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Post by bthomas55ep on Sept 30, 2024 5:41:22 GMT -5
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Post by kite on Sept 30, 2024 6:10:16 GMT -5
More Adults With Type 1 Diabetes Achieved A1C Goal (<7%) After Switching From Multiple Daily Insulin Injections or Automated Pumps to Inhaled Insulin (Afrezza®)- 30-week results from the Phase 4 INHALE-3 study expand upon the positive 17-week data presented earlier this year at the American Diabetes Association’s 84th Scientific Sessions
- Switching to, or remaining on Afrezza allowed twice as many people to get to goal during the extension phase
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. The completer analysis which included all people on inhaled insulin, evaluated two separate groups – one that utilized Afrezza® (plus basal insulin) over 30 weeks, and a second group of patients who switched to Afrezza at week 17 from usual care, defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation. “The data from the extension phase of this study showed that more people living with T1D are able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care – whether they are using multiple daily injections or pumps,” said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. “We believe this data demonstrates to healthcare practitioners that Afrezza is an effective tool for their patients who want to improve their glycemic control.” Key Findings: - There was continued improvement in the Afrezza (plus degludec)-treated group, with additional subjects achieving A1c <7% at 30 weeks – a 100% increase from baseline:
- Switching from usual care to Afrezza (plus degludec) at week-17 allowed more than double the subjects to achieve A1c <7% at week-30, compared to the number at goal at week-17:
“With the positive data received at both 17- and 30-weeks, we continue to affirm that Afrezza is an important option for adult patients managing their diabetes,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. “We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025.”
About the INHALE-3 Study
The INHALE-3 study is a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control.
The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results previously shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks.
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Post by sayhey24 on Sept 30, 2024 6:58:23 GMT -5
Let me help Kevin out with a little addition
“With the positive data received at both 17- and 30-weeks, we continue to affirm that Afrezza is an important option for adult patients managing their diabetes and should be considered the new Standard of Care,” said Sayhey24
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Post by prcgorman2 on Sept 30, 2024 7:27:16 GMT -5
I am curious if agedhippie believes Kevin should have claimed the 30-week results are sufficient to change the Standard of Care (to be Afrezza in a primary position of treatment where mealtime insulin is needed)? I am pleased that the INHALE-3 results were technically reported in the 3rd quarter ahead of schedule. We’ll soon see if this news “moves the needle”. |
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Post by agedhippie on Sept 30, 2024 8:09:58 GMT -5
I am curious if agedhippie believes Kevin should have claimed the 30-week results are sufficient to change the Standard of Care (to be Afrezza in a primary position of treatment where mealtime insulin is needed)? I am pleased that the INHALE-3 results were technically reported in the 3rd quarter ahead of schedule. We’ll soon see if this news “moves the needle”. There is no way this changes the SoC. The issue is that the comparison this Afrezza vs everything else ("multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation"). What the endos care about is just the AID pumps - if you are on MDI today they are trying to move you off it, and non-AID pumps are effectively obsolete (they cost the same as an AID pump and have worse performance. Right now they are aging these pumps out). What is needed is a breakdown of the data between Afrezza and each of the classes; MDI, AID pumps, and dumb pumps because as it stand we don't know where the improvement came from. Was it across the board, was it just MDI? That is the data that endos will want to see. I found it interesting that although they collected TIR data it is not mentioned in the PR at all. Again, the important thing about this trial is raising awareness and overcoming prejudice against Afrezza. The trial shows that Afrezza performs and sets it in a context that validates that. This is going to start to put Afrezza into the list of things an endo will consider for treatment. The dosing data will be very useful for the label change and ensuring that new prescribers do not under-dose. |
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Post by uvula on Sept 30, 2024 8:19:27 GMT -5
The breakdown of data that aged wants (AID vs Afrezza) must already exist. Can we jump to the conclusion that if Afrezza gave better results, mnkd would have mentioned this?
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Post by daisyz on Sept 30, 2024 9:44:34 GMT -5
The study proves that a Type-1 can have a better A1C without being tethered to a pump. The study assumes/implies a better Time In Range. The study does not mention a Higher Quality of Life, but IMHO, is implied and as an eight year user of Afrezza with average A1Cs of 5.7 to 5.9, the Higher Quality of Life is everything and is a fact. There should be mention of how many study participants want to stay on Afrezza as their Standard of Care.
