Adhera Therapeutics Receives Notice of Allowance for New Canadian Patent Covering MLR-1019 for Dyskinesia and Related Disorders

Rhea-AI Summary

Adhera Therapeutics (OTCPK: ATRX) announced the issuance of a new Canadian patent for MLR-1019 (armesocarb), aimed at treating dyskinesia and related disorders. This expands its patent estate to 13 issued patents and 6 pending patents worldwide. Adhera plans to develop MLR-1019 as a unique therapy for Parkinson’s disease, addressing both movement and non-movement symptoms. The company will initiate a Phase 2a clinical trial in Eastern Europe and conduct IND-enabling studies in the U.S., leveraging extensive clinical data from similar compounds.

Positive

• Issuance of a Canadian patent for MLR-1019 enhances intellectual property protection.
• MLR-1019 is positioned as a unique therapy for Parkinson’s disease, addressing both movement and non-movement symptoms.
• Plans to initiate Phase 2a clinical trials in Eastern Europe and conduct IND-enabling studies in the U.S. leverage historical clinical data.

Negative

• None.

Baton Rouge, LA, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Adhera Therapeutics, Inc. (OTCPK: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, is pleased to announce that a new Canadian 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 a Notice of Allowance from the Canadian Intellectual Property Office for the patent, titled, “Methods of Treating Dyskinesia and Related Disorders.”

The patent estate protecting MLR-1019 domestically and internationally now consists of 13 issued patents (Canada, 3 in U.S., Europe Union, Australia, Chinese, Eurasia, Israel, Mexico, South Africa, South Korea, and Hong Kong) and 6 pending patents (U.S., Japan, Brazil, South Korea, New Zealand, and Singapore).

Adhera intends to 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 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. Adhera also has exclusive rights to develop MLR-1023 for Non-Alcoholic Steatohepatitis (NASH) and pulmonary inflammation diseases and conditions. 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 is believed by the Company to 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).

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

FAQ

What is the new patent issued for by Adhera Therapeutics (ATRX)?

Adhera Therapeutics has received a new Canadian patent for MLR-1019 (armesocarb), focusing on treating dyskinesia and related disorders.

How many patents does Adhera Therapeutics hold for MLR-1019?

Adhera Therapeutics now holds 13 issued patents and 6 pending patents for MLR-1019 globally.

When does Adhera Therapeutics plan to begin clinical trials for MLR-1019?

Adhera intends to start a Phase 2a clinical trial for MLR-1019 in an Eastern European jurisdiction.

What unique features does MLR-1019 have for Parkinson's disease treatment?

MLR-1019 is believed to be the only drug candidate designed to address both movement and non-movement symptoms of Parkinson's disease.

What is Adhera Therapeutics' plan regarding MLR-1019 development in the U.S.?

Adhera will conduct Investigational New Drug (IND)-enabling studies in the U.S. while leveraging extensive pre-existing clinical data.