Gestational Diabetes - Afrezza "Growth Opportunity"

[hellodolly]

Thinking recently on the quarterly slide presentation and the addition of 'gestational diabetes' as a growth opportunity I decided to start a thread on the topic so we have a dedicated place to discuss this moving forward.  The MNKD slide indicates that there are over 250,000 new cases of GD diagnosed each year. 

Digging further, I found the following market research on the topic: "Gestational Diabetes Market Size was valued at USD 8.63 Billion in 2023. The Global Gestational Diabetes industry is projected to grow from USD 9.27 Billion in 2024 to USD 16.54 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 8.10% during the forecast period (2024 - 2032).
Source: www.marketresearchfuture.com/reports/gestational-diabetes-market-4591

NIH has a publication, dated Aug 2023, with the most recent discussion on GD.  
Source: www.ncbi.nlm.nih.gov/books/NBK545196/

I have no idea where Mike is thinking of taking this in terms of development and testing but, my hunch is this could be important enough to get funding from outside sources like ADA, NIH, or a combination of this along with in-kind contributions by MNKD since we're talking about the impacts on mothers and babies.  I don't necessarily see BP wanting to get involved and as far as UTHR, not in their wheelhouse.  Either way, this is going to be of interest to shareholders going forward and makes the world of sense.   

[letitride]

Trial info
clinicaltrials.gov/study/NCT06535789?term=mannkind&rank=51

[Clement]

^ "They [trial participants] will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal."

Study Start (Estimated)
2024-09
Primary Completion (Estimated)
2024-12
Study Completion (Estimated)
2024-12
Enrollment (Estimated)
30
Study Type
Interventional
Phase
Phase 2
Phase 3

All this info tells me that this trial is short and it's Phase 2 and 3.

[hellodolly]

Aug 15, 2024 4:08:07 GMT -5 letitride said:

Trial info
clinicaltrials.gov/study/NCT06535789?term=mannkind&rank=51

Thanks. So, this study was first submitted about two weeks ago.  Did I miss any announcements?  

[sayhey24]

Aug 15, 2024 6:03:24 GMT -5 hellodolly said:

Aug 15, 2024 4:08:07 GMT -5 letitride said:

Trial info
clinicaltrials.gov/study/NCT06535789?term=mannkind&rank=51

Thanks. So, this study was first submitted about two weeks ago.  Did I miss any announcements?  

No you did not miss it.  This is not an "official" MNKD trial.  MNKD is a collaborator.
sponsor - Jaeb Center for Health Research

[prcgorman2]

I would be a little surprised if the FDA approved use of Afrezza for treatment of gestational diabetes from this trial. I expect the trial to be more of an investigation into whether a larger trial should be initiated to verify SAFETY as much as anything else. A young friend of mine would have been a candidate for this trial a few years ago. They gave her a prescription for a CGM and prescribed metformin. From what I understood, the CGM was merely for tracking purposes (i.e., how much harm is being done) to decide whether to modify the treatment. Ugh. The market size is good, but I have to believe the “young mother” testimonial advertising of ease and benefit of Afrezza will be very influential.

[letitride]

It would be nice if more trials were done on someone else's dime. And is Afrezza considered pediatric and if so does Inhale 1 cover that? I saw no black box warnings for pregnancy.

[agedhippie]

Afrezza can be prescribed for use during pregnancy today, the label doesn't forbid it. This trial is about quantifying the impact with a meal. I would expect a far bigger trial if they wanted to seriously get traction in GDM because insulin requirements vary wildly during pregnancy. Initially you require less insulin, and later you require twice as much insulin. For that reason I would expect a trial to last most of the term to prove that it can be adequately titrated throughout.

I am interested in this in the existing diabetic case. Your endo will want your A1c at or below 6.5 before you become pregnant, and then to keep below 140 for the whole term. This is not easy, but it can be done (I know a few people who have managed it). I feel that Afrezza would be ideal because it hits that post meal spike, and while normally you don't really care about it in pregnancy it matters. This is why Carol Levy is so interested in it - she deals with a lot of women who are or want to be pregnant.

The GDM market is large, but only 15% of women with GDM need insulin.

[casualinvestor]

I really like Afrezza for the GDM space. Mostly because it has a much higher level of management from the physician. As far as size, just getting 5% of the 15% of the 250,000 cases per year is still 2500 patients for 3-5 months of the year. Also, if safety superiority with Afrezza can be established then the % of GDMs given Afrezza will get much higher.

Are GD patients given a CGM?

