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Post by Deleted on Sept 5, 2017 21:30:57 GMT -5
So they are using a GLP agonist and not insulin. Beta cells are overworked in T2s; it sounds logical that a continuous supply of GLP will only accelerate the depletion of the remaining beta cells.
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Post by uvula on Sept 6, 2017 5:42:13 GMT -5
So is oramed just a scam to defraud investors and provide salaries to people for a few years? I can see how little investors can be suckered but surely large investors wouldn't fall for this. Do they have any large investors?
I suspect it started as an honest effort to see if oral insulin would work.
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Post by sayhey24 on Sept 6, 2017 7:03:35 GMT -5
Just curious, why specifically do people here consider it a joke? Are they misrepresenting the technology in some way? Is it unlikely to get approved for some reason? And before we get the usual... yes, Afrezza is great. Let's just accept that all of us that hold shares believe that. Wanting to discuss Oradmed specifically in this thread. DBC - what do you think the PK profile for this will look like? Maybe if they are lucky RHI but who knows and how predictable will it be depending on the type of food in the gut, pizza vs and orange? I would love to see the CGM profiles on this. Whatever it is it is not an insulin which mimics natural pancreatic first phase release. Could it replace a basal, who knows? T2s do not need a basal if started early on afrezza before their beta cells are burned out. The main issue for T2s is real time meal time insulin spikes. Only one product currently addresses that and its not Oramed. T1s needing corrections need something really fast and again thats afrezza, not an RAA and surely not Oramed. |
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Post by sayhey24 on Sept 6, 2017 7:09:36 GMT -5
So they are using a GLP agonist and not insulin. Beta cells are overworked in T2s; it sounds logical that a continuous supply of GLP will only accelerate the depletion of the remaining beta cells. Dr. Ralph DeFronzo or as I call him "The Father of Metfromin" in the U.S. has a trial going on in Qatar. He says he is actually getting beta cell regeneration using the GLP-1 and TZD. Al Mann claimed the same with afrezza. I think both are correct. Of the two IMO afrezza is a much faster and safer approach but what DeFronzo is confirming is beta cell regeneration. What Oramed is I have no idea. I thought it was insulin. |
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Post by liane on Sept 6, 2017 7:24:43 GMT -5
Oramed is insulin, but in some way protected from digestion from acids and enzymes.
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Post by mnholdem on Sept 6, 2017 8:30:03 GMT -5
www.oramed.com/wp-content/uploads/2017/06/OramedCorpPres-June-2017.pdf
www.oramed.com/investors/corporate-presentation/
Excerpt:
An Unsolved Challenge: Proteins and Peptides Do Not Survive the Digestive System
- Harsh pH: Stomach acidity cleaves and shreds protein
- Protease attack: Proteases attack and break down proteins
- Absorption barrier: Most therapeutic proteins fail to be absorbed via the intestinal wall (barrier)
Oramed Technology Protects Drug Integrity and Increases Absorption
- pH Shield for passage through stomach: pH sensitive enteric coating protects capsule contents
- Protease protection: Protease inhibitors stave off and protect the active agent from protease attack
- Absorption enhancement: Assists the permeation of proteins/peptides across intestinal membrane and into bloodstream
---
MnHoldem Note: I posted this thread about Oramed's meeting with the FDA as a reminder that MannKind Corporation has a limited window of opportunity to disrupt the diabetes treatment industry. Regardless of whether Oramed is successful in the FDA trials, there likely will be new technologies and Technosphere patent expirations to contend with in the future. CEO Castagna has only a few years (3-5) to propel Afrezza to become a major player in the market....perhaps THE major player, IMHO.
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Post by liane on Sept 6, 2017 8:40:57 GMT -5
I don't know what their "absorption enhancement" is. I'd be worried if it made the intestinal wall permeable to insulin, it might make it permeable to other large proteins - things that have no business crossing the intestinal wall - creating a leaky gut syndrome.
