprising administering to the subject a therapeutically effective amount of voclosporin.

2. The method of claim 1, wherein the subject is in need of immunosuppression.

3. The method of claim 1 or 2, wherein the virus infection is ameliorated by the inhibition of cyclophilin A (CypA) or a CypA associated pathway.

4. The method of any one of claims 1-3, wherein the virus infection is caused by a virus that is a member of Coronaviridae.

5. The method of claim 4, wherein the virus is an alphacoronavirus, a betacoronavirus, a deltacoronavirus, or a gammacoronavirus.

6. The method of claim 3 or 4 wherein the virus is Human coronavirus OC43 (HCoV-OC43), Human coronavirus HKU1 (HCoV-HKU1), Human coronavirus 229E (HCoV-229E), Human coronavirus NL63 (HCoV-NL63), Middle East respiratory syndrome-related coronavirus (MERS-CoV), Severe acute respiratory syndrome coronavirus (SARS-CoV), or Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

7. The method of any one of claims 3-6, wherein the virus is MERS-CoV, SARS-CoV, or SARS-CoV-2.

8. The method of any one of claims 3-7, wherein the virus is SARS-CoV-2.

9. The method of any one of claims 1-8, wherein the therapeutically effective amount is about 0.1 mg/kg/day to about 2 mg/kg/day.

10. The method of any one of claims 1-8, wherein the therapeutically effective amount is about 7.9 mg BID, about 15.8 mg BID, about 23.7 mg BID, about 31.6 mg BID, about 39.5 mg BID, about 47.4 mg BID, or about 55.3 BID.

11. The method of any one of claim 1-8, wherein the therapeutically effective amount is about 7.9 mg QD, about 15.8 mg QD, about 23.7 mg QD, about 31.6 mg QD, about 39.5 mg QD, about 47.4 mg QD, about 55.3 mg QD, about 63.2 mg QD, about 71.1 mg QD, about 79.0 mg QD, about 86.9 mg QD, about 94.8 mg QD, about 102.7 mg QD, or about 110.6 mg QD.

12. The method of any one of claim 1-8, wherein the therapeutically effective amount is equivalent to or can achieve a concentration of between about 0.05 μM and about 10 μM, about 0.1 μM and about 5 μM, about 0.2 μM and about 2.5 μM, about 0.3 μM and about 1.0 μM, about 0.4 μM and about 0.9 μM, about 0.5 μM and about 0.8 μM, about 0.1 μM and about 0.5 μM, or about 0.2 μM and about 0.4 μM, or about 0.05, about 0.1, about 0.15, about 0.2, about 0.25, about 0.3, about 0.35, about 0.4, about 0.45, about 0.5, about 0.55, about 0.6, about 0.7, about 0.8, about 0.9, about 1.0, about 1.5, about 2.0, about 2.5, about 3.0, about 3.5, about 4.0, about 4.5, about 5.0, about 6.0, about 7.0, about 8.0, about 9.0, or about 10.0 μM or less.

13. The method of any one of claims 1-12, wherein the renal function of the subject is monitored.

14. The method of claim 13, wherein monitoring the renal function of the subject comprises:

(a) assessing estimated Glomerular Filtration Rate (eGFR) of the subject at at least a first time point and a second time point on different days; and

(b) (i) if the eGFR of the subject decreases by more than a target % to below a predetermined value between the first and second time points, then reducing the daily dosage or stopping the administering of voclosporin to the subject;

(ii) if the eGFR of the subject decreases by less than the target % between the first and second time points, continuing administering the same daily dosage of voclosporin to the subject.

15. The method of claim 14, wherein the predetermined value is about 50 to about 90 ml/min/1.73 m².

16. The method of claim 14 or 15, wherein the predetermined value is about 60 ml/min/1.73 m².

17. The method of any one of claims 14-16, wherein the target % is about 20% to about 45%.

18. The method of any one of claims 14-17, wherein the target % is about 20%.

19. The method of any one of claims 1-18, wherein the subject has an autoimmune disease or a condition associated with transplant rejection.

20. The method of any one of claims 1-19, wherein the subject has a condition associated with transplant rejection.

21. The method of claim 19 or 20, wherein the condition is associated with heart, lung, liver, kidney, pancreas, skin, bowel, or cornea transplant rejection.

22. The method of any one of claims 19-21, wherein the condition is associated with kidney transplant rejection.

23. The method of claim 19, wherein the subject has an autoimmune disease.

24. The method of any one of claims 1-23, wherein the therapeutically effective amount of voclosporin is administered without administering a therapeutically effective amount of mycophenolate mofetil (MMF) and/or a therapeutically effective amount of a corticosteroid.

25. The method of any one of claims 1-23, further comprising administering a therapeutically effective amount of mycophenolate mofetil (MMF) and/or a therapeutically effective amount of a corticosteroid.

26. The method of any one of claims 1-25, wherein voclosporin is administered by enteral administration, oral administration, sublingual administration, or rectal administration, parenteral administration, intravenous injection, intramuscular injection, subcutaneous injection, intravenous infusion, or inhalation/insufflation.

27. The method of claim 26, wherein voclosporin is administered by enteral administration, oral administration, sublingual administration, or rectal administration.

28. The method of claim 25 or 27, wherein voclosporin is administered by oral administration.

29. The method of claim 26, wherein voclosporin is administered by parenteral administration, intravenous injection, intramuscular injection, subcutaneous injection, intravenous infusion, or inhalation/insufflation.

30. The method of claim 26 or 29, wherein voclosporin is administered by inhalation or insufflation.

31. The method of claim 30, wherein voclosporin is administered in the form of an aerosol.

32. The method of any one of claims 1-31, wherein voclosporin is administered in a pharmaceutical composition.

33. The method of claim 32, wherein the pharmaceutical composition comprises one or more pharmaceutically acceptable excipients.

34. The method of claim 33, wherein the pharmaceutically acceptable excipients are independently selected from one or more of comprising alcohol, D-α-tocopherol (vitamin E) polyethylene glycol succinate (TPGS), polysorbate 20 (Tween 20), polysorbate 40 (Tween 40), medium-chain triglycerides, gelatin, sorbitol, glycerin, iron oxide yellow, iron oxide red, titanium dioxide, and water.

35. The method of any one of claims 1-34, wherein the viral load is reduced in the subject following administration of voclosporin.

36. The method of any one of claims 1-35, wherein the survival of the subject is extended following administration of voclosporin.

Title

Methods of treating or preventing coronavirus infection

Inventor(s)

Y.K. Onno TENG, Robert B. HUIZINGA, Neil SOLOMONS, Jennifer Cross

Assignee(s)

Aurinia Pharmaceuticals Inc

Patent #

20230183293

Patent Date

June 15, 2023