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Post by hellodolly on Jun 22, 2023 5:13:52 GMT -5
MannKind Launches Inhale-3 Study to Address the Most Important Unmet Need Today in Adults Living With Type 1 Diabetes (T1D)Large trial in adults comparing A1c and mealtime control when switching from injectable insulin or pumps to inhaled insulin (Afrezza® (insulin human) Inhalation Powder) Time-in-range during waking hours remains a challenge despite advances in diabetes technology Lack of mealtime control is the underlying issue preventing approximately 80%(1) of the T1D population from achieving A1c goal DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 22, 2023 (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, announced today that it is launching the INHALE-3 study to address the most important unmet need today in adults living with T1D. “This large study is planned to assess improvement in mealtime glycemic control, which continues to be a serious challenge for the majority of people living with type 1 diabetes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “INHALE-3 will study the effect of Afrezza on mealtime control, which has a time-action profile that closely mimics that of physiologic insulin in the first 120 minutes after a meal.” INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study will randomly assign participants over 18 years of age with T1D who are using MDI, an automated insulin delivery (AID) system, or a pump without automation to either continue their usual care or adopt an insulin regimen of basal injections plus Afrezza. Both arms will utilize continuous glucose monitoring to assess mealtime control and A1c levels. “People living with diabetes deserve options and innovation that can reduce burdens and provide impactful glucose control,” said Dr. Irl B. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington. “As protocol chair for the INHALE-3 study, I am looking forward to working with leading clinical sites across the country to collect meaningful data regarding the use of inhaled insulin.” Approximately 120 patients will be randomized in the study conducted in collaboration with the Jaeb Center for Health Research and 20 sites across the country, including the Joslin Diabetes Center, the Barbara Davis Center for Diabetes, the University of Washington Diabetes Institute, Northwestern University, Mayo Clinic, and University of North Carolina Diabetes Care Center. For more information on INHALE-3 and the list of participating sites, please visit: clinicaltrials.gov/ct2/show/NCT05904743.
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Post by cjm18 on Jun 22, 2023 5:47:54 GMT -5
Nice. Is 120 patients enough to move the needle?
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Post by akemp3000 on Jun 22, 2023 6:04:04 GMT -5
The impressive collaboration of participating sites ensures the results will become widely known if they come in as expected. Combining this with pediatric approval should certainly move the needle. Nice to see a brighter light at the end of this tunnel knowing it's not just another train.
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Post by prcgorman2 on Jun 22, 2023 6:19:00 GMT -5
Nice. Is 120 patients enough to move the needle? Excellent question. I’m curious to learn agedhippie view on your question. A follow on question in my mind is, if the trial isn’t likely to “move the needle”, why bother? I’ll channel radgray and borrow from a scene in Jurassic Park, “They’re testing the fences for weaknesses, systematically”. On this board we’ve talked about “V-Go in the bag of MannKind sales reps” as something that helps the reps tell a more compelling story of MannKind products. The FDA restricts what you can say about a drug you’re selling. One of the things you’re permitted to do is talk about results from studies. Results from smaller studies can also be used to inform and adjust larger studies designed, specifically, to “move the needle”. The bottom-line is, there can be value in smaller studies, and for sure they can cost less which is important to a company feeling pressure to show a profit. |
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Post by Clement on Jun 22, 2023 6:40:20 GMT -5
How long does this take? Two years to get results published and available to the public?
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Post by prcgorman2 on Jun 22, 2023 8:07:42 GMT -5
17 weeks with a 13 week extension. A family member recently was asked to participate in a drug trial for an FDA-approved drug. They declined the offer. Not sure how often that happens, but I assume it’s more challenging to find 120 participants than just asking 120 persons with Type 1 diabetes. It was a medical professional that shared the paperwork and that would assist with monitoring patient progress and the paperwork was full of medical information about the trial goals and possible harms that might result, and then lots of information prepared by attorneys skilled in writing proposals for drug trials. Assuming MannKind already has all of the trial defined and paperwork ready to distributed to the clinics and folks ready to meet with clinic professionals and get the trial going, results might be available in 2024 is my uneducated guess.
