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Adhera Therapeutics Expands Relationship with Melior Pharmaceuticals I, Adds NASH and Pulmonary Inflammation to Portfolio of Target Indications

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  • Adhera has an exclusive license agreement with Melior Pharmaceuticals I, pursuant to which Adhera is advancing MLR-1023 (tolimidone) into Phase 2 trials for Type 1 diabetes

  • The agreement has been expanded to allow Adhera to continue completed research of MLR-1023 for the areas of NASH and pulmonary inflammation

  • Adhera intends to explore abbreviated developmental pathways for these indications leveraging years of clinical data showing MLR-1023 is safe and well-tolerated

Baton Rouge, LA, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Adhera Therapeutics, Inc. (OTCPK: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, today announces that the Company has extended its relationship with Melior Pharmaceuticals I, Inc. (“Melior Pharma 1”) through the addition of exclusive development rights for two more indications to the existing licensing agreement covering MLR-1023 (tolimidone), one of the world’s only potent and specific lyn kinase activators. As disclosed on August 24, 2021, Adhera executed an exclusive license agreement with Melior Pharma 1 granting Adhera sole rights to develop MLR-1023 as a novel Phase 2-ready therapeutic for Type 1 diabetes.

Per the extended agreement, Adhera has been granted exclusive rights to advance development of MLR-1023 completed by Melior Pharma 1 for Non-Alcoholic Steatohepatitis (NASH) and pulmonary inflammation. The Company intends to explore abbreviated clinical trial opportunities for these indications based upon completed clinical trials including more than 700 patients treated with MLR-1023 defining strong safety and tolerability profiles.

Liver Disease: NASH

NASH is an advanced form of liver disease caused by buildup of fat in the liver of patients that consume little or no alcohol. The fat buildup causes inflammation that can lead to scarring of the liver and progress to cirrhosis, liver failure, liver cancer and death. It is a leading cause of liver transplants in the US afflicting more than 6 million adults1. There are currently no drugs approved by the U.S. Food and Drug Administration for treating NASH. Relative to MLR-1023, there is a growing body of promising work published on the relation of lyn kinase in liver regeneration. Allied Market Research forecasts the global NASH market to surge at a 58.4% compound annual growth rate to reach $21.48 billion by 2025.2

In animal models of NASH / liver fibrosis (the formation of scar tissue in the liver) conducted by Melior, MLR-1023 has produced compelling data to date, including:

  • Improvement in NAFLD (Non-alcoholic fatty liver disease) Activity Score, or NAS

  • Decreased liver weight

  • Reduction in steatosis

  • Improved insulin sensitivity

  • Anti-fibrotic activity

  • Reduction in adiposity

Other research on MLR-1023 by independent investigators has revealed modulation of lipid pathways to reduce fat accumulation in the liver and improved cell survival and hepatocellular regeneration, lending further evidence that clinical studies are warranted for the indication.

Pulmonary Inflammation

Independent research has demonstrated that lyn kinase plays a critical role in endothelial integrity and strengthening the endothelial barrier junction. Melior Pharma 1 has completed testing in animal models of pulmonary edema, a condition where fluid accumulates in air sacs of the lungs, with promising results that could be applicable in drug development for an array of diseases and conditions, such as SARS (Severe Acute Respiratory Syndrome) infections, influenza and sepsis, to name a few. Over the past 18 months, a “cytokine storm,” a serious condition where infection triggers the immune system to flood the bloodstream with inflammatory proteins (cytokines), has come into the mainstream purview because of its damaging effect in COVID-19, for which pulmonary edema is a leading cause of death. Melior Pharma 1’s research in this area is thought to be foundational as a proof of concept for future iterations of coronavirus, as well as other serious infections.

Melior Pharma 1 research on MLR-1023 as an oral medication in animal models has demonstrated:

  • Reduced pulmonary edema in a mouse model of cytokine storm

  • A long-lasting benefit to the pulmonary barrier

  • No disruption in immune response

  • Reduced deaths in mouse models of influenza

  • Reduced pulmonary edema in mouse models of influenza

Management Comments

MLR-1023 has been extensively studied as a new therapeutic for diabetes, a metabolic disease. NASH is also a metabolic disease where, much like diabetes, lyn kinase expression could be an ideal pathway to developing next-generation treatments.

