MannKind Corporation Announces Positive 17-Week Results from the INHALE-3 Study

Published: 2024-06-22 08:00:00 ET MNKD

MannKind Corporation announced positive 17-week results from the INHALE-3 study, a Phase 4 U.S. clinical trial evaluating Afrezza® (plus basal insulin) vs. usual care (defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation) utilizing a higher initial conversion dose from mealtime injectable insulin to inhaled insulin. The study, which was presented by the INHALE-3 investigational team at the American Diabetes Association?s (ADA) 84th Scientific Sessions in Orlando, met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group.

Key sub-analysis findings included: More subjects utilizing inhaled insulin achieved glycemic targets: 30% of inhaled insulin group reached <7% (HbA1c) at 17 weeks vs. 17% of the usual care group; 21% of inhaled insulin group vs. 0% of usual care group met A1c goal of <7% if baseline was >7%; 24% of the Afrezza group and 13% of the usual care group achieved TIR above 70% with no increased hypoglycemia in the inhaled insulin group.

No difference in CGM-measured hypoglycemia between the groups; Study helps to establish a titrated basal-bolus ratio that is approximately 70/30 inhaled insulin to basal vs. 50/50 for usual care; While more people met the glycemic target of A1c (less than 7%) with Afrezza, some subjects worsened when switching from usual care to inhaled insulin, potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime; More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza. The INHALE-3 study is a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites.

The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks.

The full 30-week results of INHALE-3 will be presented at future conferences.