MNKD presentation at ADA on inhale 3 results

[rebby]

Jun 23, 2024 9:02:44 GMT -5 agedhippie said:

Jun 23, 2024 6:20:17 GMT -5 lennymnkd said:

Do these results now get presented to
The FDA for possible label changes …..
Black box , possible superiority.. 🤞

I think a label change is possible down the road as a result of this trial. There was a comment by Dr Hirsch, "The bottom line is we need to understand appropriate dosing for both the inhaled and the basal insulin." You can see why when the bolus to basal ratio is 70:30 rather than 50:50 as those numbers imply that Afrezza is half the strength it claims. Fixing that will stop less experienced endos from under-dosing and wondering why Afrezza doesn't work.

So;
    - I think there will be label changes, but not yet as I suspect they will need more specific trials for that.
    - Black box will not change as that has nothing to do with Afrezza's effectiveness and is a DPI matter.
    - Interestingly a lot of the secondary outcomes were collected to show superiority at the 17 week mark but no claims were made over that.

For me the main thing was a large number of endos hearing a panel of KOLs say they liked Afrezza and it was useful. This should help dispel some of the FUD that has accumulated over the years. There was a particularly interesting comment in the ADA symposium PR;

Moving forward, Dr. Blevins said it will be important to further define guidelines and best practices for the use of inhaled insulin. However, it will ultimately be up to patients and their providers to determine whether the therapy is right for them.

That could lead to a consensus on how to use inhaled insulin and potentially inclusion in the SoC. Not soon, but in the future.

Fantastic insight…great potential moving forward but a bit disappointing this where we are (still understanding proper dosing) after a decade.

[celo]

I hate this word with Afrezza and especially MNKD stock, but I think in this instance a little PATIENCE will pay off. I think Dr. Aleppo points out a lot of the history of fear Endocrinologist have had when prescribing Afrezza.
First few years after it was approved in 2014 was the is it safe time?
Then the next few, was the time of how does Afrezza actually work.
The last few I feel Doctors know it works but are still hesitant. Even this study pointed out patients needed 2.5-3 ratio for Afrezza over rapid acting injectable. Not the 2-1 ratio, I think has been the mainstay.
Patients in the study stopped using Afrezza due to the amount of insulin they believed they were taking was too much. That was the main reason for only a 50% continuation after the 17 weeks. But as Dr. Aleppo points out patients need to see through the ratio and do what's right for them. Every patient is different. Dr. Aleppo used one patient as an example. They were scared with Afrezza they were using too much insulin. But this patient had their diabetes completely under control by using a highly restrictive low carb diet.

www.hcplive.com/view/diabetes-dialogue-inhale-3-and-diabetes-tech-updates-with-grazia-aleppo-md

I highlighted The quote below to show the individuality of diabetes management. Endocrinologist wanting to utilize afrezza will really need to know their patients. It's not easy. But at least this study will allow them to distinguish better the ones that may benefit. I believe this will take some time and patients for Mannkind to see the increase in Afrezza uptake.

"The panel of INHALE 3 investigators suggested that poor candidates might include those patients with a fear of hypoglycemia that keeps them from dosing at bedtime, or who have a lot of auto boluses given by their automated infusion pump suggesting that they're not proactive about management."

www.medpagetoday.com/meetingcoverage/ada/110781

[agedhippie]

Jun 23, 2024 13:10:46 GMT -5 celo said:

...
The last few I feel Doctors know it works but are still hesitant. Even this study pointed out patients needed 2.5-3 ratio for Afrezza over rapid acting injectable. Not the 2-1 ratio, I think has been the mainstay.
...
"The panel of INHALE 3 investigators suggested that poor candidates might include those patients with a fear of hypoglycemia that keeps them from dosing at bedtime, or who have a lot of auto boluses given by their automated infusion pump suggesting that they're not proactive about management."

www.medpagetoday.com/meetingcoverage/ada/110781

The official to actual ratio for units needs to be fixed, but I am not sure that is possible at this time. If 1u of Afrezza was normalized to 1u of RAA the apparent cost of Afrezza would look terrible (2.5x the current price).

The link to medpagetoday is good. It is a report of the symposium and not just a regurgitation of the ADA release. I dislike the line about not being pro-active in their management as it lack context for why they are relying on the AID pump to do the work - a topic on which I have ranted extensively.

[celo]

Best article summarizing the results and pitfalls for individuals that had difficulties with Afrezza. Proactive diabetics had the best outcomes.

www.medscape.com/viewarticle/inhaled-insulin-plus-degludec-option-type-1-diabetes-2024a1000bmb

[celo]

It's interesting if Afrezza will have great uptake by children. I believe if children started out on Afrezza with a once a day shot and that is all they knew, children would love it..
But to have to stay on top of the Afrezza timing issues may be difficult, especially after being used to pump or injection regemint.
That being said, no kid likes to stab themselves all the time. No kid likes to strap a pump on while being an active kid. I saw a teenage girl at a volleyball tournament in a bathing suit with a pump on one arm and a Dexcom patch on the other. She was hanging out with friends and having a great time but if the pump could be removed, I'm sure an active teenage girl would be all for it.

[sayhey24]

Jun 23, 2024 9:20:33 GMT -5 agedhippie said:

Jun 23, 2024 5:53:21 GMT -5 sayhey24 said:

So Aged, what do you think?  It seems with the CGM Inhale 3 did better than the one testing site during the 171 when the FDA accused the good doctor of cheating.
...

I think you have told us T1s don't like to switch a routine which was working.  More than 50% of subjects at the end of the study expressed an interest in continuing to use Afrezza®  Now thats pretty shocking.
...

Ten years down the line I would definitely expect we could do better that the 171 trial. As for the rest; show me the data and not a headline.