Regarding pulmonary edema, MLR-1023 is clearly differentiated from commonly used therapeutics today, including anti-inflammatory drugs and vaccines. Unlike anti-inflammatory drugs that can suppress the immune response and exacerbate disease progression if administered at an inappropriate time, MLR-1023 is not a threat to interfere with the innate immune response. Contrary to vaccines, which are often specific to a particular virus, MLR-1023 has the potential to be used broadly with altered viral strains, as well as appearing to be well-suited for prophylactic purposes relative to pulmonary complications.

“MLR-1023 is a remarkable compound that positions us to address some largely unattended, yet immense markets, including diabetes, NASH, and the swath of maladies where pulmonary edema is a problem, starting with infections with the potential to explore cardiovascular diseases in the future,” said Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “We are thrilled to have a partner in Dr. Andrew Reaume and his team at the Melior family of companies and look forward to shepherding all their exciting work to the next stage of development.”

1 https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/nonalcoholic-steatohepatitis-information-center/nash-definition-prevalence/
2 https://www.alliedmarketresearch.com/nonalcoholic-steatohepatitis-NASH-market

About Adhera Therapeutics

Adhera Therapeutics is a clinical stage biopharmaceutical company focused on identifying advanced drug candidates that may qualify for accelerated developmental pathways. The Company has recently licensed two drug candidates, MLR-1019 and MLR-1023, from the Melior Discovery family of companies. Adhera is developing MLR-1023 (tolimidone) as a new drug for Type I diabetes with a focus on C-peptide positive patients. Adhera also has exclusive rights to develop MLR-1023 for Non-Alcoholic Steatohepatitis (NASH) and pulmonary inflammation diseases and conditions. MLR-1023, a lyn kinase activator, has demonstrated exceptional clinical safety and tolerability in over 700 patients in Phase 2a and Phase 2b Type 2 diabetes studies. MLR-1019 (armesocarb) is a new class of drug for Parkinson’s Disease (PD) and represents the only drug to address both movement and non-movement symptoms of PD. Armesocarb is the active enantiomer in mesocarb, a drug marketed in Europe for 37 years for various psychiatric and central nervous system indications. In addition to advancing both drug candidates in Phase 2 clinical trials, the Company remains active in exploring other advanced drug development opportunities while maintaining its legacy assets, including CEQ508, an oral delivery of small interfering RNA (siRNA) against beta-catenin, to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (FAP).

About Melior

Melior Discovery and its companies, Melior Pharmaceuticals I, Inc. and Melior Pharmaceuticals II, LLC, are leaders in pharmaceutical drug repositioning using the unique theraTRACE® platform comprised of multiplexed in vivo disease models. Melior is using these capabilities to build an internal pipeline of development candidates and also partners with pharmaceutical and biopharmaceutical companies to apply the theraTRACE® platform and its in-depth in vivo pharmacology expertise to their development candidates. Melior Discovery and Melior Pharmaceuticals are privately held and located in Exton, PA. For more information, visit www.meliordiscovery.com and www.Meliorpharmaceuticals.com.

Forward Looking Statements

This press release contains forward-looking statements as defined by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including the anticipated benefits of the compound, the initiation of Phase 2 trials, execution of the License Agreement, completion of a financing and the amount of proceeds, if any, from the con- templated financing and future collaborative opportunities. Forward-looking statements involve risks, uncertainties and assumptions that could cause Adhera Therapeutics' actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Adhera Therapeutics has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Adhera Therapeutics' need for, and the availability of, substantial capital in the future to fund its operations and research and development, the ability to agree upon the terms of the proposed financing with potential investors and existing noteholders and close on it, general risks in obtaining approval to initiate clinical trials, safety or efficacy issues arising during the trials, and the ultimate risks in reaching the commercialization stage. A more complete description of these risk factors is included in Adhera Therapeutics filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Adhera Therapeutics undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

INVESTOR AND MEDIA CONTACT:
Adhera Therapeutics, Inc.
Andrew Kucharchuk
Chief Executive Officer
akucharchuk@adherathera.com


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