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Methods for treating hyperuricemia and related diseases

一种高尿酸血症、血清尿酸的技术，应用在泌尿系统疾病、骨骼疾病、医药配方等方向

Inactive Publication Date: 2013-08-14
ARDEA BIOSCIENCES INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is usually associated with an inherited abnormality in the body's ability to process uric acid, but can also be exacerbated by a diet high in purines

Method used

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  • Methods for treating hyperuricemia and related diseases
  • Methods for treating hyperuricemia and related diseases
  • Methods for treating hyperuricemia and related diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Research purposes

[0168] • Compare the proportion of subjects with sUA levels <6.0 mg / dL after 2 weeks of continuous treatment with drug 1 versus allopurinol and placebo.

[0169] • To evaluate the percent reduction from baseline in sUA levels after 2 weeks of continuous treatment with Drug 1 in combination with allopurinol.

[0170] • Evaluate the proportion of subjects with sUA levels <6.0 mg / dL, <5.0 mg / dL, and <4.0 mg / dL at each visit.

[0171] ●Evaluate the absolute and percent reduction in sUA levels from baseline at each visit.

[0172] • Evaluate the maximum percent reduction in sUA levels from baseline during the entire treatment period.

[0173] • Evaluate the percent change in 24-hour urine uric acid levels from baseline to Day 15.

[0174] • To evaluate the safety and tolerability of Drug 1 in subjects with gout.

[0175] • To evaluate the pharmacokinetics, safety and tolerability of Drug 1 in combination with allopurinol in subjects with gout.

[017...

Embodiment 2

[0357] Drug 1 was tested according to the clinical trial protocol described in Example 1.

[0358] The actual selection is as follows:

[0359] Cohort 1: 21 subjects - 11 randomly assigned to drug 1 group

[0360] -5 randomized to placebo group

[0361] -5 randomized to open-label allopurinol group

[0362] Group 2: 6 subjects - 5 randomly assigned to drug 1 + allopurinol group

[0363] -1 assigned to placebo + allopurinol group

[0364] Preliminary Safety Summary (Group 1 only)

[0365] Drug 1 was well tolerated in this study, with no SAEs, deaths, or discontinuations due to adverse events, and no clinically significant changes in physical examination results or vital signs. There were no clinically significant ECG findings (including interval measurements), and no increase in dose-related adverse events (all events were transient and mild to moderate in severity).

[0366] Two patients had a >30% increase in serum creatinine (SCr) when taking 400 mg QD (grade 1 AE), no...

Embodiment 3

[0372] According to the clinical trial protocol described in Example 1, BCX4208 (as 7-(((3R,4R)-3-hydroxy-4-(hydroxymethyl)pyrrolidin-1-yl)methyl)-3H-pyrrole [3,2-d]pyrimidin-4(5H)-one) was used instead of allopurinol to evaluate drug 1.

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Abstract

Provided herein are methods of treating gout, treating hyperuricemia, lowering serum uric acid, or the like with compounds of formula (I) have the following structure Further, provided herein are compositions comprising a compound of formula (I).

Description

Background technique [0001] Gout is a condition caused by the deposition of uric acid crystals in body tissues. It is usually associated with an inherited abnormality in the body's ability to process uric acid, but can also be exacerbated by a diet high in purines. Defective uric acid processing can lead to elevated levels of uric acid in the blood, which can lead to recurrent joint inflammation (arthritis), uric acid deposits in and around joints, decreased kidney function, and kidney stones. About 3-5 million people in the United States suffer from gout attacks, and the incidence rate of men is usually 6-9 times that of women (see Sanders and Wortmann, "Harrison's Principles of Internal Medicine", 16th edition; 2005; Food and Drug Administration (FDA) Advisory Committee Meeting, Terkeltaub presentation, June 2004; Terkeltaub, "Gout", NEngl J Med., 349, 1647-55, 2003). Contents of the invention [0002] In certain embodiments, provided herein are methods of treating gout ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61P13/12A61P19/02A61P1/16A61K31/426A61K31/4196
CPCA61K31/519A61K31/4196A61K31/426A61K2300/00A61P13/12A61P19/02
Inventor 巴里 D 夸特巴里·D·夸特
Owner ARDEA BIOSCIENCES INC
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