You have a trial population who are not conservative about their routine or they wouldn't be in a clinical trial. That 50% number is not surprising at the end of the trial, but what it doesn't do is breakdown the strength of feeling or the role they see for Afrezza in their future. Is it - yes we will definitely swap, or possibly we will keep some around as a rescue inhaler? Again, data please.

Damn - ten years down the line and I was finally hoping you would say - GD Forest, you were right.  Nope - just as expected, the trial was not good enough.

IMO - the study is good enough to move the needle on the SoC and we had the '69 Mets presenting.  Do you really think that group of presenters would have gotten involved if the results were not GD Outstanding?  No way - Say Hey!

Next Step - SoC updates and we need to get the best lobbyists for the best results.  After the Inhale 2 and the Inhale 1 we go for label change.  Now Mike needs to focus on T2s and GLP1s.

[sayhey24]

Jun 23, 2024 15:57:50 GMT -5 celo said:

It's interesting if Afrezza will have great uptake by children. I believe if children started out on Afrezza with a once a day shot and that is all they knew, children would love it..
But to have to stay on top of the Afrezza timing issues may be difficult, especially after being used to pump or injection regemint.
That being said, no kid likes to stab themselves all the time. No kid likes to strap a pump on while being an active kid. I saw a teenage girl at a volleyball tournament in a bathing suit with a pump on one arm and a Dexcom patch on the other. She was hanging out with friends and having a great time but if the pump could be removed, I'm sure an active teenage girl would be all for it.

Inhale 3 showed a 50% switch rate for T1 adults.  Traditionally, few T1 adults who have something which works are willing to switch.  The AID was an easy transition from the pump which most had since they were kids.

For kids, switching is easy.  They all hate pumps.  Any kid trying to play a sport really hates the pump.  The CGM is not so bad but a pump really sucks.  Afrezza has now proven what Sports and Bill and I have been saying for years.  I would expect at least a 50% if not better adoption rate with the kids which means over time afrezza will own 50% of the T1 market.

With the CGM and the "Mom"  having to stay on top of the Afrezza timing issues is a no brainer.  Before the CGM and the Mom's iPhone, not so easy.  Now, a no-brainer.

[ronw77077]

Wonderful video/commentary on the Inhale 3 results from Diabetes Dialogue: INHALE-3 and Diabetes Tech Updates, with Grazia Aleppo, MD

She is Grazia Aleppo, MD, professor of Medicine and director of the Diabetes Center at Northwestern University,

www.hcplive.com/view/diabetes-dialogue-inhale-3-and-diabetes-tech-updates-with-grazia-aleppo-md

[prcgorman2]

I used to get medscape.com articles so I’m pleased to see they covered the MannKind ADA Symposium. I have respect for that journal. Not saying they’re the NEJM, but they seemed competent (to me).

Really great comments in this thread. Would have loved to have seen this study and these results about 6 years ago when I assume Sanofi would have been able to produce them (if not sooner). Its no wonder MannKind was in such dire straits in 2015. Night and day and I’m thanking the Board and management. Onward and upward!

[radgray68]

Can’t help but thinking about my favorite speculation stock. Please bear with me, I’m 4 shots of Maker’s in this fine night.

This is just part of a multi pronged approach to the application for label changes needed for a full scale relaunch of Afrezza. That isn’t happening without the pediatric approval to open the market. It’s more expensive a drug to market because of the need for intensive onboarding with nurses and she-things but with CGM’s showing benefits in real time and about half the hypoglycemic episodes, it’s got a right to be a contender for SOC. All in my personal opinion, of course, I’ve imbibed this weekend with a cheers to closing above $5 since seemingly forever.

But, mark my words now. Because of all these small and now large enough preliminary studies like this one, pediatric approval and the ultimate relaunch of Afrezza will finally be possible. I celebrate this step
forward. See you at $10. ☺️

[uvula]

What are she-things? Pictures might be helpful.

[letitride]

Jun 23, 2024 9:05:48 GMT -5 agedhippie said:

Jun 23, 2024 8:08:29 GMT -5 letitride said:

I liked the way the ADA PR was written better than Mannkinds either way the results are awesome and Im extremely hopeful the 13 week extension is only going to get better. Lets Go!

I really want to see the data from this trial. I suspect that Dr Hirsch will publish his paper in the Diabetes Care so I am eagerly waiting for that.

 May be waiting for trial completion in October for full data set.

[letitride]

It seems to me when it comes to dosing outside the route of administration no one is talking about the elephant in the room. Physiology and Bio chemistry Afrezza is a monomeric human insulin. They are trying to copy and paste this to a hexameric dose. Maybe they should start by multiplying by 6.

[sayhey24]

Since the Adcom voted no on icodec because of hypos I think with the Inhale 3 results showing reduced hypos it would be in Novo Nordisk's best interest to run a trial with afrezza and see if the icodec/afrezza combo solves their hypo problem.

If icodec was available for the kids they would only need a single weekly shot and then afrezza during the day. I think that would be a huge win for the kids.

[hellodolly]

Study investigator Grazia Aleppo, MD, professor of Medicine and director of the Diabetes Center at Northwestern University, was once an Afrezza skeptic. In the video, she is now clearly convinced that Afrezza should be included in the treatment plan for PWD, especially those who have a hard time managing their disease. In fact, as she saw the results being produced during the trials, she started her own patients on Afrezza. 8:30 - 09:30 (time stamp)

Seems she was impressed with the meal time dosing and the ability to dose again (post meal) without the worry of hypo events due to the rapid acting nature of Afrezza. She also mentions safety several times in the interview.

www.hcplive.com/view/diabetes-dialogue-inhale-3-and-diabetes-tech-updates-with-grazia-aleppo-md