Adhera Therapeutics Signs Exclusive License Agreement With Melior Pharmaceuticals I for New Type 1 Diabetes Drug Candidate

Adhera Therapeutics, Inc. recently announced it has executed an exclusive license agreement with Melior Pharmaceuticals I, Inc. defining the terms and conditions for which Adhera will license MLR-1023 (tolimidone) from Melior Pharma 1 for the purpose of developing a novel therapeutic for Type 1 diabetes.

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. Adhera will focus its initial clinical trials on patients with Type 1 diabetes where the company can benefit from a number of factors, including the existing safety profile to move directly into Phase 2 clinical trials, a shorter and less expensive clinical pathway compared to Type 2 diabetes, independent research demonstrating a robust therapeutic effect by MLR-1023 in a Type 1 diabetes animal model, and large addressable market due to the lack of alternative treatment options in Type 1 diabetes aside from insulin injections or an insulin pump.

In Type 1 diabetes patients, the pancreas produces little to no insulin. At a cellular level, the immune system attacks pancreatic beta cells that produce insulin, leaving the patient with deficient levels of insulin to control blood glucose and dependency upon exogenous insulin. Approximately 20%-30% of Type 1 diabetes patients have demonstratable amounts of beta cell mass as determined by detectable amount of the insulin synthesis byproduct, C-peptide. Research indicates the potential for MLR-1023 to induce proliferation of a patient’s remaining beta cells. Melior and Adhera hypothesize that if the beta cell mass can be expanded in the C-peptide positive patient population, it may be possible to either reduce or eliminate the exogenous insulin requirement.

“MLR-1023 could represent a major leap forward in diabetes care, particularly for the 320,000-480,000 people in the US expressing C-peptide that indicates they have residual levels of functional beta cells,” said Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “Researchers have for a number of years tried unsuccessfully to identify a safe and well tolerated agent that induces replication of human beta cells. MLR-1023 could be the first to do so. Clinical trials have demonstrated MLR-1023 as an insulin sensitizer and we greatly look forward to initiating a Phase 2 trial to evaluate it as an inducer of beta cell replication.”

The license agreement is the second between Adhera and the Melior family of companies. On July 29, 2021, Adhera announced a license agreement pursuant to which the company licensed MLR-1019 (armesocarb) from Melior Pharma 2, for the initial purpose of developing a new therapeutic for Parkinson’s disease. The company expects to provide additional updates on this initiative in the coming weeks.

According to the Juvenile Diabetes Research Foundation, approximately 1.6 million Americans are living with Type 1 diabetes, including about 200,000 youth (less than 20 years old) and 1.4 million adults (20 years old and older). By 2050, the prevalence is expected to rise to 5 million people in the US, including nearly 600,000 youth. There are $16 billion in Type 1 diabetes-associated healthcare expenditures and lost income annually in the US. Less than one-third of people with Type 1 diabetes in the U.S. are consistently achieving target blood-glucose control levels.

Adhera Therapeutics is a clinical stage biopharmaceutical company focused on identifying advanced drug candidates that may qualify for accelerated developmental pathways. Adhera’s legacy assets include 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). In addition to MLR-1019 (armesocarb), which is being developed for the treatment of Parkinson’s Disease, the company is actively exploring additional pipeline additions.

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.