MannKind Presents Positive Afrezza® Clinical Data from STAT and AFFINITY Studies at ADA 78th Scientific Sessions
Poster 1017-P: Afrezza provides improved Time-in-Range on Continuous Glucose Monitoring compared to insulin aspart
Poster 102-LB: Hypoglycemia is reduced with use of Afrezza compared to insulin aspart
STAT Study Poster Highlights:
|Title:||Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) compared to insulin Aspart in Patients with T1D—STAT Study|
|Highlights:||Compared to insulin aspart, the per-protocol use of Afrezza (i.e., with supplemental doses 1 and/or 2 hours post-meal):
|Conclusion:||The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia|
“We are very pleased to present results of the novel STAT trial. This is the first time we have seen a rapid-acting mealtime insulin provide a superior outcome when utilized with CGM in a treat-to-target dosing strategy. The results demonstrated that Afrezza dosed before and (as needed) after meals significantly improved all-day glucose time-in-range, limited daytime glucose variability and significantly reduced the overall rate and time spent in hypoglycemia,” stated
Affinity-1 Late Breaking Poster Highlights:
|Title:||Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes|
|Highlights:||Compared to insulin aspart:
|Conclusion:||Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events.|
“The late breaking poster presentation, from a post-hoc regression analysis of a representative subset of the AFFINITY 1 study patient, evaluated overall and severe hypoglycemia event rates with AFREZZA relative to insulin aspart in Type 1 diabetes patients. This analysis, which controlled for a number of variables that can impact glucose control and rates of hypoglycemia, demonstrated that use of Afrezza resulted in significantly lower rates of hypoglycemia in Type 1 diabetes patients across a wide range of HbA1c as compared to insulin aspart. Hypoglycemia remains one of the major factors that limit to the ability of healthcare providers and patients to intensify insulin therapy and can further limit the ability to achieve optimal glucose control,” continued Dr. Kendall.
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
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SVP, Investor Relations