[prcgorman2]

Aug 15, 2024 11:12:38 GMT -5 casualinvestor said:

I really like Afrezza for the GDM space. Mostly because it has a much higher level of management from the physician. As far as size, just getting 5% of the 15% of the 250,000 cases per year is still 2500 patients for 3-5 months of the year. Also, if safety superiority with Afrezza can be established then the % of GDMs given Afrezza will get much higher.

Are GD patients given a CGM?

I have a young friend who was given a prescription for metformin and a CGM.

[agedhippie]

Aug 15, 2024 11:12:38 GMT -5 casualinvestor said:

I really like Afrezza for the GDM space. Mostly because it has a much higher level of management from the physician. As far as size, just getting 5% of the 15% of the 250,000 cases per year is still 2500 patients for 3-5 months of the year. Also, if safety superiority with Afrezza can be established then the % of GDMs given Afrezza will get much higher.

Are GD patients given a CGM?

Yes, because they need to see if they can cope without insulin and that could change at any time.

[sayhey24]

Aug 15, 2024 16:13:04 GMT -5 agedhippie said:

Aug 15, 2024 11:12:38 GMT -5 casualinvestor said:

I really like Afrezza for the GDM space. Mostly because it has a much higher level of management from the physician. As far as size, just getting 5% of the 15% of the 250,000 cases per year is still 2500 patients for 3-5 months of the year. Also, if safety superiority with Afrezza can be established then the % of GDMs given Afrezza will get much higher.

Are GD patients given a CGM?

Yes, because they need to see if they can cope without insulin and that could change at any time.

Thats the beauty of afrezza.  If they are borderline give them the afrezza.  It will reduce the BG to near normal levels and they won't get the hypo.

With afrezza all this worrying and wondering about coping is a thing of the past.

[agedhippie]

Aug 15, 2024 21:04:16 GMT -5 sayhey24 said:

Aug 15, 2024 16:13:04 GMT -5 agedhippie said:

Yes, because they need to see if they can cope without insulin and that could change at any time.

Thats the beauty of afrezza.  If they are borderline give them the afrezza.  It will reduce the BG to near normal levels and they won't get the hypo.

With afrezza all this worrying and wondering about coping is a thing of the past.

I think misunderstand what I meant by cope. If they can cope without insulin (and 85% can) then they will not be given it because it's unnecessary. Worry and cope in the sense I think you meant it is different. Oh, and Afrezza can give hypos - the trial data shows that.

[sayhey24]

Aug 15, 2024 22:28:49 GMT -5 agedhippie said:

Aug 15, 2024 21:04:16 GMT -5 sayhey24 said:

Thats the beauty of afrezza.  If they are borderline give them the afrezza.  It will reduce the BG to near normal levels and they won't get the hypo.

With afrezza all this worrying and wondering about coping is a thing of the past.

I think misunderstand what I meant by cope. If they can cope without insulin (and 85% can) then they will not be given it because it's unnecessary. Worry and cope in the sense I think you meant it is different. Oh, and Afrezza can give hypos - the trial data shows that.

With afrezza, coping without insulin is old school thinking.  The goal is to stop the meal time spike not looking at a 3 month A1c.  If the to be mom is going over 140 and staying there over 2 hrs get her the afrezza.  There is no need to cope anymore.  Get her down and to baseline.

Now if the to be mom is not taking another med which will interfere, the liver will prevent the hypo.  In most cases its not an issue.  I think VDex has a paper with some nice CGM reports of taking afrezza without eating.

[agedhippie]

Aug 16, 2024 9:56:57 GMT -5 sayhey24 said:

With afrezza, coping without insulin is old school thinking.  The goal is to stop the meal time spike not looking at a 3 month A1c.  If the to be mom is going over 140 and staying there over 2 hrs get her the afrezza.  There is no need to cope anymore.  Get her down and to baseline.

Now if the to be mom is not taking another med which will interfere, the liver will prevent the hypo.  In most cases its not an issue.  I think VDex has a paper with some nice CGM reports of taking afrezza without eating.

If the patient is reliably over 140 2 hr after meals then they will be put on insulin today - end of story. If they are not (again, as 85% are not) then they will not be put on insulin. This is really simple.

To be honest, I am not really replying to you in what follows, but rather to point out to anyone stumbling across this thread by accident that all insulin can cause hypos and that includes Afrezza. The idea that Afrezza does not cause hypos is laughable. I don't know about Vdex, but in their own clinical trial Mannkind had the Type 1 arm shutdown because of the number of hypos.  Read the data here: clinicaltrials.gov/study/NCT00747006

I wait to see your trial data showing Afrezza cannot cause hypos