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Publication Number
US-12138240-B2
Publication Date
2024-11-12
Expiration Date
Abstract
A method for treatment of cardiac dysfunction comprising administering to a subject in need thereof a therapeutically effective amount of at least one of ANAVEX 2-73 or ANAVEX 19-144 or a pharmaceutically acceptable salt thereof or a combination thereof.
Core Innovation
The invention relates to methods for treating a cardiac dysfunction in a subject in need thereof by administering ANAVEX 19-144, or a pharmaceutically acceptable salt thereof, and optionally administering a combination of ANAVEX 19-144 with ANAVEX 2-73. The methods are described in the context of shortening the subject’s QT interval relative to the QT interval before administration, wherein the QT interval shortening is specified as the shorter of about 10 ms and about 2% to about 3%.
The document references QT interval timing, QTc risk considerations, and torsades de pointes risk as motivations for QT interval assessment and control. QTcF, dQTcF, and ΔΔQTcF are described as part of evaluating QT interval behavior during exposure.
The document further supports the approach with human first-in-human ECG and pharmacokinetic exposure–QTcF modeling, including exposure–heart rate model elements and example clinical cases. The modeling is described as showing that QTcF does not prolong and tends to decrease or level off with exposure, and example clinical cases are provided for atrial fibrillation/flutter and ventricular fibrillation.
Claims Coverage
The provided claims include two independent claims. One covers treating a cardiac dysfunction via ANAVEX 19-144, optionally with ANAVEX 2-73, with a specified QT interval shortening magnitude; the other covers treating ventricular fibrillation via administration of ANAVEX 19-144. Across these independent claims, the key inventive features are QT interval shortening relative to baseline and targeted treatment of specified cardiac dysfunctions or ventricular fibrillation using ANAVEX 19-144, with an optional combination with ANAVEX 2-73 in the broader claim.
Treating a cardiac dysfunction by QT interval shortening with ANAVEX 19-144
Administer to a subject in need thereof a therapeutically effective amount of ANAVEX 19-144, or a pharmaceutically acceptable salt thereof, optionally in combination with ANAVEX 2-73, or a pharmaceutically acceptable salt, wherein the subject’s QT interval is shortened by the shorter of about 10 ms and by about 2% to about 3% relative to the subject’s QT interval before the administration.
Treating ventricular fibrillation with ANAVEX 19-144
Treat ventricular fibrillation in a subject in need thereof by administering to the subject an effective amount of ANAVEX 19-144.
The claim coverage is focused on administering ANAVEX 19-144 to achieve a specified degree of QT interval shortening versus baseline in the broader cardiac dysfunction method, with an additional independent claim directed specifically to ventricular fibrillation treatment using ANAVEX 19-144.
Stated Advantages
Shortens the subject’s QT interval relative to the subject’s QT interval before administration.
QTcF does not prolong and tends to decrease or level off with exposure.
No serious adverse events were reported in the example clinical cases described.
Documented Applications
Treatment of cardiac dysfunctions and arrhythmias including atrial fibrillation/flutter and ventricular fibrillation, supported by example clinical cases and ECG/PK exposure–QTcF modeling.
Treatment context includes ventricular fibrillation and cardiac dysfunction conditions relevant to QT interval and torsades de pointes risk assessment.
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