Enhanced Treatment of Cholestatic Diseases with Elafibranor
Legal Citation
Summary of the Inventive Concept
This inventive concept introduces novel methods and systems for treating cholestatic diseases, particularly PBC, by improving the efficacy, safety, and bioavailability of elafibranor, a promising therapeutic agent.
Background and Problem Solved
The original patent disclosed methods for treating pruritus associated with cholestatic diseases using elafibranor. However, the existing patent has limitations, such as variable bioavailability, potential side effects, and limited treatment options. The new inventive concept addresses these limitations by introducing controlled release systems, liposomal formulations, combination therapies, and personalized dosing strategies.
Detailed Description of the Inventive Concept
The new inventive concept comprises four key aspects: (1) a system for controlled release of elafibranor, ensuring prolonged efficacy while minimizing side effects; (2) a liposomal formulation to enhance bioavailability; (3) a combination therapy with a bile acid sequestrant to optimize therapeutic effects; and (4) a device for monitoring patient response and predicting treatment outcomes based on genetic markers. These innovations collectively improve the treatment of cholestatic diseases, offering patients more effective and personalized therapeutic options.
Novelty and Inventive Step
The new claims introduce novel and non-obvious solutions to the limitations of the original patent, including controlled release systems, liposomal formulations, and combination therapies. These innovations provide a significant improvement over the existing art, enabling more effective and efficient treatment of cholestatic diseases.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include different formulations, such as nanoparticles or microemulsions, or varying the ratio of elafibranor to bile acid sequestrant. Additionally, the monitoring device could be adapted for use with other therapeutic agents or diseases, expanding the scope of the inventive concept.
Potential Commercial Applications and Market
The enhanced treatment of cholestatic diseases with elafibranor has significant commercial potential in the pharmaceutical industry, particularly in the areas of gastroenterology and hepatology. The target market includes patients with PBC and other cholestatic diseases, as well as healthcare providers and pharmaceutical companies seeking more effective treatment options.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K31/192 |
| A | A61 | A61K45/06 |
| A | A61 | A61P37/06 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical medicine, specifically hepatology and drug delivery systems for treating cholestatic liver diseases, with expertise in drug formulation, pharmacokinetics, and targeted therapeutic interventions
Person of Ordinary Skill (PHOSITA) Profile
A medical researcher or pharmaceutical scientist with advanced degrees in pharmacology, medicinal chemistry, or related fields, possessing knowledge of liver disease treatments, drug delivery mechanisms, and therapeutic optimization strategies
Obviousness Rationale
A person having ordinary skill in the art would recognize that the published technical disclosure represents predictable variations and extensions of the source patent's core therapeutic approach. The proposed modifications to elafibranor's delivery, formulation, and administration represent standard pharmaceutical engineering techniques for improving drug efficacy and patient outcomes. These variations would be considered routine optimization strategies within the existing technological framework of cholestatic disease treatment.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,523 |
|---|---|
| Title | Methods of treatment of cholestatic diseases |
| Assignee(s) | Genfit |