Adhera Therapeutics, Inc. announced that the company is to commence a dose finding study of MLR-1023 (tolimidone) in Type 1 Diabetes in collaboration with the Alberta Diabetes Institute (ADI) at the University of Alberta (U of A), located in Edmonton, Alberta, Canada. The company and U of A are finalizing the details of the trial, which are expected to be released shortly. The results of the study will also be utilized to optimize the dose range used in Adhera's forthcoming Phase 2 multi-center clinical trial of MLR-1023 in Type 1 Diabetes.

It is anticipated that the ADI will also participate in the multi-center study. MLR-1023, a lyn kinase activator with potent beta cell proliferation activity, 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 several factors, including the existing safety profile, which is expected to undergird the drug candidate moving directly into Phase 2 clinical trials and a shorter and less expensive clinical pathway compared to Type 2 Diabetes.

Independent research has demonstrated robust therapeutic effects of MLR-1023 in Type 1 Diabetes preclinical models. There is a 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 a resulting dependency on exogenous insulin. Approximately 20%-30% 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.

Adhera, alongside independent researchers, 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. In addition to the U of A trial, the company is pleased to inform shareholders that progress is being made towards filing an application to uplist to the NASDAQ, a milestone that should yield additional liquidity and allow the Company to secure financing for clinical trials for both MLR-1019 for Parkinson's Disease and MLR-1023 for Type 1 Diabetes.