|
|
Post by sayhey24 on Dec 11, 2022 12:50:01 GMT -5
Peter Richardson??? How long has he been gone? If this works and prevents the vomiting and can demonstrate the same weight reduction or satiety effects seen with long-acting analogues MNKD could have a block-buster which has already gone through phase 1s. Too bad its been sitting in the freezer all these years and seemed to be forgotten. I wonder if Mike is planning on pursuing this or if we are just keeping up to date with updating the patent. It would make sense to pursue this if we want to expand and grow the Endocrine Business Unit and we already know that GLP-1 works with Technosphere. IDK - I think its more than just a coincidence that after 15 years this shows up on the radar after proboards starts talking about it and GLP1/afrezza trials. IDK, maybe proboards found a hidden gem or as Dave Kendall would say a "nugget of gold". IMO maybe we found a wagon load of gold bars. Time will tell if Mike does anything with this or if he is too busy. We have been talking about a GLP1 study with Mounjaro and Ozempic against afrezza. This TS GLP1 would provide another potential arm. Could you even mix TS GLP1 with afrezza in the same cartridge for single inhalation? The thing is you really want to limited the "insulin" released by the T2 pancreas and by combining both afrezza/GLP1 maybe there is an advantage, IDK? Can TS GLP1 provide the same satiety effects as the long acting GLP1s. If so this might provide a blockbuster in the diet space by eliminating the vomiting and the injection. I can't believe that a bunch of BPs would not be lining up at the door to license this to push through Phase 2 and 3s. |
|
|
|
Post by sayhey24 on Dec 11, 2022 12:53:54 GMT -5
If they can make this work it would be huge. The problem they have to solve is that Technosphere is really good at fast absorption and that is something you don't want with GLP-1 drugs. The half life is really short and a lot of the work with injectables is around getting an extended release like a basal insulin. Did you read through the patent info? Richardson addresses this and discusses short acting and long acting TS GLP1s. The short acting could potentially work with afrezza. The long acting would be used for weight loss. They have the potential of two different products both with no vomiting nor injection. |
|
|
|
Post by mango on Dec 11, 2022 13:39:09 GMT -5
The Phase 1 clinical trial has already been completed with positive results.
|
|
|
|
Post by sayhey24 on Dec 11, 2022 14:39:18 GMT -5
|
|
|
|
Post by bthomas55ep on Dec 11, 2022 14:39:50 GMT -5
The Phase 1 clinical trial has already been completed with positive results. Mango or Sayhey, are there any statute of limitations between the time you have a successful completion of a Phase 1 trial and you have to start phase 2? Or, is the FDA allowed to work with a company to decide whatever it wants? In other words, are they likely to require Phase 1 again? Thx |
|
|
|
Post by sayhey24 on Dec 11, 2022 14:45:32 GMT -5
The Phase 1 clinical trial has already been completed with positive results. Mango or Sayhey, are there any statute of limitations between the time you have a successful completion of a Phase 1 trial and you have to start phase 2? Or, is the FDA allowed to work with a company to decide whatever it wants? In other words, are they likely to require Phase 1 again? Thx Now that would be a question for Martin Shkreli. The short answer is no but this is Mannkind. IDK, has a company with what appears to be significant results from phase 1 put a potental blockbuster in the freezer only to be forgotten about for 15 years? The crazy thing is the other GLP1s have all turned into blockbusters and all have issues TS GLP1 might solve. |
|
|
|
Post by mango on Dec 11, 2022 14:54:58 GMT -5
The Phase 1 clinical trial has already been completed with positive results. Mango or Sayhey, are there any statute of limitations between the time you have a successful completion of a Phase 1 trial and you have to start phase 2? Or, is the FDA allowed to work with a company to decide whatever it wants? In other words, are they likely to require Phase 1 again? Thx It doesn’t matter how long it’s been. I think MannKind used the old inhaler in the trial though, but I still don’t think that would hinder them from picking back up at Phase 2 with the new inhaler. I could be wrong about that though. |
|
|
|
Post by letitride on Dec 11, 2022 15:23:54 GMT -5
I like where this is going especially as a combo with afrezza looks like a great way to enter the T2 market.
|
|
|
|
Post by mytakeonit on Dec 11, 2022 16:08:17 GMT -5
I believe that Mike C and MNKD wouldn't want to harp on the "weight loss" aspect ... because you will end up with people taking it just to lose weight. Definitely not where we want to be ... with possibility of law suits.
But, that's mytakeonit
|
|
|
|
Post by stevil on Dec 11, 2022 16:48:54 GMT -5
I believe that Mike C and MNKD wouldn't want to harp on the "weight loss" aspect ... because you will end up with people taking it just to lose weight. Definitely not where we want to be ... with possibility of law suits. But, that's mytakeonit Wegovy has been FDA approved for obesity. I've read on online physician messages boards that they're often getting patients approved for prediabetes as well if they have evidence of further metabolic syndrome with obesity even for the non-wegovy semaglutide. Obesity is probably the most prevalent disease in America. That's an indication you WANT to treat. Also, I havent looked into it at all but it would seem to me you wouldn't want Afrezza to get mixed with a GLP-1 or GIP as that could cause hypoglycemia. When they first came out, they were twice daily dosing. As aged said, they've been working on extending the duration since then. There is a GLP-1/basal formulation out there that I don't think many people prescribe. I suspect that's probably why you haven't seen novolog/humalog get mixed, either. I'm sure it's been thought about and considered. I highly doubt anyone is taking advice from this board. |
|
|
|
Post by mytakeonit on Dec 11, 2022 17:04:45 GMT -5
Do you think MNKD would prescribe techonosphere insulin to a non diabetic person so they can lose weight? I am worried that someone will ask a friend if they can "try" their inhaled insulin to see if they can lose some weight.
