Method of treating enterovirus in chronic obstructive pulmonary disease patients

HK40138652APending Publication Date: 2026-10-09ALTESA BIOSCIENCES INC
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Patent Information

Application Number
HK62026126369
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-22
Filing Date
2026-07-20
Publication Date
2026-10-09
Estimated Expiration
2044-03-12

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Abstract

The present disclosure describes a method of treating a respiratory enterovirus infection in a human subject with COPD which includes administering to the subject a therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof, thereby treating the respiratory enterovirus infection in the subject. Pharmaceutical formulations of vapendavir are also disclosed.
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Description

This disclosure describes a method for treating a respiratory enterovirus infection in a human subject with COPD, comprising administering to the subject a therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof, thereby treating the subject's respiratory enterovirus infection. Pharmaceutical formulations of vapendavir are also disclosed. Abstract

Claims

CLAIMSWhat is claimed is:

1. A method of treating a respiratory enterovirus infection in a human subject with COPD comprising orally administering to the subject a therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof, thereby treating the respiratory enterovirus infection in the subject.

2. The method of claim 1, wherein the therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof is between about 250 mg and about 2,000 mg per day.

3. The method of claim 1, wherein the respiratory enterovirus is selected from a rhinovirus, echovirus, EV-68, EV-71, coxsackie virus, a non-polio enterovirus and combinations thereof.

4. The method of claim 1, wherein the therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof is a single loading dose of about 1,000 mg followed by a maintenance dose of about 500 mg every 12 hours for about 4 to about 10 days.

5. The method of claim 4, wherein the therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof is a single loading dose of about 1,000 mg per followed a maintenance dose of about 500 mg every 12 hours for a total of about 13 maintenance doses.

6. The method of claim 1, wherein the therapeutically effective amount of vapendavir or a pharmaceutically acceptable salt thereof is an amount that achieves a Cmax of about 2000 to about 12000 ng / ml.

7. The method of claim 1, wherein the subject is in a fed state.

8. The method of claim 4, wherein the single loading dose and maintenance dose are administered within about 30 minutes of the subject consuming a meal with solid food.

9. The method of claim 8, wherein administering the single loading dose and maintenance dose to a subject within about 30 minutes of the subject consuming a meal with solid food results in a higher plasma concentration of vapendavir or a pharmaceutically acceptable salt thereof than administering the single loading dose and maintenance dose to a subject in a fasted state.

10. The method of claim 1 , wherein the subject been diagnosed with GOLD stage 1 COPD, GOLD stage 2 COPD, GOLD stage 3 COPD, or GOLD stage 4 COPD.

11. The method of claim 1 , wherein the subject is receiving stable maintenance therapy for COPD.

12. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing a viral load in the sputum, nasal passages, or a combination thereof in the subject compared with a viral load in the sputum, nasal passages, or a combination thereof of the subject prior to treatment.

13. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing the subjects’ Evaluating Respiratory Symptoms in COPD Score (E-RS) compared to the subjects’ Evaluating Respiratory Symptoms in COPD Score (E-RS) prior to treatment.

14. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises preventing an increase in the subjects’ Evaluating Respiratory Symptoms in COPD Score (E-RS) compared to the subjects’ Evaluating Respiratory Symptoms in COPD Score (E-RS) score prior to treatment.

15. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing the subjects’ peak lower respiratory symptom score (LRSS) compared to the subjects’ peak lower respiratory symptom score (LRSS) prior to treatment.

16. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises preventing an increase in the subjects’ peak lower respiratory symptom score(LRSS) compared to the subjects’ peak lower respiratory symptom score (LRSS) prior to treatment.

17. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing the subjects’ peak upper respiratory symptom score (URSS) compared to the subjects’ peak upper respiratory symptom score (URSS) prior to treatment.

18. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises preventing an increase in the subjects’ peak upper respiratory symptom score (URSS) compared to the subjects’ peak upper respiratory symptom score (URSS) prior to treatment.

19. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing or preventing an increase in the subjects’ EXAcerbation of Chronic Pulmonary Disease Tool - Patient Reported Outcome (EXACT-PRO) compared to the subjects’ EXAcerbation of Chronic Pulmonary Disease Tool - Patient Reported Outcome (EXACT-PRO) prior to treatment.

20. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises decreasing or preventing an increase in the subjects’ EXAcerbation of Chronic Pulmonary Disease Tool - Patient Respiratory Symptoms (EXACT-RS) compared to the subjects’ EXAcerbation of Chronic Pulmonary Disease Tool - Patient Respiratory Symptoms (EXACT-RS) prior to treatment.

21. The method of claim 1 , wherein treating the respiratory enterovirus infection in the subject comprises preventing a decrease in the subjects’ lung function compared to the subjects’ lung function prior to treatment.

22. The method of claim 21, wherein the subjects’ lung function is measured by Forced Expiratory Volume -1 (FEV-i; in liters and % predicted), Forced Vital Capacity (FVC; in liters and % predicted) FEV i / FVC ratio and peak expiratory flow (PEF) or any combination thereof.

23. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ peak nasal lavage viral load compared to the subjects’ peak nasal lavage viral load prior to treatment.

24. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ peak sputum lavage viral load compared to the subjects’ peak sputum lavage viral load prior to treatment.

25. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ AUC nasal viral load compared to the subjects’ AUC nasal viral load prior to treatment.

26. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ AUC sputum viral load compared to the subjects’ AUC sputum viral load prior to treatment.

27. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing the duration of viral shedding.

28. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ peak sputum bacterial load compared to the subjects’ peak sputum lavage bacterial load prior to treatment.

29. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing or preventing an increase in the subjects’ AUC sputum bacterial load compared to the subjects’ AUC sputum bacterial load prior to treatment.

30. The method of claim 1, wherein treating the respiratory enterovirus infection in the subject comprises reducing the number of days wherein the subject is positive for bacteria in the sputum.