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Compounds Used to Lower Uric Acid Levels

A uric acid level and compound technology, applied in drug combinations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as hepatotoxicity and acute liver failure

Active Publication Date: 2022-04-08
NEWSOARA BIOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, like many other drugs, benzbromarone may cause side effects of hepatotoxicity and acute liver failure

Method used

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  • Compounds Used to Lower Uric Acid Levels
  • Compounds Used to Lower Uric Acid Levels
  • Compounds Used to Lower Uric Acid Levels

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Example 1 Synthesis of compound I and its PDE4 inhibitory activity experiment

[0085] For the synthesis method of compound I and its PDE4 inhibitory activity test, please refer to the relevant description in the example of Chinese patent CN111808098B (paragraph [0082] on page 10-paragraph [0114] on page 14 of the specification).

Embodiment 2

[0086] The clinical trial of embodiment 2 compound I

[0087] 2.1 Clinical trial protocol design

[0088]

[0089]

[0090]

[0091]

[0092]

[0093]

[0094] 2.2 Results of clinical trials

[0095] The uric acid levels of the subjects in the single-dose group and the multi-dose group of Compound I changed as follows: Figure 1A (6 mg single dose and 10 mg single dose), Figure 1B (20 mg single dose and 30 mg single dose), figure 2 (10 mg multiple dose and 20 mg multiple dose), the results are also shown in Table 1.1, Table 1.2, Table 1.3 and Table 2.1, and Table 2.2, Table 2.3 and Table 2.4. Among them, Table 1.1, Table 1.2 and Table 1.3 show the changes in the uric acid level values ​​of the subjects in the single dose group (6 mg, 10 mg, 20 mg and 30 mg) before and after receiving Compound I treatment, Table 2.1, Table 2.2, Table 2.3 and Table 2.4 show the changes in the uric acid level values ​​of the subjects in the multi-dose groups (10 mg and ...

Embodiment 3

[0106] Example 3 Comparison of Compound I with other uric acid-lowering drugs

[0107] According to the clinical trial data of Example 2, based on the results of uric acid changes from baseline after 7 days of continuous administration of compound I at two different doses (10 mg and 20 mg) once a day, the inventors used the PK / PD model for compound I The uric acid-lowering effect of another four different doses (6 mg, 15 mg, 30 mg and 40 mg) administered once a day for 7 days was predicted. For specific results, please refer to image 3. Single-drug and combined use data of Recinard and febuxostat disclosed in the literature (see the literature Jacob Leander, Journal of Pharmacokinetics and Pharmacodynamics https: / / doi.org / 10.1007 / s10928-021-09747-y, and Figure 4 ) compared with the same or lower doses, Compound I showed better uric acid-lowering effects than single drugs of Resinald and febuxostat, and even achieved the same effect as the combination of Resinald and febuxos...

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Abstract

The application provides a PDE4 inhibitor (for example, a compound represented by formula (I)) or a pharmaceutically acceptable salt thereof) for use in reducing uric acid levels in individuals, preventing uric acid levels from increasing, treating, preventing or Use in a medicament for the alleviation of a disease, disorder or condition (eg, gout, hyperuricemia) associated with elevated levels of uric acid in an individual.

Description

technical field [0001] The present application relates to the field of disease treatment, in particular, the present application relates to PDE4 inhibitors (for example, 4-[1-(3-chlorophenyl)-7-methoxy-2,4-dioxo-pyrimido[5 ,4-c]quinolin-3-yl]cyclohexanecarboxylic acid or a pharmaceutically acceptable salt thereof) in the preparation for reducing uric acid levels in individuals, preventing uric acid levels from increasing, treating, preventing or alleviating Use in medicine for a disease, disorder or condition associated with elevated levels of uric acid (eg, gout, hyperuricemia). Background technique [0002] Hyperuricemia is caused by excessive production or insufficient excretion of uric acid and is considered a predisposing factor for several diseases that seriously affect quality of life. For example, hyperuricemia is considered a predisposing factor for gout, the most common form of inflammatory arthritis, which is characterized by severe joint pain and tenderness caus...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/519A61K45/06A61P19/06A61P7/00
CPCA61K31/519A61K45/06A61P19/06A61P7/00
Inventor 李元念陈瑾瑜朱清华朱倩
Owner NEWSOARA BIOPHARMA CO LTD
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