MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today 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