α4β7 Antibody Multidose Regimens for Inflammatory Bowel Disease
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Solution Overview
Problem
Current integrin therapies, particularly those targeting α4β7, suffer from serious side effects and require frequent dosing to maintain therapeutic efficacy.
Innovation Solution
A multidose regimen involving a first and second injectable liquid formulation of α4β7 binding antibodies with specific amino acid sequences (SEQ ID NO: 1 and SEQ ID NO: 3) for treating inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, with dosages ranging from 500 mg to 1200 mg and 120 mg to 450 mg, respectively, administered intravenously or subcutaneously.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current integrin therapies are used to treat inflammatory bowel disease, then therapeutic efficacy is achieved, but serious side effects occur and frequent dosing is required
Solution Approach 1:
The patent applies parameter changes by modifying the dosing regimen parameters - using higher initial induction doses (400-600 mg) followed by lower maintenance doses (100-300 mg) administered less frequently (every 8-12 weeks). This changes the dosage parameters from the conventional frequent low-dose approach to a less frequent higher-dose approach, thereby maintaining therapeutic efficacy while reducing the frequency of administration and potentially reducing cumulative side effects
2Reliability
If current integrin therapies are used to treat inflammatory bowel disease, then therapeutic efficacy is achieved, but frequent dosing is required
Solution Approach 1:
The patent implements periodic action through a structured dosing regimen that consists of an induction phase with initial doses followed by a maintenance phase with doses administered at fixed intervals (every 8-12 weeks). This periodic dosing schedule allows the drug to accumulate to therapeutic levels during induction, then maintains those levels over extended periods during the maintenance phase, thereby reducing the overall dosing frequency while preserving therapeutic efficacy
Solution Approach 2:
The patent changes the dosing frequency parameter from conventional frequent dosing (every 2-8 weeks) to extended interval dosing (every 8-12 weeks). This parameter change is achieved by optimizing the balance between induction and maintenance doses, allowing the maintenance phase to sustain therapeutic levels for longer periods, thereby reducing the loss of time associated with frequent clinic visits and injections
Data Source
AI summary
Provided herein are variant α4β7 integrin antibodies and methods of use.