- Adhera to develop MLR-1019 (armesocarb) as a new class of drug for Parkinson’s Disease (PD), representing 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
- Companies expect to leverage existing safety and related data to move MLR-1019 directly into a Phase 2a clinical trial
Baton Rouge, LA, July 29, 2021 (GLOBE NEWSWIRE) -- Adhera Therapeutics, Inc. (OTCPK: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, is pleased to announce that, pursuant to a letter of intent disclosed June 7, 2021, the Company has executed a definitive license agreement (the “Agreement”) with Melior Pharmaceuticals II, LLC (“Melior Pharma 2”) defining the terms and conditions for which Adhera will license MLR-1019 (armesocarb) from Melior Pharma 2, for the initial purpose of developing a new therapeutic for Parkinson’s disease (“PD”).
Adhera believes that leveraging decades of safety data and previous work conducted by Melior Discovery (“Melior”), an in vivo pharmacology-focused biopharmaceutical company and parent company of Melior Pharma 2, will qualify advancing MLR-1019 directly into a Phase 2a clinical trial for PD. To the best of either companies’ knowledge, MLR-1019 will be the only drug candidate in development that addresses both movement (e.g., facial masking, dyskinesia, etc.) and non-movement (e.g., sleep disorders, cognitive deficits, etc.) symptoms of PD.
Armesocarb is the active enantiomer of the racemic mixture mesocarb, a highly selective dopamine reuptake inhibitor first approved in the former Soviet Union in 1971. Mesocarb was marketed for certain psychiatric and central nervous system (CNS) indications until 2008, at which time the Russian manufacturer of mesocarb discontinued operations for reasons unrelated to the compound. The compound has a well-documented safety profile undergirded by use in more than one million patients across a wide therapeutic dosing range during its time on the market.
In its research, Melior discovered the unexpected benefits of MLR-1019 for PD, subsequently securing the intellectual property (“IP”) with several patents. 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. Specifically, it is theorized that MLR-1019 can potentiate the anti-Parkinsonian activity of levodopa (L-DOPA), a drug commonly prescribed for controlling movement symptoms of Parkinson’s and mitigate the L-DOPA-induced dyskinesia (PD-LID) associated with L-DOPA therapy more effectively than amantadine and without the unpleasant adverse events.
“MLR-1019 represents what could be a huge step forward in the field of Parkinson’s disease insomuch that we’re optimistic it can provide patients relief for both movement and non-movement symptoms,” said Andrew Kucharchuk, Chief Executive Officer at Adhera. “We are thrilled to have the Melior group of companies as partners and collaborators on this project and look forward to evaluating MLR-1019 in a clinical setting with the goal of delivering a safe and effective option to patients and neurologists to better manage this debilitating disease.”
"We are delighted the Agreement and to be working with the Adhera team, as we have a shared vision towards armesocarb as an innovative new therapy to address multiple aspects of Parkinson’s disease,” said Andrew Reaume, CEO of Melior. “Our full set of global resources are now at the disposal of Adhera and we look forward to deepening our relationship based upon the success of our work in PD.”
Per the Agreement, Adhera will be granted exclusive worldwide rights to the MLR-1019 IP and Melior know how to develop MLR-1019 in exchange for payments that are only triggered by successful completion of specific clinical trial and FDA approval milestones. Melior will also be owed a royalty on all future gross product sales should MLR-1019 reach commercialization.
Additional information on the Agreement will be available on a Form 8-K which will be filed immediately 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). In addition to MLR-1019 (armesocarb), the Company is actively exploring additional pipeline additions.
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.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.
INVESTOR AND MEDIA CONTACT:
Adhera Therapeutics, INC
Andrew Kucharchuk
Chief Executive Officer
akucharchuk@adherathera.com