The results are a GRAND SLAM that we knew they would be.
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Post by sayhey24 on Sept 30, 2024 10:08:55 GMT -5
The breakdown of data that aged wants (AID vs Afrezza) must already exist. Can we jump to the conclusion that if Afrezza gave better results, mnkd would have mentioned this? No - they are bundling the results with the kids data and as they say “We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025.” I don't know what gestational data will be available by March but those results will be a slam dunk. The goal is SoC changes which will then bring insurance. |
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Post by prcgorman2 on Sept 30, 2024 11:19:13 GMT -5
The breakdown of data that aged wants (AID vs Afrezza) must already exist. Can we jump to the conclusion that if Afrezza gave better results, mnkd would have mentioned this? No - they are bundling the results with the kids data and as they say “We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025.” I don't know what gestational data will be available by March but those results will be a slam dunk. The goal is SoC changes which will then bring insurance. I recall label changes (governed by the FDA) were a goal. I don't recall anyone at MannKind saying (recently) that getting changes to the SoC is a goal of the INHALE-1, INHALE-3, and gestational diabetes trials.
I gave ChatGPT the following input:
"The American Diabetes Association (ADA) publishes a diabetes Standard of Care (SoC). Who and what is required to make changes to the ADA SoC?"
Here was the output:
"Changes to the American Diabetes Association (ADA) Standards of Care (SoC) are made through a rigorous process involving input from a panel of experts in the field of diabetes care, including researchers, clinicians, and medical professionals. The ADA convenes an Expert Committee that reviews the latest scientific evidence and research on diabetes treatment and management. Any proposed changes undergo extensive peer review, ensuring they align with current clinical practices and research findings. The recommendations are then approved by the ADA's Professional Practice Committee (PPC) before being incorporated into the SoC."
I'm not saying a change to the ADA SoC prioritizing Afrezza shouldn't be a goal, but I don't think that's been publicly stated by MannKind management although perhaps Dr. David Kendall said words to that effect before he left MannKind a few years ago. I would really like to know if changing the SoC is indeed a goal. If you can provide a reference where it is stated changing the SoC is a goal of the current trials, that would be really great.
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Post by cretin11 on Sept 30, 2024 11:38:30 GMT -5
Agree with sayhey that the goal is to have Afrezza included in the Standard of Care. This seems obvious, how could it not be the goal. Do we believe in Afrezza or not? I should think we do (VDEX sure does), and if not then there's a problem at MNKD.
These results looks good. It's a base hit at least. A grand slam? If we get the desired changes to SoC then that's a grand slam. All this is just my opinion, some may disagree or have less confidence in Afrezza.
prc suggests that MNKD management has never stated (publicly at least) that a change to SoC should be a goal. I hope prc is incorrect about that but i don't know without researching it. Would seem quite strange to me if the company does not want to change the SoC for the betterment of Afrezza and PWDs.
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Post by prcgorman2 on Sept 30, 2024 11:44:18 GMT -5
Agree with sayhey that the goal is to have Afrezza included in the Standard of Care. This seems obvious, how could it not be the goal. Do we believe in Afrezza or not? I should think we do (VDEX sure does), and if not then there's a problem at MNKD. These results looks good. It's a base hit at least. A grand slam? If we get the desired changes to SoC then that's a grand slam. All this is just my opinion, some may disagree or have less confidence in Afrezza. prc suggests that MNKD management has never stated (publicly at least) that a change to SoC should be a goal. I hope prc is incorrect about that but i don't know without researching it. Would seem quite strange to me if the company does not want to change the SoC for the betterment of Afrezza and PWDs. Just pointing out that its a heck of a lot easier said than done.
If I was going to do it, I'd be quiet about it. I'd announce it when it was submitted to the ADA Expert Committee, and not before. There is no need to set expectations that may not be able to be met or inviting scrutiny from parties who might have a vested interest in the change NOT happening. |
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Post by cretin11 on Sept 30, 2024 11:52:02 GMT -5
Well yeah, most things in life are easier said than done but that's the point. Highly paid executives get things done that are not "easy" but are worthwhile and will lead to success for the company. SoC is such a thing. We have known this for many years, we have been discussing it here for many years, and it would shock and dismay us if MNKD were not also discussing it and even obsessing over it. Because not only would it lead to great success for the company (and its shareholders), but it would dramatically increase positive outcomes for PWDs on a large scale.
