Adhera Therapeutics, Inc. announced 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. 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).