Baton Rouge, LA, Oct. 15, 2021 (GLOBE NEWSWIRE) — Adhera Therapeutics, Inc. (OTCPK: ATRX) (“Adhera” or the “Company”), a clinical stage biopharmaceutical company, today announces that manufacturing has commenced of MLR-1019 (armesocarb) for use in the Company’s planned Phase 2a clinical trial as a new therapeutic for Parkinson’s disease (PD). Adhera is also pleased to inform shareholders that a new patent has been issued covering MLR-1019 in Korea.
Adhera is actively working to initiate a Phase 2a study designed to be a multi-center, double blind, randomized, placebo controlled clinical trial conducted in Eastern Europe to evaluate MLR-1019 as the only PD product under development that will address both movement and non-movement aspects of the disease. To the best of the Company’s knowledge, all existing agents that treat movement disorder, exacerbate non-movement disorder features of PD. Enrollment in the Phase 2 trial is expected to consist of Parkinson’s disease patients with L-DOPA induced dyskinesia, a commonly seen and potentially disabling movement side effect of treating PD with levodopa.
“Product manufacturing is a milestone for us as we move closer to initiating what we believe could be a landmark study in Parkinson’s disease treatments,” commented Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “Our development strategy is well informed because of the extensive history of mesocarb, which is chemically related to MLR-1019, in Europe, making the region an ideal setting for streamlining clinical research.”
Armesocarb is the active enantiomer in mesocarb, a drug marketed in Europe for 37 years for various psychiatric and central nervous system indications. Mesocarb has consistently been shown to be safe and well tolerated across a wide therapeutic dosing range as evidenced through treatment of more than one million patients and work published in 100+ publications. Based upon previous work conducted by the Company’s license partner, Melior Pharmaceuticals II, a clear understanding of MLR-1019’s mechanism of action, abundant pre-clinical research and decades of clinical data on mesocarb, Adhera intends to initiate a Phase 2a clinical trial in an Eastern European jurisdiction where mesocarb still has marketing registration. The Company will undertake a parallel process in the U.S. with Investigational New Drug (IND)-enabling studies. Adhera believes that the comprehensive historical data in combination with new data from clinical trials in Europe will facilitate an accelerated development pathway in the U.S.
Adhera has been notified of the issuance of a Certificate of Patent (Korean Patent No. 10-2301073) by the Korean Intellectual Property Office covering MLR-1019 in Korea. The (translated) title of the invention is: “A pharmaceutical composition comprising sydnocarb or a pharmaceutically acceptable salt thereof and method of treating dyskinesia and related disorders using the composition.”
The patent estate protecting MLR-1019 domestically and internationally now consists of 12 issued patents (3 in U.S., Europe Union, Australia, Chinese, Eurasia, Israel, Mexico, South Africa, South Korea, and Hong Kong) and 7 pending patents (U.S., Japan, Brazil, Canada, South Korea, New Zealand, and Singapore).
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. 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).
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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