Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor

A technology for type 1 diabetes and hypercholesterolemia, which is applied in the field of diabetic patients and can solve the problems of incomplete understanding of the efficacy and safety of alirixumab

Pending Publication Date: 2020-03-24
SANOFI BIOTECH SAS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although anti-PCSK9 antibodies have been extensively studied clinically, the eff

Method used

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  • Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor
  • Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor
  • Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0344] Example 1: Generation of human antibodies against human PCSK9

[0345] Human anti-PCSK9 antibodies were generated as described in US Patent No. 8,062,640. An exemplary PCSK9 inhibitor used in the following examples is the human anti-PCSK9 antibody designated "mAb316P", also known as "REGN727" or "alirocumab". mAb316P has the following amino acid sequence characteristics: a heavy chain comprising SEQ ID NO:5 and a light chain comprising SEQ ID NO:9; a heavy chain variable region (HCVR) comprising SEQ ID NO:1 and a heavy chain comprising SEQ ID NO:6 Light chain variable region (LCVR); heavy chain complementarity determining region 1 (HCDR1) comprising SEQ ID NO:2, HCDR2 comprising SEQ ID NO:3, HCDR3 comprising SEQ ID NO:4, comprising SEQ ID NO:7 Light chain complementarity determining region 1 (LCDR1), LCDR2 comprising SEQ ID NO:8 and LCDR3 comprising SEQ ID NO:10.

Embodiment 2

[0346] Example 2: Randomized, double-blind, placebo-controlled parallel group study to evaluate alirixumab in patients with type 1 or type 2 diabetes mellitus not adequately controlled on maximally tolerated LDL-C lowering therapy Efficacy and safety of insulin-treated patients with hypercholesterolemia at high cardiovascular risk

[0347] introduce

[0348] More than 380 million people worldwide live with diabetes, most of whom will die from cardiovascular disease (CVD). Compared with people without diabetes, those with diabetes are at higher risk of developing CVD, suffer from associated clinical complications and at an earlier age, and have a shortened life expectancy of about 6 to 7 years. In addition to the high in-person costs of the disease, CVD contributes significantly to the overall healthcare expenditure of these patients.

[0349] The study, named Odyssey DM-Insulin, included adult patients with type 1 or type 2 diabetes on insulin therapy who, with or without ot...

Embodiment 3

[0739] Example 3: Analysis of Individuals with Type 2 Diabetes and ASCVD from the Odyssey DM-Insulin Clinical Trial

[0740] Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol, which consist of low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and low-density lipoprotein particle number (LDL-PN) reflected. The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events.

[0741] In this analysis, we assessed the efficacy and safety of alirocumab in individuals with T2DM, high LDL-C, or non-HDL-C, and identified patients receiving maximally tolerated statins in the DM-insulin study. Class ASCVD. DM-insulin study participants with ASCVD and T1DM were not included in this analysis because of the low number of individuals in this group (alicumab: n=11; placebo: n=5). As used in this example, ASCVD was defined as cor...

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Abstract

Provided are methods for treating high cardiovascular risk patients with hypercholesterolemia and type 1 or type 2 diabetes mellitus receiving insulin therapy. These methods generally comprise administering to a patient a pharmaceutical composition comprising an antibody or antigen binding fragment, thereof, which specifically binds hPCSK9 antibody, in combination with insulin therapy.

Description

[0001] related application [0002] This application claims U.S. Provisional Patent Application No. 62 / 517,672, filed June 9, 2017, U.S. Provisional Patent Application No. 62 / 532,162, filed July 13, 2017, and European Patent Application, filed May 4, 2018 Benefit of priority of application number 18305565.6. The content of each of these related applications is hereby incorporated by reference in its entirety. [0003] field of invention [0004] The present invention relates to the field of therapeutic treatment of diseases or conditions associated with elevated levels of lipids or lipoproteins. More specifically, the invention relates to PCSK9 inhibitors for the treatment of diabetic patients with hyperlipidemia, including hypercholesterolemia. Background technique [0005] Hyperlipidemia is a general term that includes diseases and conditions characterized by or associated with elevated levels of lipids and / or lipoproteins in the blood. Hyperlipidemia includes hyperchole...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K39/395C07K16/40A61K39/00
CPCA61K38/28A61K39/395C07K16/40A61K2039/505A61K2039/54A61K2039/545A61P3/06A61P3/10
Inventor M·布加斯-博巴诺维奇
Owner SANOFI BIOTECH SAS
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