Enhanced Treatment of Cholestatic Diseases with Elafibranor

Publication ID: 24-11857523_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Treatment of Cholestatic Diseases with Elafibranor,” Published Technical Disclosure No. 24-11857523_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857523_0006_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,523.

Summary of the Inventive Concept

The present inventive concept discloses direct improvements and enhancements to the original patent, focusing on optimizing elafibranor-based treatment regimens for cholestatic diseases, specifically Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).

Background and Problem Solved

The original patent disclosed methods of treatment of cholestatic diseases using elafibranor. However, it had limitations in terms of personalized treatment, dosing optimization, and risk reduction of adverse effects. The present inventive concept addresses these limitations by introducing novel components and approaches to enhance the efficacy and safety of elafibranor-based treatments.

Detailed Description of the Inventive Concept

The new inventive concept comprises a system for treating cholestatic diseases, which includes a monitoring module to track patient response to treatment and an adjustment module to adapt treatment regimens based on said response. Additionally, the concept involves a method for optimizing elafibranor dosing in patients with PBC by determining bile acid precursor C4 levels and adjusting the dosage accordingly. Furthermore, a composition for treating cholestatic diseases is disclosed, comprising elafibranor and a bile acid sequestrant, which enhances the efficacy of elafibranor. A system for personalized treatment of PBC is also introduced, utilizing a database of patient profiles and a treatment algorithm to recommend elafibranor dosing regimens. Finally, a method for reducing the risk of adverse effects associated with elafibranor treatment in patients with PBC is disclosed, involving monitoring liver enzyme levels and adjusting the dosage based on said levels.

Novelty and Inventive Step

The new inventive concept introduces novel components and approaches that are not obvious from the original patent, including the use of a monitoring module, adjustment module, bile acid precursor C4 levels, bile acid sequestrant, patient profile database, and treatment algorithm. These components and approaches provide a non-obvious solution to the limitations of the original patent, enhancing the efficacy and safety of elafibranor-based treatments.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different monitoring modules, such as wearable devices or mobile applications, to track patient response to treatment. Additionally, various adjustment modules could be used, such as machine learning algorithms or artificial intelligence systems, to adapt treatment regimens. Furthermore, different bile acid sequestrants could be used in the composition, and various treatment algorithms could be employed in the system for personalized treatment of PBC.

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 personalized medicine and treatment optimization. The target market includes patients with PBC and PSC, as well as healthcare providers and pharmaceutical companies seeking to improve treatment outcomes and reduce healthcare costs.

CPC Classifications

SectionClassGroup
A A61 A61K31/192
A A61 A61K45/06
A A61 A61P37/06

Field of Art

Pharmaceutical treatment of cholestatic liver diseases, specifically focusing on pharmacological interventions for Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC), with expertise in drug dosing, patient monitoring, and personalized medicine approaches

Person of Ordinary Skill (PHOSITA) Profile

A medical researcher or clinical pharmacologist with advanced training in hepatology, experience in drug development for liver diseases, knowledge of pharmacokinetics, patient response tracking, and personalized treatment strategies

Obviousness Rationale

A skilled practitioner would recognize that the PTD's variations represent logical extensions of the source patent's core treatment methodology for cholestatic diseases. The proposed monitoring, dosage adjustment, and combination strategies are natural progressions in personalized medical treatment that would be apparent to a researcher seeking to optimize elafibranor's therapeutic efficacy. These variations demonstrate standard approaches to refining pharmaceutical interventions through patient-specific monitoring and targeted dosage optimization.

Obvious Combinations & Variations

Source Patent Element
Method of treating PBC using elafibranor with oral administration
PTD Variation
Adding a monitoring module to track patient response and adjust treatment regimens
Obviousness Reasoning
Personalized medicine approaches are well-established, and monitoring patient response is a predictable method to optimize drug efficacy in chronic disease management
Source Patent Element
Elafibranor administration for cholestatic disease treatment
PTD Variation
Incorporating bile acid precursor C4 level monitoring for dosage adjustment
Obviousness Reasoning
Biomarker-guided dosing is a known technique in pharmaceutical treatment, representing a standard approach to optimizing therapeutic interventions
Source Patent Element
Composition for treating cholestatic diseases
PTD Variation
Adding a bile acid sequestrant to enhance elafibranor efficacy
Obviousness Reasoning
Combination therapies are common in pharmaceutical research, and identifying synergistic drug interactions is a predictable method of improving treatment outcomes
Source Patent Element
Oral administration of elafibranor for PBC treatment
PTD Variation
Implementing a patient profile database with treatment algorithm for personalized dosing
Obviousness Reasoning
Development of algorithmic treatment approaches is a standard progression in personalized medicine, representing an obvious extension of existing treatment methodologies
Source Patent Element
Method of treating PBC with elafibranor
PTD Variation
Monitoring liver enzyme levels to reduce adverse effect risks
Obviousness Reasoning
Safety monitoring is a fundamental aspect of pharmaceutical treatment, and adjusting dosage based on physiological markers is a well-established clinical practice
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. ยง 103, the variations disclosed in this publication would have been obvious to a person having ordinary skill in the art at the time of the invention, with a reasonable expectation of success, when considered in light of US Patent 11857523. The proposed modifications represent predictable variations within the established pharmaceutical research paradigm for cholestatic disease treatment, thereby rendering potential derivative claims obvious and unpatentable.

Original Patent Information

Patent NumberUS 11,857,523
TitleMethods of treatment of cholestatic diseases
Assignee(s)Genfit