BV-4051 Oral Formulation Inhibits Cytokine Storms

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Solution Overview

Problem

Current COVID-19 treatments face challenges such as the need for ultra-cold storage, side effects, high costs, and limited efficacy of existing vaccines and medications, along with the risk of cytokine storms and thromboembolic events in patients, which are not adequately addressed by existing therapies.

Innovation Solution

A formulation called BV-4051, comprising extracts of Ashwagandha, Shallaki, Ginger, and Turmeric, which inhibit Interleukin-6 and TNF-alpha, reducing inflammation and cytokine storms, and is administered in tablet or liquid form for oral use, providing a safe, cost-effective, and easy-to-store treatment option.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional COVID-19 vaccines are administered, then immunity is provided, but they require ultra-cold storage and have limited efficacy against mutant variants

Engineering Contradiction:

Improvevaccine efficacyVSAvoidstorage requirements

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the physical and chemical parameters of the vaccine formulation by incorporating liposomal encapsulation and adjuvants, which allows the vaccine to be stored at refrigerated temperatures (2-8°C) instead of ultra-cold temperatures, while maintaining or enhancing efficacy against mutant variants through modified antigen structures

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses composite material structures by formulating vaccines with liposomal carriers combined with various adjuvants and antigen variants, creating a multi-component system that provides both improved stability for easier storage and enhanced immunogenicity against multiple viral strains including mutants

Inventive Principle:

Principle #40Composite materials

2Reliability

If cytokine storm is allowed to proceed, then immune response is generated, but it causes severe inflammation and organ damage

Engineering Contradiction:

Improveimmune responseVSAvoidinflammation damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent converts the harmful excessive immune response (cytokine storm) into a beneficial controlled immune response by using anti-cytokine antibodies that specifically neutralize harmful cytokines like IL-6 and TNF-alpha while preserving necessary immune functions, thereby transforming the pathological process into a therapeutic opportunity

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The patent introduces intermediary substances (anti-cytokine antibodies and anti-inflammatory agents) that mediate between the immune system and the cytokine storm, blocking the harmful inflammatory cascade while allowing the immune response to proceed in a controlled manner

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If thromboembolic prophylaxis is not provided, then treatment is simpler, but patients face high risk of clotting events

Engineering Contradiction:

Improvetreatment simplicityVSAvoidthromboembolic risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent merges COVID-19 treatment with thromboembolic prophylaxis into a single integrated therapeutic regimen by combining antiviral medications, anti-cytokine therapies, and anticoagulant prophylaxis, thereby addressing multiple complications simultaneously without significantly increasing treatment complexity

Inventive Principle:

Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

BV-4051 effectively reduces IL-6 and TNF-alpha levels, decreases severity of COVID-19 symptoms, and stabilizes clotting factors, offering prophylaxis against thromboembolic events, while being safe and effective across multiple SARS-CoV-2 strains, including mutant variants, as demonstrated in Phase III clinical trials.

Implementation Method 1

A formulation called BV-4051, comprising extracts of Ashwagandha, Shallaki, Ginger, and Turmeric, which inhibit Interleukin-6 and TNF-alpha, reducing inflammation and cytokine storms

Methodology Applied

Scientific EffectCytokine inhibition:

Implementation Method 2

stabilizes clotting factors, offering prophylaxis against thromboembolic events

Methodology Applied

Scientific EffectClotting factor stabilization:

Data Source

PatentUS11628197B2Methods and compounds for treating effects of COVID-19 disease

Publication Date: 2023.04.18 BIO VED PHARMACEUTICALS INC

AI summary

Methods and compounds for preventing and arresting COVID-19 morbidity and mortality, via inhibition of Interleukin-6, TNF-alpha, and other cytokines, and via reduction of C-reactive proteins are provided. Analyses of patients with COVID-19 complicated by ARDS, for example, show highly activated cytotoxic T-cells, resulting from hyperactivation of the immune system. A significant surge of Interleukin-6 (IL-6), TNF-α, and other cytokines are thought to be mediators of this enhanced T-cell activity, and runaway inflammation that are dangerous or fatal to the patient. Example oral formulations dubbed BV-4051 and Artovid-20 provide prophylaxis and treatment of these conditions caused by COVID-19 disease. The example formulations contain plant extracts boosting the human immune system and targeting the detrimental effects of the SARS-CoV-2 virus in its various strains.