$ATRX Adhera Therapeutics Provides Insight on Corporate Strategy, Development of Parkinson’s Disease and Type 1 Diabetes Drugs
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.