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Synergistic effect of EYP001 and IFN for treatment of HBV infection

A technology of EYP001 and synergistic effect, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, peptide/protein ingredients, etc., can solve the problem of low HBsAg loss rate, low HBVDNA inhibition rate, and drug resistance And other issues

Active Publication Date: 2022-02-15
ENYO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main limitations of interferon therapy are severe side effects, low HBV DNA suppression rate and low ALT normalization rate; the main limitations of direct antiviral drug therapy are: drug resistance; HBV replication rebound after stopping treatment, so long-term , lifelong treatment; HBsAg clearance is extremely low, thus increasing the risk of adverse events associated with prolonged, lifelong treatment
However, such a low rate of HBsAg loss makes a cure still elusive

Method used

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  • Synergistic effect of EYP001 and IFN for treatment of HBV infection
  • Synergistic effect of EYP001 and IFN for treatment of HBV infection
  • Synergistic effect of EYP001 and IFN for treatment of HBV infection

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Experimental program
Comparison scheme
Effect test

Embodiment

[0069] HBV chronic infection patients (male (n = 39) and women (n = 34)) received a 4-week course, in the study of the A portion (n = 48) as a separate therapy daily FXR agonist EYP001A or placebo Or Entecavir (ETV) or in combination with interferon (n = 23, injection of polyethylene glycolified IFNα2a, PEG-IFN). Patient characteristics: Average age 39.7 years (range: 19 to 63 years old); 6 people have 6 people in 73 people; 70% untreated; HBV DNA average baseline is 4.2 (± 1.5SD) log10 Iu / ml, HBsAg 3.5 (± 0.8sd) LOG10 IU / mL, and genotype A (25), B (8), C (10), D (7) and E (4). Tables 2 and 3 summarize detailed virological characteristics. The integration of FXR and all EYP001 doses caused C4, and FGF19 increased (data is not displayed).

[0070] At the end of day 29, 400 mg qd EYP001 reduced the average HBsAg by -0.1log10 Iu / mL (P figure 1 and figure 2 . QD has a stronger synergistic effect than BID.

[0071] Table 1

[0072]

[0073] Table 2: Summary of HBV infection par...

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Abstract

The present invention relates to a synergistic combination of EYP001 and interferon for the treatment of hepatitis B.

Description

Technical field [0001] The present invention relates to a method of treating hepatitis B infection. Background technique [0002] Hepatitis B is still a major global public health issue, although there are extensive vaccination programs, there are still more than 350 million chronic infected people. Chronic hepatitis B can evolve into complications that endanger life, including cirrhosis and cancer. The current treatment solution is long-term treatment (for example, using polymerase inhibitors for life; using polyethylene glycolized interferon for one year), because they are not targeted for viral storage libraries, it is still not cured HBV. HBV functional cure is still unmet to be a major medical needs. [0003] The main goal of chronic hepatitis B (CHB) treatment is to permanently inhibit HBV replication, and prevent or improve liver diseases. There are currently seven drugs available to treat CHB infection - conventional interferon (IFN), polyethylene glycolified interferon a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K47/60A61K31/496A61K45/06A61P31/20
CPCA61K31/496A61K38/212A61K47/60A61K45/06A61P31/20A61K2300/00A61K9/0019
Inventor 杰基·冯德舍伊莉斯·罗伊拉斐尔·达泰尔彼得罗·斯卡尔法罗
Owner ENYO PHARMA