Adhera Therapeutics Signs Exclusive License Agreement with Melior Pharmaceuticals I for New Type 1 Diabetes Drug Candidate
August 24, 2021 at 06:50 pm IST
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Adhera Therapeutics, Inc. announced that the company has executed an exclusive license agreement with Melior Pharmaceuticals I, Inc. defining the terms and conditions for which Adhera will license MLR-1023 (tolimidone) from Melior Pharma 1 for the purpose of developing a novel therapeutic for Type 1 diabetes. 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. Adhera will focus its initial clinical trials on patients with Type 1 diabetes where the Company can benefit from a number of factors, including the existing safety profile to move directly into Phase 2 clinical trials, a shorter and less expensive clinical pathway compared to Type 2 diabetes, independent research demonstrating a robust therapeutic effect by MLR-1023 in a Type 1 diabetes animal model, and large addressable market due to the lack of alternative treatment options in Type 1 diabetes aside from insulin injections or an insulin pump. In Type 1 diabetes patients, the pancreas produces little to no insulin. At a cellular level, the immune system attacks pancreatic beta cells that produce insulin, leaving the patient with deficient levels of insulin to control blood glucose and dependency upon exogenous insulin. Approximately 20-30 percent of Type 1 diabetes patients have demonstratable amounts of beta cell mass as determined by detectable amount of the insulin synthesis byproduct, C-peptide. Research indicates the potential for MLR-1023 to induce proliferation of a patient’s remaining beta cells. Melior and Adhera hypothesize that if the beta cell mass can be expanded in the C-peptide positive patient population, it may be possible to either reduce or eliminate the exogenous insulin requirement.
Adhera Therapeutics, Inc. is a specialty biotech company. The Company is focused on the drug development and commercialization of small molecule drugs to treat Parkinson's disease (PD) and Type 1 diabetes. The Company's advanced development programs are MLR-1019, a small molecule drug candidate being developed for PD, and MLR-1023, being developed to treat Type 1 diabetes. MLR-1019 is a highly selective dopamine re-uptake inhibitor for treating the dyskinesias associated with chronic dopamine precursor levodopa (L-DOPA) treatment in PD patients. MLR-1019 is a highly selective dopamine reuptake transporter (DAT) inhibitor used for the treatment of type 1 diabetes, non-alcoholic steatohepatitis, and pulmonary inflammation. It utilizes a virtual drug development model, where contract research organizations (CROs) are employed to undertake certain drug discovery and development services on the Companyâs behalf and under its direct supervision.