Rezolute Announces Results from AB101 Trial Evaluating Diabetes Treatment

Rezolute announced top-line results from its Phase 1 trial of AB101, an ultra-long acting basal insulin for potential use in patients with type 1 and type 2 diabetes. AB101 was administered subcutaneously in three ascending dosing cohorts in patients with type 1 diabetes, which resulted in slow onset and sustained insulin levels and activity for more than seven days. However, at the higher doses, the necessary drug volume was greater than anticipated, as was variability in onset time between patients. Consequently, the Company believes that additional formulation development is required before advancing the program further in the clinic.

"Observing a slow, sustained release of insulin for over one week after a single administration of AB101 is noteworthy," said Nevan Elam, Chief Executive Officer of Rezolute. "While we will not invest further in the program, we hope to identify a pharmaceutical partner with the necessary resources and expertise to optimize AB101’s formulation and continue its clinical development."

This single ascending dose study, AB101-01, was designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB101, in subjects with type 1 diabetes who were on background continuous, subcutaneous insulin infusion. AB101 was generally safe and well tolerated, without dose-limiting side effects or occurrence of sudden insulin release. At the mid and high dose levels, AB101 demonstrated a dose-dependent insulin time-action profile that was sustained for more than seven days. Decreased background basal insulin requirements were observed generally, and increased glucose requirements were seen during periodic hyperinsulinemic-euglycemic clamp tests, which are used to evaluate insulin pharmacology. These effects correlated with the observed concentration-time profile of AB101.

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