MannKind Stock Gets Lift From Multiple Afrezza Studies Presented

Posted on February 20, 2020 by Medtech[y] Staff

MannKind (NASDAQ:MNKD) stock is up ~3% after announcing the presentation of results from multiple clinical studies of Afrezza and MannKind’s BluHale technology system.

These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020.

“We are very pleased to have the opportunity to highlight these positive results during this year’s ATTD,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes, and include initial studies of Afrezza in pediatric patients. In addition to the results of clinical studies, we are pleased to disclose novel data on the use of BluHale, our Bluetooth-enabled technology for real-time profiling of inhalation effort and other parameters associated with the use of our inhaler. Collectively, these data further expand our understanding of the unique clinical profile of Afrezza, and highlight the potential use of Afrezza in children and adolescents, as well as advancing the opportunity to create connected technology for our drug delivery system.”

Highlights of the original scientific disclosures:

  • Preliminary data from an independent, investigator initiated study of Afrezza on the background of closed loop pump insulin delivery by means of an “artificial pancreas” system showed that pulmonary dosing allows for titration to higher unit doses in individuals with type 1 diabetes (presented by

    Alfonso Galderisi MD, PhD from Yale University).

  • Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr.

    Philip Levin MD, Endocrinology, MODEL Clinical Research).

  • Pharmacokinetics (and pharmacodynamics) of Technosphere insulin in children and adolescents ages 8-17 with type 1 diabetes showed that the ultra rapid rise in insulin concentrations corresponded with early post-prandial glucose control within the first hour post-dose, similar to what has been observed in adult patients.
  • Two poster presentations highlighting the use of MannKind’s unique Bluetooth enabled technology for enhanced instruction on use of the Afrezza inhaler and as a tool to provide connected dose information on top of continuous glucose monitoring data.

Dr.Phillip Levin, Principal Investigator from MODEL Clinical Research in Baltimore, MD and lead author on the study of uncontrolled type 2 diabetes patients, noted that “the addition and rapid titration of Afrezza in patients with type 2 diabetes not currently at goal using two or more glucose lowering therapies, resulted in a 1.6% reduction in A1C and significantly increased time in range as measured by CGM. Our study provides additional clarity on both dose requirements and the clinical impact of adding ultra rapid-acting Afrezza therapy in uncontrolled type 2 diabetes.”

In addition to the original scientific disclosure presented at this year’s ATTD meeting, Dr. Kendall will participate as faculty in the “Ultra-rapid Insulin Analogues” session on Saturday, February 22, during which he will provide a current perspective on the clinical use of Afrezza, including evidence that ultra rapid-acting Afrezza can be safely and effectively titrated in fixed dose increments and that speed of insulin action may supersede dose precision for achieving post-prandial glucose control.