Is Mannkind preparing to increase dosing to 30U to Improve efficacy outcomes. I may cost a little more to manufacturing 30U, but if it delivers better HbA1c results compared to 20U, it will improve the label and enhance commercial opportunities. Primary outcome completion date is scheduled for October 2013 and the trials completion date is March 2014, both in time to hopefully have the new dosing available for Afrezza launch....
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
This study is not yet open for participant recruitment.
Verified July 2013 by Mannkind Corporation
Sponsor: Mannkind Corporation
Information provided by (Responsible Party):
First received: July 15, 2013
Last updated: July 26, 2013
Last verified: July 2013
History of Changes
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A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
Condition Intervention Phase
Drug: Technosphere® Insulin 10U + 20U
Drug: Technosphere® Insulin 30U
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
Please stop with the A1c nonsense. Afrezza worked perfectly. It is not suppose to control A1c. Thats what basil is for. The problem with todays mealtime insulins is they work too slow and last too long so they get in the way of the basil. Doctors don't give enough basil for fear of hypos. 171 showed even with more basil they had less hypos. As the endocrinologist fine tunes basil for each patient better A1c will be seen by giving more basil and they will still see less hypos. A1c level is a marathon not a sprint. Afrezza is a sprinter. Baslin is for marathons.
Sentiment: Strong Buy
This is VERY interesting - I find the July date to be very telling, right around the time they would have figured out that 20 units was a huge mistake. I think management already sees the writing on the wall on this. 30 units is what is required to obtain the efficacy they had been touting for the past year.
BINGO. And what happens when you have to inhale much more often just to have similar efficacy as Medtone? CV risk ratios change. Pulmonary data changes. More and more powder goes into the lungs for the same effect. I had an old post titled "It's all about the Dosing" or something like that where I tried to explain it. In the end, it makes proving bio = extremely difficult. But hey, they've been rejected twice already based upon their inability to prove bio =, so one more CRL for the same issue won't be a big deal to them.
You would think after two CRL's based upon an inability to prove bio =, that the bio = mistakes would lessen in this trial. But they keep making them. In their defense, it's not as easy as it may seem. To keep CV risk under 1.3, the knew the inhaler had to have less powder. And to gain commercial acceptance they needed a smaller inhaler. And to not price themselves out of the market like Pfizer, they need a cheap inhaler, etc. etc.
Unfortunately, it seems like they keep forgetting that they first have to prove bio = so they may want to make sure the inhaler changes are not too drastic next time. Or just submit the NDA using the Medtone inhaler and try to get approval for T2's after initial approval for T1's.
As you can see, this is another bio = study to prove that a 20 +10 dose is the same as a single 30 dose. It is not surprising that they are doing this in light of all the bio = issues arising from the 171 trial.
The results of this trial will unfortunately not be completed by the time MNKD submits its NDA so I'm not sure how much effect it will have on getting approved in Q1 2014 --- even if the results are heavily in MNKD's favor. Perhaps they will be able to supplement the NDA before an FDA decision, but it the results of this trial are necessary for approval, it will certainly push back PDUFA from Q1 2014 to later in the year.