Thermalin Selects Clinical Candidate for Stabilized, Ultra-Rapid and Concentratable Insulin Analog
Cleveland, Ohio, August 6, 2019 – Thermalin Inc., a privately held biotechnology company with its main laboratories in Cleveland, today announced that it has selected T-1123 as a clinical candidate for the treatment of patients with Type 1 (T1D) and Type 2 diabetes mellitus (T2D). T-1123 is a first-in-class, stabilized insulin analog that has an ultra-rapid time-action profile in both U-100 and U-500 formulations. These formulations demonstrate significantly improved resistance to potency loss through physical degradation compared to marketed insulin products.
Thermalin Chief Innovation Officer, Michael A. Weiss, M.D., Ph.D., M.B.A., said, “To create T-1123, Thermalin exploited general principles of protein design to tune critical molecular properties of insulin pertinent to its pharmacology: stability, self-assembly, mitogenicity, and potency.” Dod Michael, Ph.D., Chief Scientific Officer at Thermalin explained, “In pre-clinical studies we demonstrated (a) ultra-rapid insulin action for both U-100 and U-500 formulations of T-1123 in swine euglycemic clamp studies—results that are comparable with Novo Nordisk’s U-100 Fiasp®, (b) glucose-lowering potency of T-1123 in animal models that is comparable to human insulin and the prandial insulin analogs, (c) enhanced chemical and physical stability of T-1123, and (d) potency of T-1123 to stimulate proliferation of human MCF-7 breast cancer cells that is six-fold less than human insulin.” Weiss added, “We envision that both U-100 and U-500 formulations of T-1123 will address important, unmet needs among people with diabetes mellitus.”
The U-100 formulation of T-1123 will be compatible with existing insulin pumps, including durable tubed pumps and disposable patch pumps. Thermalin CEO Rick Berenson said, “This is of commercial interest because T-1123’s markedly augmented stability would allow for factory-filling of pump reservoirs before they are distributed to patients, eliminating the challenge these patients face in filling today’s pump reservoirs manually.” The U-500 ultra-rapid-acting formulation of T-1123, enables development of a miniaturized, pre-filled and disposable closed-loop glucose management system the size of a postage stamp—like Thermalin’s StampPump™. Additionally, minor modifications to existing factory-filled pen devices could support sufficiently accurate delivery of U-500 T-1123 to patients with severe insulin resistance who are required to take very large and thus painful bolus doses of insulin. Dr. Weiss commented, “This latter subset of T2DM patients disproportionately includes underserved minorities and the rural poor of Appalachia—populations with reduced life spans in an otherwise affluent society often due to the challenges they face maintaining good glycemic control with current insulins.”
Thermalin is continuing the non-clinical development studies that are necessary to advance T-1123 into clinical trials.
Thermalin is developing next-generation insulin solutions for people with T1D and T2D. Thermalin’s programs include (1) clinical candidate T-1123—a stabilized insulin analog that is ultra-rapid at both U-100 and U-500, (2) StampPump—a miniaturized glucose management system that will deliver the concentrated, ultra-rapid-acting formulation of T-1123, (3) basal and mix insulins that never need refrigeration, and (4) a glucose-responsive insulin that protects against hypoglycemia by losing potency when glucose levels are below normal. For more information, please visit www.thermalin.com. For background on insulin therapy for diabetes, please visit www.thermalin.com/background