Baton Rouge, LA, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Adhera Therapeutics, Inc. (OTCPK: ATRX) ("Adhera" or the "Company"), a clinical stage biopharmaceutical company, today provides shareholders an update on corporate strategy and planned clinical development of MLR-1019 (armesocarb) and MLR-1023 (tolimidone). On July 29, 2021 and August 24, 2021, respectively, the Company announced executing exclusive license agreements for MLR-1019 for Parkinson’s disease (PD) and MLR-1023 for Type 1 diabetes.
Adhera will develop MLR-1019 as a new class of drug for 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 licensing partner Melior Pharmaceuticals II, LLC (“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.
MLR-1023, a lyn kinase activator, has demonstrated exceptional clinical safety and tolerability in over 700 patients in Phase 2a and Phase 2b clinical trials in patients with Type 2 diabetes. The Company will work under the IND of license partner Melior Pharmaceuticals I, Inc. (“Melior 1”) to continue clinical development of MLR-1023, with a transition to Type 1 diabetes as the target indication. The decision to focus on Type 1 diabetes was supported by multiple factors, including:
Compelling work by an independent investigator in Canada demonstrating the ability of MLR-1023 to confer unique benefits to pancreatic beta cell (insulin producing cells) in models of Type 1 diabetes.
Longer period of market exclusivity for Type 1 diabetes compared to Type 2 diabetes
Blue sky opportunity for an oral Type 1 diabetes drug (market for oral Type 2 diabetes drugs is already crowded)
Cost to market is substantially lower for Type 1 diabetes compared to Type 2 diabetes
On September 9, 2021, the Company announced the appointment of Andrew G. Reaume, Ph.D., MBA to the Company’s Board of Directors. Dr. Reaume is the President, CEO and Co-Founder of Melior Discovery, a pharmaceutical company specialized in in vivo disease models and drug repositioning, and the parent company of Melior 1 and Melior 2. Dr. Reaume, who earned his MBA from the Wharton School of the University of Pennsylvania and PhD in genetics from the University of Connecticut, has a deep understanding of MLR-1019 and MLR-1023 and will be instrumental in the next phases of clinical trials, as well as business development and adding additional accelerated drug candidates to the Adhera pipeline.
“We are very pleased about the positioning of our company today with two Phase 2-ready drug candidates indicated for extremely large market opportunities, as existing therapeutics for PD and Type 1 diabetes are lacking,” commented Andrew Kucharchuk, Chief Executive Officer at Adhera Therapeutics. “We are particularly excited about the pivot to Type 1 diabetes, which we model to positive Net Present Value (NPV), versus a flat NPV for Type 2. Given the dearth of oral medications for Type 1 diabetes, we are optimistic that we will garner attention from institutions and potentially large pharma as we advance our clinical work of MLR-1023.”
The Company is beginning the process to graduate to OTC Markets’ OTCQB marketplace. With the ultimate goal of a NASDAQ listing, Adhera sees the move to meet all OTCQB requirements as an important demonstration of management’s commitment to complete transparency, maximum exposure and building shareholder value.
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.
Chief Executive Officer
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