Adhera Receives European Patent Covering MLR-1019 and Derivatives for Treating Dyskinesias

Baton Rouge, LA, Oct. 04, 2021 (GLOBE NEWSWIRE) — Adhera Therapeutics, Inc. (OTCPK: ATRX) (“Adhera” or the “Company”), a clinical stage biopharmaceutical company, is pleased to announce that a new European patent has been issued for MLR-1019 (armesocarb), a drug licensed by the Company from Melior Discovery (“Melior”) company Melior Pharmaceuticals II, LLC (“Melior 2”). Melior has received notice from the European Patent Office that the patent, titled, “Methods of Treating Dyskinesia and Related Disorders,” passed the required period without any opposition being filed, triggering the issuance of the patent.

The new patent adds to a growing patent estate protecting MLR-1019 now comprised of 11 issued patents (3 in U.S., Europe Union, Australia, Chinese, Eurasia, Israel, Mexico, South Africa, and Hong Kong) and 8 pending patents (U.S., Japan, Brazil, Canada, 2 in South Korea, New Zealand, and Singapore).

“Given that our development plans for MLR-1019 begin in Eastern Europe, the new patent is particularly timely as part of a robust patent portfolio protecting the intellectual property,” commented Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “Dyskinesias have a negative impact both functionally and socially on most Parkinson’s patients, causing embarrassment while inhibiting their ability for daily tasks, including writing, dressing, and eating. We certainly hope that MLR-1019 can one day provide some relief to this debilitating disease.”

Adhera will develop MLR-1019 as a new class of drug for Parkinson’s disease (PD) and, to the best of the Company’s knowledge, as the only drug candidate designed 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. Based upon previous work conducted by Melior 2, 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, 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.

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.

INVESTOR AND MEDIA CONTACT:
Adhera Therapeutics, Inc.
Andrew Kucharchuk
Chief Executive Officer
akucharchuk@adherathera.com