I agree with you that being quiet about it is fine, so as not to set expectations that might not be met and therefore be viewed as failure. So hopefully the effort is being made, it has taken longer than we all hoped and expected. I seem to recall acknowledgement by MNKD previously that SoC was a goal (and again, how could it not be?). Either they have been working stealthily on it since then or they gave up. We should all be able to agree that hopefully it's the former and not the latter, correct?
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Post by prcgorman2 on Sept 30, 2024 12:05:25 GMT -5
The SoC is a kind of technical best practice guideline. It is not a law, or regulation. I assume getting a change to the SoC is partly scientific and partly political. If it was me, I’d quietly be working the room trying to understand how best to make progress, and who knows, maybe that is the process that yielded the 3 Afrezza trials.
What I would not do is openly declare that intention potentially making it much harder than it might otherwise be. This is why I asked for a reference. I don’t believe it exists and would be surprised and perhaps a little dismayed if it did. To me it would imply unhelpful hubris.
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Post by cretin11 on Sept 30, 2024 12:22:30 GMT -5
I would not be dismayed by a MNKD exec (whether it be the CEO or the CMO) stating the intention to improve the SoC by incorporating Afrezza. After so many years of silence on it (unless somebody can find a recent reference), it would be a relief to know they haven't given up on the intention. It would be a sign of confidence and belief in the efficacy of Afrezza, not hubris. Hubris implies excessively prideful, arrogant or overconfident, but IMO Afrezza is so good that there's nothing excessive or arrogant about expressing confidence in it.
When i have a few minutes i'll try to find a reference, but i seem to recall MNKD stating the SoC change as a goal. It was one of those old "mango upcoming catalysts" which i realize carries no weight as most of those things never panned out.
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Post by sayhey24 on Sept 30, 2024 12:26:44 GMT -5
No - they are bundling the results with the kids data and as they say “We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025.” I don't know what gestational data will be available by March but those results will be a slam dunk. The goal is SoC changes which will then bring insurance. I recall label changes (governed by the FDA) were a goal. I don't recall anyone at MannKind saying (recently) that getting changes to the SoC is a goal of the INHALE-1, INHALE-3, and gestational diabetes trials.
I gave ChatGPT the following input:
"The American Diabetes Association (ADA) publishes a diabetes Standard of Care (SoC). Who and what is required to make changes to the ADA SoC?"
Here was the output:
"Changes to the American Diabetes Association (ADA) Standards of Care (SoC) are made through a rigorous process involving input from a panel of experts in the field of diabetes care, including researchers, clinicians, and medical professionals. The ADA convenes an Expert Committee that reviews the latest scientific evidence and research on diabetes treatment and management. Any proposed changes undergo extensive peer review, ensuring they align with current clinical practices and research findings. The recommendations are then approved by the ADA's Professional Practice Committee (PPC) before being incorporated into the SoC."
I'm not saying a change to the ADA SoC prioritizing Afrezza shouldn't be a goal, but I don't think that's been publicly stated by MannKind management although perhaps Dr. David Kendall said words to that effect before he left MannKind a few years ago. I would really like to know if changing the SoC is indeed a goal. If you can provide a reference where it is stated changing the SoC is a goal of the current trials, that would be really great.
There are three problems with afrezza; label; SoC; cost. I may have mentioned that before. The label is within the control of MNKD. To fix the cost, Mike does not want to reduce the price. He wants insurance coverage. He is not getting insurance coverage until afrezza has a bigger role in the SoC. He would also like to get rid of the pre auths with Medicare. Thats not happing until we have SoC changes. The big problem with getting SoC changes is Big Pharma's control. Dave Kendal told us day 1 afrezza needs to be the standard of care. That was the goal and still is. Then again Dave slipped out the back right before Mounjaro started reporting results. I am sure the last thing Lilly would have wanted is their ex-VP showing afrezza getting better A1c results than Mounjaro with the T2s. To bad because Dave told us this was the easiest job he ever had. |
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