Objective
This grant seeks to move T-1123, a promising Ultra-rapid insulin, from pre-clinical studies to Phase I clinical trials. This critical first-in-human data will support T-1123's development as a best-in-class pump insulin to help Type 1 Diabetics get closer to "closing the loop" with automated insulin delivery.
Background Rationale
T-1123 is a preclinically validated ultra-stable insulin analog enabling concentrated, ultra rapid-acting formulations demonstrating superior stability and efficacy in comparison to currently available rapid-acting insulins. T-1123 is faster on than commercially available short acting insulins and remains stable at ambient and physiological temperatures, addressing a key unmet needs for rapid-acting insulin formulations that can be used in automated insulin delivery (AID) systems, particularly for managing mealtime glucose excursions. Current commercially available insulin formulations lack the stability and speed of action required for fully automated mealtime insulin delivery. T-1123’s stabWe believe this study will validate our preclinical evidence that T-1123 is a safe, best-in-class ultra-rapid insulin that could be integrated in pumps.ility profile and rapid onset make it an ideal candidate for integration into AID systems without the need for user input, thus alleviating the burden of manual meal boluses.
Description of Project
T-1123 is a preclinically validated ultra-stable insulin analog enabling concentrated, ultra rapid-acting formulations demonstrating superior stability and efficacy in comparison to currently available rapid-acting insulins. T-1123 remains stable at ambient and physiological temperatures, addressing a key unmet need for rapid-acting insulin formulations that can be used in automated insulin delivery (AID) systems, particularly for managing mealtime glucose excursions. Current commercially available insulin formulations lack the stability and speed of action required for fully automated mealtime insulin delivery. T-1123’s stability profile and rapid onset make it an ideal candidate for integration into AID systems without the need for user input, thus alleviating the burden of manual meal boluses.
We are seeking funding for a first-in-human Phase I study of T-1123, following GMP manufacturing and IND-enabling toxicology, to support Invictus Therapeutics’ efforts to develop and eventually commercialize T-1123.
Anticipated Outcome
We believe this study will validate our preclinical evidence that T-1123 is a safe, best-in-class ultra-rapid insulin that could be integrated in pumps and allow it move to larger in-patient trials.
Relevance to T1D
As mentioned in this RFA, while automated insulin delivery devices are used by a large and growing percentage of T1 diabetics, there are still limits to "closing the loop" including the need for meal announcements. We believe T-1123's best-in-class onset of action will help move closer to a true "closed loop" and improve the lives of T1 diabetics managing their insulin around mealtimes.