Adhera Therapeutics Inc (ATRX)

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

https://www.globenewswire.com/news-release/2021/10/20/2317559/0/en/Adhera-Therapeutics-Expands-Relationship-with-Melior-Pharmaceuticals-I-Adds-NASH-and-Pulmonary-Inflammation-to-Portfolio-of-Target-Indications.html

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.”