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MannKind Presents New Scientific Data at 54th Annual Meeting of the European Association for the Study of Diabetes

Posted on October 03, 2018 by Medtech[y] Staff


MannKind Corporation (Nasdaq:MNKD), announced that it presented new scientific data in an oral and poster presentation at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany. The oral presentation (presentation 55) and poster presentation (poster 1046; PS 097) both took place Tuesday, October 2, 2018. MannKind’s STAT study results were also presented at the conference in two poster presentations (Poster 813; PS 068 and Poster 677; PS 051).

  • Presentation 55 Total and severe hypoglycemia is reduced with use of inhaled Technosphere® Insulin (TI) relative to insulin aspart in type 1 diabetes
  • Poster 1046; PS 097 Diabetes duration, BMI, and HbA1c have greater effects on Pulmonary Function (PF) than inhaled Technosphere Insulin (TI) 

Oral Presentation Highlights

Title: Total and Severe Hypoglycemia is Reduced with Use of Inhaled Technosphere Insulin (TI) Relative to Insulin Aspart in Type 1 Diabetes

Presenter: David Kendall, MD, Chief Medical Officer, MannKind Corporation

Description: A post-hoc regression analysis of a representative subset of the AFFINITY 1 (24-week treat-to-target in type 1 diabetics) evaluated overall and severe hypoglycemic event rates in patients with Afrezza relative to subcutaneous insulin.

Highlights:

  • Individuals on Afrezza experienced significantly lower rates of hypoglycemia vs insulin aspart
  • Overall rates of hypoglycemia with Afrezza were 26% lower across all levels of HbA1c
  • Differences in the average achieved HbA1c do not account for the observed differences in hypoglycemia rate
  • Afrezza allows for greater HbA1c reduction with lower rates of hypoglycemia
  • HbA1c could be reduced from 8.0% to approximately 6.8% and meet treatment goal with no increase in hypoglycemia rate;
  • Patients already at 6.8% HbA1c would be expected to experience 4 fewer hypoglycemia events per month.

Conclusion: The ultra-rapid time action profile of Afrezza provides tight glycemic control without increasing the risk of hypoglycemia. Switching to Afrezza as mealtime insulin therapy may also benefit the patients already at HbA1c goal by reducing the frequency of hypoglycemic
events.

Poster Presentation Highlights

Title: Diabetes Duration, BMI, and HbA1c Have Greater Effects on Pulmonary Function (PF) Than Inhaled Technosphere Insulin

Presenter: Frank Pompilio, PharmD, VP, Medical Affairs, MannKind Corporation

Description: Data from a pulmonary function study of patients with type 1 and type 2 diabetes was utilized to evaluate the effects of diabetes duration, body mass index, and HbA1c on baseline PF and changes in PF during 24 months of treatment when compared in patients receiving Afrezza and usual care.

Highlights

  • The magnitude of Afrezza’s effect on FEV 1 was comparable to those normally associated with diabetes-related factors such as high body mass index (BMI), elevated HbA1c and long-standing diabetes
  • None of these effects were clinically significant
  • Afrezza-related decreases in FEV1 were small, non-progressive and reversible after two years of treatment

Conclusion: Diabetes-related factors are associated with reductions in pulmonary function that exceed the reversible changes seen with inhaled insulin treatment. The effects of Afrezza on pulmonary function are not clinically significant, do not increase with time, and have been demonstrated to resolve if treatment with Afrezza is stopped.

“These two presentations represent just two of the numerous disclosures we hope to publish in the coming months,” said David Kendall, M.D., Chief Medical Officer of MannKind Corporation. “These two studies are critical to helping build awareness of the potential clinical impact and longer term safety of Afrezza. These and other recently published data significantly advance our understanding of the treatment opportunity that Afrezza therapy may offer. MannKind’s medical, regulatory and safety teams are committed to ensuring that this information is made available to both individuals living with diabetes and the medical community alike, and we are pleased that we were able to share this data more broadly at EASD.”

MannKind at Cantor Fitzgerald Global Healthcare Conference