The Easiest Prediction in Biotech This Summer

[Northerner]

MannKind (NASDAQ: MNKD ) is scheduled to release data for two phase 3 trials of its inhaled insulin, Afrezza, this month.

Nothing is for certain in biotech, but it looks to me like the extended phase 3 program has an extremely high likelihood of coming up positive. I'll be shocked if both trials don't meet their endpoints.

Why the clinical trials will be positive
Simply put, there isn't that much difference between the product MannKind studied in its previous successful phase 3 trials and the device used in its current trials, Affinity 1 and Affinity 2.

The new inhaler, dubbed Dream Boat, is smaller than MedTone, but there's little reason to think the underlying insulin will do anything differently once it enters the body.

http://www.fool.com/investing/general/2013/08/09/the-easiest-prediction-in-biotech-this-summer.aspx

MannKind thinks part of the reason why its A1C levels don't look quite as good stems from the way the two products change blood sugar levels. Rapid-acting injected insulins, such as Novo Nordisk's (NYSE: NVO ) NovoLog and Eli Lilly's (NYSE: LLY ) Humalog, tend to produce lower fasting blood sugar levels compared to Afrezza. Hypoglycemia -- low blood sugar levels -- is extremely dangerous, so the long-acting insulin that diabetics also use is adjusted so the patient's blood sugar level is high enough that the lows between meals don't become too low.

Since the fasting lows aren't nearly as low for patients taking Afrezza, patients can start with lower blood sugar levels. To produce parity, patients in the Affinity 1 trial are required to reduce their blood sugar level to a certain level before Afrezza or the rapid-acting insulin is tested.

Eh? Fast acting insulin produces lower fasting levels? Say what? 🙄 Does any of the above make any sense to anyone?

 

[Redkite]

It's nonsense isn't it! What have your fasting levels got to do with fast-acting insulin? They seem to be saying that people on humalog or novorapid need to have generally higher BG levels to avoid hypos! I have no faith in the idea of inhaled insulin.

 

[Northerner]

It's nonsense isn't it! What have your fasting levels got to do with fast-acting insulin? They seem to be saying that people on humalog or novorapid need to have generally higher BG levels to avoid hypos! I have no faith in the idea of inhaled insulin.

Nor me, especially if that is 'official' thinking on the phase III test criteria 😱 Which it may not be, of course, just a confused journalist who thinks it sounds good 🙄

 

[LeeLee]

If I were taking insulin, I would be worried about the consistency of inhalation as a delivery method. I have a lifetime of experience with asthma, for which inhaled drugs are the norm. Unless you get the technique right every time, the effective dose can vary widely. Something as simple as a common cold can make it hard to get the technique right, but with asthma you can quite safely have another puff (even the steroids). I wouldn't want to mess with a double dose of insulin! Any thoughts?

 

[Northerner]

If I were taking insulin, I would be worried about the consistency of inhalation as a delivery method. I have a lifetime of experience with asthma, for which inhaled drugs are the norm. Unless you get the technique right every time, the effective dose can vary widely. Something as simple as a common cold can make it hard to get the technique right, but with asthma you can quite safely have another puff (even the steroids). I wouldn't want to mess with a double dose of insulin! Any thoughts?

I wouldn't want it and don't really see why they are bothering. I think it will be a limited market, although I suppose there is a danger that it might be pushed to people who have problems with needles. I totally accept that there are genuine trypanophobics (needle phobics 😉), but how many people do you hear when you say you have to inject 'I have to inject insulin', respond 'I could NEVER do that!'? Most of them could, especially once they realised it doesn't actually hurt. I have the same scepticism as you about delivery of appropriate doses, and how on earth do you cater for the wide range of doses required by different people for different meals? There have been meals that I need 3 units for that I know others might need 10-15 units - would that mean more inhalations, leading to more margin for error in dose delivery? Far too uncertain for me! 😱

 

[trophywench]

Hee Hee, Alan. The wife of one of the Moderators on DSF says that and refuses to believe if she felt how I felt before my first insulin jab, she'd do absolutely anything bar none to try and stop it, and injections - even with boil it again hedgestake 12mm bodkins, and all that jazz !

Actually, I snapped back completely without thinking at the lady in the next bed to me in hospital on diagnosis, who said the typical, 'Urrggh - I'd DIE if I had to do that!'

'No, actually - you wouldn't, Bren ! But I ruddy well would, if I DIDN'T !'

And that's the stance I take with everyone ever since.

 

[AlisonM]

I have the same concerns about inhalers myself. I've had to use them in the past and know first hand how hard it is to ensure you get the correct dose every time. Even 'hardened' asthmatics like my gran couldn't do it. At least with an injection I know I'm getting the full dose. Why in heavens name don't they ask the potential 'end users' before they waste money on silly gimmicks like this?