NIH Awards Thermalin Inc. a Direct-to-Phase II SBIR Grant to Advance Development of Insulin Analog T-1123
Cleveland, Ohio, September 12, 2020 – Thermalin Inc. has been awarded a 2-year, $2.99M Direct-to-Phase II SBIR grant by the National Institutes of Health to advance development of its novel insulin analog, T‑1123. Studies submitted to support the award demonstrated (a) ultra-rapid absorption kinetics, comparable with those of U‑100 Fiasp®, for both U‑100 and U‑500 formulations of T‑1123 in swine euglycemic clamp studies, (b) glucose-lowering potency of T‑1123 in animal models that is comparable to human insulin and the prandial insulin analogs, (c) significantly enhanced chemical and physical stability of T‑1123, and (d) mitogenic potency of T‑1123 that is less than human insulin.
Dod Michael, Ph.D., Thermalin’s Chief Scientific Officer noted, “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 disposable patch pumps. This is of commercial interest because T‑1123’s markedly augmented stability would enable pre-filling of tubed pump and patch pump reservoirs at the time of manufacture. The U‑500 ultra-rapid-acting formulation enables our co-development of a miniaturized, pre-filled and disposable closed-loop diabetes management system the size of a postage stamp that we call the StampPump™.”
The work to be funded by this award will include (1) finalizing the formulation of T‑1123; (2) finalizing manufacturing scale-up conditions, transferring this technology to a contract manufacturing organization and producing an engineering lot of T‑1123 sufficient to support all IND-enabling toxicology studies; and (3) completing pre-clinical toxicology testing of the finalized T‑1123 U‑100 formulation. Attainment of these Phase II milestones would favorably position Thermalin Inc. to initiate SBIR Phase IIb- or investor-funded clinical safety/efficacy trials and to attract a corporate partner to further the development of T‑1123.
This research will be supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK126613. The content of this announcement is solely the responsibility of Thermalin Inc. and does not necessarily represent the official views of the National Institutes of Health.
Thermalin, a privately held biotechnology company with its main laboratories in Cleveland, Ohio, 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.