This definitely is not the intent of MNKD.
There are tons of products on the market for weight loss if that's what they want.
But, that's mytakeonit
|
|
|
|
Post by stevil on Dec 11, 2022 17:06:35 GMT -5
Insulin doesn't cause weight loss. Not sure why someone would do that...
|
|
|
|
Post by sayhey24 on Dec 12, 2022 8:12:08 GMT -5
I believe that Mike C and MNKD wouldn't want to harp on the "weight loss" aspect ... because you will end up with people taking it just to lose weight. Definitely not where we want to be ... with possibility of law suits. But, that's mytakeonit Wegovy has been FDA approved for obesity. I've read on online physician messages boards that they're often getting patients approved for prediabetes as well if they have evidence of further metabolic syndrome with obesity even for the non-wegovy semaglutide. Obesity is probably the most prevalent disease in America. That's an indication you WANT to treat. Also, I havent looked into it at all but it would seem to me you wouldn't want Afrezza to get mixed with a GLP-1 or GIP as that could cause hypoglycemia. When they first came out, they were twice daily dosing. As aged said, they've been working on extending the duration since then. There is a GLP-1/basal formulation out there that I don't think many people prescribe. I suspect that's probably why you haven't seen novolog/humalog get mixed, either. I'm sure it's been thought about and considered. I highly doubt anyone is taking advice from this board. I think Peter was thinking because it was afrezza it would be in and out so fast and get the liver involved so you would not get hypos. Maybe Mike will finally run a pilot study with Mounjaro, Ozempic, afrezza and TS GLP1. With the post covid studies there is a school of thought that the more you can keep the pancreas from releasing its "insulin" at mealtime the better. Can afrezza help suppress that release by getting into the system asap? Then the question is - is it better to have more afrezza and a pinch of GLP1 or more GLP1 and a pinch of afrezza or is afrezza better if used alone. If MNKD can market this GLP1/afrezza combo as a GLP1 maybe they can finally break into the T2 market. Of course this is where the AGPs showing better mealtime control comes into play. For diet - if Peter is correct and TS GLP1 can be used with a long acting GLP1 and if it can eliminate the vomiting, acute pancreatitis and injections it would seem MNKD would have a superior product. |
|
|
|
Post by agedhippie on Dec 12, 2022 8:59:06 GMT -5
I thought about mixing GLP-1 and Afrezza as well, but you end up with variable dosing and replicating the mess that is Mix insulin. The problem is that your ratio is fixed and that is problematic. The person who is insulin sensitive and needs GLP-1 is not going to get enough, and the person who is insulin resistant is going to get a ton of GLP-1 which is definitely not helpful. That's before you look at meal to meal dosage variances.
The patent more or less assumes you are going to take GLP-1 before and just after the meal. The option to extend the lifetime is to take a DPP-4, such as Januvia, to inhibit breakdown of the GLP-1 (this is how Januvia works as a diabetic med). However, that is not going to give you the duration of anywhere near the current generation of GLP-1 shots and has not been studied to the best of my knowledge in this context (extending external GLP-1 lifetime).
|
|
|
|
Post by sayhey24 on Dec 12, 2022 9:29:41 GMT -5
I thought about mixing GLP-1 and Afrezza as well, but you end up with variable dosing and replicating the mess that is Mix insulin. The problem is that your ratio is fixed and that is problematic. The person who is insulin sensitive and needs GLP-1 is not going to get enough, and the person who is insulin resistant is going to get a ton of GLP-1 which is definitely not helpful. That's before you look at meal to meal dosage variances. The patent more or less assumes you are going to take GLP-1 before and just after the meal. The option to extend the lifetime is to take a DPP-4, such as Januvia, to inhibit breakdown of the GLP-1 (this is how Januvia works as a diabetic med). However, that is not going to give you the duration of anywhere near the current generation of GLP-1 shots and has not been studied to the best of my knowledge in this context (extending external GLP-1 lifetime). IDK, I just remember Peter was so excited about this work. The thing is there seems to be "potential" for at least one (probably more) blockbuster but studies need to be done. Afrezza has not gotten the interest of another BP to partner but could this? The issue at hand is the T2 is not producing enough "good" insulin for the body's needs. We know if we dose early with afrezza we see significantly less "resistance" than if we wait and let the pancreas pump out its insulin and the BG spikes. We then need 2x maybe 3x the afrezza. We also know we still don't see the hypos. Is the GLP1 slowing down the "bad" insulin but letting more "good" insulin being released by the pancreas - that's a theory. However we really don't want the pancreas releasing anything until whatever is going on with the beta cells is pretty much cleared up. Thats what afrezza does but its not selling. Its one of the greatest marketing failures of all time and sure needs a Harvard case study about it. The problem at hand is MNKD does not know how to market afrezza. Its insulin. Mealtime insulin is the last step in the ADA step program. If MNKD can just add a pinch of TS GLP1 to the afrezza in the same cartridge can it now be sold as a GLP1 combo and fit into the existing ADA step program and become step 2? Will that pinch of GLP1 have any effect on appetite, IDK. The other issue is the cartridge can only hold so much powder and we also know people seem to cough a lot more with the 12u than the 4u. What I do know is WE started this conversation about a year ago concerning ADA2022 and Mounjaro and what Mike was going to do. Nearly a year later we see the patent was submitted for the 15 year old TS GLP1. Now, as we have discussed we need some pilot studies to answer some questions. My concern is Mike is more focused on V-Go and may not give TS GLP1 any resources. Maybe a BP partner will show up out of the ether. |
|
