- Adhera to acquire and develop MLR-1019 (armesocarb), the API in mesocarb – a drug previously sold in Europe for 37 years – for Parkinson’s Disease
- MLR-1019, a Phase 2-ready product, could have substantial benefits over today’s Parkinson’s drugs, including being the first to address both movement and non-movement symptoms
Baton Rouge, LA, June 07, 2021 (GLOBE NEWSWIRE) -- Adhera Therapeutics, Inc. (OTCPK: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, is pleased to announce that the Company has signed a Letter of Intent (LOI) with Melior Pharmaceuticals II, LLC (“Melior Pharma 2”), pursuant to which Adhera will acquire MLR-1019 (armesocarb) from Melior Pharma 2. MLR-1019 is being developed as a new class of therapeutic for Parkinson’s disease (PD) and is, to the best of the Company’s knowledge, the only drug candidate today to address both movement and non-movement aspects of PD.
Armesocarb is the active pharmaceutical ingredient (API) of the racemic mixture mesocarb, a highly selective dopamine reuptake inhibitor first approved in the former Soviet Union in 1971 and marketed for select psychiatric and central nervous system (CNS) indications until 2008. At that time, which coincided with the Great Recession, the Russian manufacturer discontinued operations for business reasons unrelated to the compound itself.
Melior Pharma 2 was spun-out of Melior Discovery (“Melior”), an in vivo pharmacology-focused biopharmaceutical company, specifically for the purpose of advancing MLR-1019 for PD. Melior initially discovered the unexpected benefits of MLR-1019 in PD, subsequently securing the intellectual property with numerous patents. Years of use in more than one million psychiatric patients have established a strong safety profile for mesocarb across a wide therapeutic dosing range.
Based upon Melior’s work, a clear understanding of MLR-1019’s mechanism of action, abundant pre-clinical research and decades of clinical data on mesocarb, which is chemically related to armesocarb, Melior and Adhera believe that MLR-1019 represents a significant opportunity to address a large gap in therapeutics for PD. More specifically, MLR-1019 is expected to:
- Potentiate the anti-Parkinsonian activity of levodopa (L-DOPA), a drug commonly prescribed for controlling movement symptoms of Parkinson’s.
- Mitigate the L-DOPA-induced dyskinesia (PD-LID) associated with L-DOPA therapy more effectively than amantadine and without the unpleasant adverse events
- Address the excessive daytime sleepiness associated with PD
- Address attention and/or cognitive deficits associated with PD
“Everyone recognizes the devastating symptoms of Parkinson’s Disease, but many don’t realize that today’s approved drugs are woefully inadequate at addressing the full spectrum of the disease, often times exacerbating non-motor aspects,” said Andrew Kucharchuk, Chief Executive Officer at Adhera. “Today, PD patients and neurologists are forced into quality of life trade-offs related to disease management, debilitating effects of PD-LID, gastrointestinal and CNS side effects of amantadine and more. We are optimistic that MLR-1019 could be a tremendous value add to the PD market and patients in need worldwide.”
The LOI represents Adhera’s initiative to diversify its portfolio outside of oncology. Management is currently evaluating additional opportunities to further broaden the scope into other areas of unmet need with expedited pathways to commercialization. The Company is thrilled to call the Melior group of companies a strategic partner, particularly Melior Discovery, where there is an exciting pipeline of drug candidates being advanced through the early stages. Under the terms of the LOI, additional product opportunities, which are expected to arise outside of PD, will be available to Adhera.
The LOI require a definitive license agreement to be executed by July 31, 2021. Additional information on the LOI will be available on a Form 8-K which is being simultaneously filed with the Securities and Exchange Commission.
About Adhera Therapeutics
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). The Company has signed a Letter of Intent to acquire MLR-1019 (armesocarb) for Parkinson’s Disease from Melior Pharmaceuticals II, LLC and is actively exploring additional pipeline additions.
Melior Discovery and its sister 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.meliorpharma.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.
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