MannKind Presents Positive Original Analyses of Afrezza® Cli

[kite]

www.globenewswire.com/news-release/2020/06/15/2048129/0/en/MannKind-Presents-Positive-Original-Analyses-of-Afrezza-Clinical-Data-at-American-Diabetes-Association-ADA-80th-Scientific-Sessions.html

WESTLAKE VILLAGE, Calif., June 15, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) announced that new data from clinical studies of Afrezza® (insulin human) Inhalation Powder was presented at the American Diabetes Association’s 80th Scientific Sessions, June 12-16, 2020.



The data presented includes:



A comprehensive post hoc analysis of four unique studies assessing the safe and effective dosing of Afrezza in patients with type 1 diabetes1 (Poster 1023)

An analysis demonstrating treatment with Afrezza is associated with weight loss in patients with type 2 diabetes, compared to weight gain with injected mealtime insulin2 (Poster 1024)

An evaluation of a comprehensive two year safety study showing that significant changes in FEV1 (as a measure of pulmonary function) during treatment with Afrezza are both uncommon and generally transient in nature3 (Oral Abstract 235)

”We are pleased to present these clinical studies detailing the safe and effective use of Afrezza at this year’s virtual ADA Scientific Sessions,” stated David Kendall, MD, Chief Medical Officer MannKind. “These studies provide further support of the effectiveness and clinical safety of Afrezza therapy and offer important insights on effective dosing of Afrezza, the favorable effect of Afrezza on body weight, and the improvement in clinical outcomes possible when converting patients to Afrezza therapy.”



Highlights of the presentations are described below. See the appendix for presentation details.



Poster 1023: Dose Titration and Clinical Effects of Inhaled Technosphere® Insulin Compared with Mealtime Subcutaneous (SC) Analog Insulin Therapy in Type 1 Diabetes (T1D)



Ultra rapid-acting Afrezza can be safely and effectively dosed at 1.5 to 2.0 times that of injected mealtime insulin

This dosing ratio appears to be consistent across a range of A1C responses

Afrezza’s ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing and provides patients the ability to flexibly dose based on glycemic response

Poster 1024: Technosphere® Insulin Added to Basal Insulin Is Associated with Less Weight Gain than Basal Insulin plus Insulin Aspart or Insulin Analog (aspart) 70/30 Mixture in Type 2 DM



Patients with type 2 diabetes treated with Afrezza showed modest weight loss while those treated with insulin aspart or insulin aspart mix resulted in weight gain

The weight difference estimate between Afrezza and insulin aspart was 1.83 pounds

The weight difference estimate between Afrezza and biaspart insulin was 3.17 pounds

The effect on body weight was independent of the magnitude of improvement in glucose control

Oral Abstract 235: Incidence of Significant Changes in Pulmonary Function during A 2-year Study with Inhaled Technosphere® Insulin



Prior clinical studies have shown a modest (~40 ml) difference in mean change in FEV1 over two years when comparing treatment with Afrezza to other diabetes therapies

The majority (88%) of individuals treated with Afrezza had no significant change in FEV1 measured at any time

Overall, 98% of patients on Afrezza (vs. 99% of usual care) had either no significant change (≥15%) or were observed to have only a transient change in FEV1 over the two years of study

[novafett]

This the reason for the pop today?

[casualinvestor]

ADA 2020 and/or pumping. We'll find out in a few days

[goyocafe]

Can we have a Covid-19 booster to get this into orbit, please!

[rfogel]

I found "Afrezza’s ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing" rather confusing. How does afrezza's RA profile "supersede the perceived precision" of injected insulin?

[sayhey24]

Jun 15, 2020 14:34:39 GMT -5 rfogel said:

I found "Afrezza’s ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing" rather confusing. How does afrezza's RA profile "supersede the perceived precision" of injected insulin?

This has been a major topic on this board for years.  RAA users go through all kinds of gyrations doing carb counting to determine the "exact" amount of RAA to inject.  Then they inject and they have no idea how fast it will be absorbed.  From shot to shot this factor varies and and can vary pretty dramatically.  It also works too slow to signal the liver when injected.

With afrezza its very forgiving.  The absorption rate doesn't vary.  Take a puff and its going to peak in about 30 minutes. Because of its speed it signals the liver which stops making glucose.  If you take to much the liver is signaled to release glucose.  If you take to little, just take another puff.

So, while you are doing all these calculations and trying to be so precise with the RAA it is exactly to opposite because of absorption speed and liver interaction.  In the case of the RAA the perception of precision is not reality.  At the same time they will try and argue the small medium and large dosing of afrezza is too crude, its "not precise" enough when in fact afrezza works so much better at mimicking natural pancreatic release.

[rfogel]

Jun 15, 2020 15:25:42 GMT -5 sayhey24 said:

Jun 15, 2020 14:34:39 GMT -5 rfogel said:

I found "Afrezza’s ultra rapid-acting profile may supersede the perceived precision of injected mealtime insulin dosing" rather confusing. How does afrezza's RA profile "supersede the perceived precision" of injected insulin?

This has been a major topic on this board for years.  RAA users go through all kinds of gyrations doing carb counting to determine the "exact" amount of RAA to inject.  Then they inject and they have no idea how fast it will be absorbed.  From shot to shot this factor varies and and can vary pretty dramatically.  It also works too slow to signal the liver when injected.

With afrezza its very forgiving.  The absorption rate doesn't vary.  Take a puff and its going to peak in about 30 minutes. Because of its speed it signals the liver which stops making glucose.  If you take to much the liver is signaled to release glucose.  If you take to little, just take another puff.

So, while you are doing all these calculations and trying to be so precise with the RAA it is exactly to opposite because of absorption speed and liver interaction.  In the case of the RAA the perception of precision is not reality.  At the same time they will try and argue the small medium and large dosing of afrezza is too crude, its "not precise" enough when in fact afrezza works so much better at mimicking natural pancreatic release.

Thanks for the explanation.  They should have made that more clear in the PR. I have to wonder how many reading it understood what it was referring to.