Hinto Energy Acquires Novel Fibromyalgia Treatment IP

Rhea-AI Summary

Hinto Energy, Inc. (OTC:HENI) announced the acquisition of assets related to a novel treatment for fibromyalgia, JF-100, from JF BioPharma Inc. The agreement, dated March 6, 2023, involves the issuance of 1,000,000 shares of preferred C stock. JF-100 aims to address three root causes of fibromyalgia by modulating the endocannabinoid system, reducing oxidative stress, and enhancing mitochondrial energy production. A Phase 2 clinical study is planned to establish optimal dosing, leading to a subsequent Phase 3 trial. Global prevalence of fibromyalgia affects 4% of the population, predominantly women aged 20-50.

Positive

• Acquisition of novel treatment JF-100 potentially addresses significant unmet medical need in fibromyalgia.
• JF-100 targets multiple disease mechanisms, suggesting a comprehensive approach to treatment.
• Upcoming Phase 2 clinical study may pave the way for regulatory approval and future revenue growth.

Negative

• The acquisition is a related party transaction, which may raise concerns over governance and valuation.
• Success of JF-100 is uncertain, dependent on Phase 2 clinical trial outcomes and market competition.

SHERIDAN, WY / ACCESSWIRE / March 14, 2023 / HINTO ENERGY, INC. (OTC:HENI) today announced a transaction, dated March 6, 2023 to acquire certain assets related to a development stage, novel treatment for fibromyalgia for consideration of 1,000,000 shares of the Company's preferred C shares from JF BioPharma Inc., in a related party transaction.

Fibromyalgia syndrome (FMS) is a complex chronic multi-system disorder that affects 4% of the global population, mainly women aged 20-50 years. This intractable disease is characterized by diffuse musculoskeletal pain, fatigue, and depression. Without an effective therapy, FMS has a lifelong adverse impact on physical, social, and psychological well-being.

In order to address this important unmet medical need, JF BIOPHARMA has invented a novel proprietary pharmaceutical treatment ("JF-100") that simultaneously targets three distinct and fundamental root causes of the disease.

First, JF-100 is designed to directly modulate the endocannabinoid system in order to suppress the heightened sensitivity to pain that results from overactivation of a specific set of ion channels that transduce pain.

Second, JF-100 can suppress oxidant stress that can damage mitochondria, the key part of the cell that is responsible for ensuring sufficient energy is available to maintain normal organ function and mitigate fatigue and depression.

Lastly, JF-100 is designed to increase the efficiency of energy generation within the mitochondria, in order to maximize the level of cellular and organ activity for any given age and level of physical conditioning.

By addressing the breadth of the disorder and targeting all three biological disease mechanisms in parallel, the Company has designed JF-100 as a first-line agent for treatment of FMS.

Commenting on the utility of this combination approach, Dr. Andrew Salzman, the Company's Chief Scientist, remarked that "JF-100 can be viewed as a watershed advance in the treatment of FMS, because the drug is by design a multi-functional platform that addresses all three major mechanisms of disease. Customarily, treatments have been focused on a single aspect of FMS, and therefore have missed the opportunity to comprehensively address the full complexity of the disease process."

To advance JF-100 towards regulatory approval, JF BIOPHARMA intends to initiate a Phase 2 clinical study in patients with moderate to severe FMS. This study is expected to establish the optimal dose to be used in a subsequent national registration Phase 3 trial.

In preparation for the randomized, placebo-controlled, double blinded, Phase 2 clinical investigation, the Company plans to complete formulation research to optimally store and deliver JF-100 in an oral capsule.

This formulation research would be conducted under the direction of Dr. Andrew Salzman, in conjunction with the Salzman Group, a research institute based in Israel and Australia that has extensive experience in the invention and optimization of drugs regulating inflammation, pain, and cellular energetics.

The Phase 2 clinical studies are expected to be conducted in Australian centers specializing in FMS, under the leadership of Dr. Sud Agarwal at Ingenue Pty Ltd., a clinical research organization based in Melbourne, Australia.

About JF Biopharma, Inc.

JF Biopharma leverages a deep understanding of endocannabinoid biology to create and develop novel synthetic cannabinoid medicines for treatment of inflammation, metabolic disease, and burn trauma. The Company's clinical stage pipeline includes innovative proprietary therapeutics for management of fibromyalgia, Type 2 Diabetes, and wound healing. JF Biopharma is headquartered in New York City, with its preclinical research laboratory operations based in Katzrin, Israel, and its clinical research centers located in Melbourne and Sydney, Australia.

About Hinto Energy, Inc.

Hinto Energy is undergoing a transition of its business to biotechnology. Complete information may be found on the company's OTCMarkets Overview page.

Forward Looking Statements
Statements in this press release that are not historical fact may be deemed forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although Hinto Energy, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, Hinto Energy, Inc. is unable to give any assurance that its expectations will be attained. Factors or events that could cause our actual results to differ may emerge, and it is not possible for us to predict all of them. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Contact:
David Conkling, VP of Business Development
info@jfbiopharma.net

SOURCE: Hinto Energy, Inc.

View source version on accesswire.com:
https://www.accesswire.com/743642/Hinto-Energy-Acquires-Novel-Fibromyalgia-Treatment-IP

FAQ

What is the significance of Hinto Energy's acquisition of JF-100?

The acquisition allows Hinto Energy to enter the biotechnology sector with a focus on treating fibromyalgia, addressing a substantial market need.

How does JF-100 work in treating fibromyalgia?

JF-100 modulates the endocannabinoid system, reduces oxidant stress, and increases mitochondrial energy efficiency, targeting multiple disease mechanisms.

What are the next steps for Hinto Energy regarding JF-100?

Hinto Energy plans to initiate a Phase 2 clinical study to establish optimal dosing for JF-100, aiming for a Phase 3 trial thereafter.

What is the market potential for the treatment of fibromyalgia?

Fibromyalgia affects approximately 4% of the global population, indicating a significant market opportunity for effective therapies.

When will the Phase 2 clinical study for JF-100 begin?

The timing for the Phase 2 clinical study has yet to be specified, but it is expected to progress towards regulatory approval.