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Post by agedhippie on Jun 22, 2023 9:01:12 GMT -5
Nice. Is 120 patients enough to move the needle? Excellent question. I’m curious to learn agedhippie view on your question. ... Yes, that's a viable sized trial. This is exactly the sort of trial that needs to be done to address the Type 1 market. The only thing I would say is that they should pick a target rather than " using MDI, an automated insulin delivery (AID) system, or a pump without automation" because that leaves open the question of how much the MDI dragged down the whole arm and how Afrezza would have done against the AID pumps. The risk is that the non-Afrezza arm gets fragmented and the fragment size becomes to small. |
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Post by prcgorman2 on Jun 22, 2023 9:10:22 GMT -5
Excellent question. I’m curious to learn agedhippie view on your question. ... Yes, that's a viable sized trial. This is exactly the sort of trial that needs to be done to address the Type 1 market. The only thing I would say is that they should pick a target rather than " using MDI, an automated insulin delivery (AID) system, or a pump without automation" because that leaves open the question of how much the MDI dragged down the whole arm and how Afrezza would have done against the AID pumps. The risk is that the non-Afrezza arm gets fragmented and the fragment size becomes to small. Is it too late to change the target? i.e., do adjustments such as you suggest get made to trials as they're getting started? Is that kind of change trivial or does it introduce complications? |
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Post by agedhippie on Jun 22, 2023 9:17:37 GMT -5
How long does this take? Two years to get results published and available to the public? More or less. It takes a while to recruit that number of people. There are companies that specialize in logistics including recruitment for trials, that's Jaeb Center for Health Research. The most interesting thing for me is that Irl Hirsch is the study chair so his name will be on the paper. Given his status in the medical research field this more or less guarantees publication in Diabetes Care, and that the paper will get read. I could see this as a possible 2025 ADA paper (trial ends October 2024 + 6 months for the QC approval lands just about perfectly.) |
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Post by agedhippie on Jun 22, 2023 9:19:14 GMT -5
Yes, that's a viable sized trial. This is exactly the sort of trial that needs to be done to address the Type 1 market. The only thing I would say is that they should pick a target rather than " using MDI, an automated insulin delivery (AID) system, or a pump without automation" because that leaves open the question of how much the MDI dragged down the whole arm and how Afrezza would have done against the AID pumps. The risk is that the non-Afrezza arm gets fragmented and the fragment size becomes to small. Is it too late to change the target? i.e., do adjustments such as you suggest get made to trials as they're getting started? Is that kind of change trivial or does it introduce complications? They can adjust the proportions in the recruitment phase. There are no fixed numbers quoted within the arm. |
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Post by prcgorman2 on Jun 22, 2023 10:12:10 GMT -5
Is it too late to change the target? i.e., do adjustments such as you suggest get made to trials as they're getting started? Is that kind of change trivial or does it introduce complications? They can adjust the proportions in the recruitment phase. There are no fixed numbers quoted within the arm. Your generosity to this board is immense. You and @kippyt are awesome. Thank you very much. |
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Post by hellodolly on Jun 22, 2023 12:06:35 GMT -5
30 weeks potentially is roughly 8 months until completion. That takes the study out to early 2024. Early analysis released by May 2024 at the Annual Shareholder Meeting and the June 2024 ADA?
I'm curious what role the PHIII India trials may have played in this trial design since Mike stated they saw real good numbers (tentatively) in that trial. Improvement in meal time glycemic control is the emphasis of this study and what did the see in India, without pumps and only insulin?
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Post by Clement on Jun 22, 2023 12:34:14 GMT -5
30 weeks potentially is roughly 8 months until completion. That takes the study out to early 2024. Early analysis released by May 2024 at the Annual Shareholder Meeting and the June 2024 ADA? I'm curious what role the PHIII India trials may have played in this trial design since Mike stated they saw real good numbers (tentatively) in that trial. Improvement in meal time glycemic control is the emphasis of this study and what did the see in India, without pumps and only insulin? Please add the amount of time it takes to sign up all 120 qualified trial participants.. |
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Post by mymann on Jun 22, 2023 12:52:11 GMT -5
Another useless small study to show share holders Mike's doing his job and justifying his pay and reinforcing job security.
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Post by hellodolly on Jun 22, 2023 14:22:01 GMT -5
30 weeks potentially is roughly 8 months until completion. That takes the study out to early 2024. Early analysis released by May 2024 at the Annual Shareholder Meeting and the June 2024 ADA? I'm curious what role the PHIII India trials may have played in this trial design since Mike stated they saw real good numbers (tentatively) in that trial. Improvement in meal time glycemic control is the emphasis of this study and what did the see in India, without pumps and only insulin? Please add the amount of time it takes to sign up all 120 qualified trial participants.. I was thinking since these are primarily at well established diabetes centers, it won't take as long as it normally would going out and looking for them at endocrine facilities, doctors offices, GPs, etc. |
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