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Post by dreamboatcruise on Sept 6, 2017 9:11:01 GMT -5
Just curious, why specifically do people here consider it a joke? Are they misrepresenting the technology in some way? Is it unlikely to get approved for some reason? And before we get the usual... yes, Afrezza is great. Let's just accept that all of us that hold shares believe that. Wanting to discuss Oradmed specifically in this thread. DBC - what do you think the PK profile for this will look like? Maybe if they are lucky RHI but who knows and how predictable will it be depending on the type of food in the gut, pizza vs and orange? I would love to see the CGM profiles on this. Whatever it is it is not an insulin which mimics natural pancreatic first phase release. Could it replace a basal, who knows? T2s do not need a basal if started early on afrezza before their beta cells are burned out. The main issue for T2s is real time meal time insulin spikes. Only one product currently addresses that and its not Oramed. T1s needing corrections need something really fast and again thats afrezza, not an RAA and surely not Oramed. My first line look at anything is always to see what they are claiming. Trying to figure out if the claims might be false is secondary. They do claim that their 801 mimics the first phase and with a high concentration spike going directly through portal circulation into liver, which if they have figured out a way of getting insulin safely transported through intestines and absorbed, would be a trick not even inhaled can pull off. The concentration in portal vein going into liver is 3 or more times higher than in the general circulation for endogenous insulin. I don't know dosing instructions, so perhaps the issue you raise is simply solved by predosing enough to have the insulin largely absorbed before any slow digesting food hits. Not everything I read in their material seems consistent to me (though so far just quick skim), so I'm still taking it with grain of salt, though never totally dismiss something until I can see a reason to conclude it is BS. |
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Post by peppy on Sept 6, 2017 9:15:20 GMT -5
DBC - what do you think the PK profile for this will look like? Maybe if they are lucky RHI but who knows and how predictable will it be depending on the type of food in the gut, pizza vs and orange? I would love to see the CGM profiles on this. Whatever it is it is not an insulin which mimics natural pancreatic first phase release. Could it replace a basal, who knows? T2s do not need a basal if started early on afrezza before their beta cells are burned out. The main issue for T2s is real time meal time insulin spikes. Only one product currently addresses that and its not Oramed. T1s needing corrections need something really fast and again thats afrezza, not an RAA and surely not Oramed. My first line look at anything is always to see what they are claiming. Trying to figure out if the claims might be false is secondary. They do claim that their 801 mimics the first phase and with a high concentration spike going directly through portal circulation into liver, which if they have figured out a way of getting insulin safely transported through intestines and absorbed, would be a trick not even inhaled can pull off. The concentration in portal vein going into liver is 3 or more times higher than in the general circulation for endogenous insulin. I don't know dosing instructions, so perhaps the issue you raise is simply solved by predosing enough to have the insulin largely absorbed before any slow digesting food hits. Not everything I read in their material seems consistent to me (though so far just quick skim), so I'm still taking it with grain of salt, though never totally dismiss something until I can see a reason to conclude it is BS. I bet it does. dreamboat, would you like, 230, 460, or 690 units of insulin this morning with your breakfast? how would this item be made cost effective? They better have some super duper Hba1c's in the trials. turns out, health insurance doesn't want to pay, even if you say, it makes me gay.
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Post by dreamboatcruise on Sept 6, 2017 9:17:19 GMT -5
So they are using a GLP agonist and not insulin. Beta cells are overworked in T2s; it sounds logical that a continuous supply of GLP will only accelerate the depletion of the remaining beta cells. They have two active API candidates, one is GLP (901) agonist and the other is insulin (801). |
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Post by mango on Sept 6, 2017 11:35:18 GMT -5
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Post by peppy on Sept 6, 2017 12:06:22 GMT -5
Outcome Measures
1. Primary: Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements. [ Time Frame: Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day) ]
The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.
2. Secondary: The Effect of ORMD-0801 on Mean 24-hour Glucose [ Time Frame: Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day) ]
Results not yet reported. Anticipated Reporting Date: 09/2017
3. Secondary: The Difference of Mean (mg/dL) Fasting Glucose From Baseline to Week 4 [ Time Frame: Study day 1 (± 1 day) through Study day 29 (± 1 day) ]
Results not yet reported. Anticipated Reporting Date: 09/2017
4. Secondary: Effect of ORMD-0801 on Mean Daytime Glucose [ Time Frame: Study day 1 (±1 day) through Study day 29 (± 1 day) ]
Results not yet reported. Anticipated Reporting Date: 09/2017
5. Secondary: The Effect of ORMD-0801 on Changes in HbA1c [ Time Frame: Study day 1 (± 1 day) through Study day 29 (± 1 day) ]
Results not yet reported. Anticipated Reporting Date: 09/2017
Time Frame
eight (8) months
Study First Received: July 8, 2015
Results First Received: October 31, 2016
Last Updated: February 19, 2017
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Post by mango on Sept 6, 2017 12:30:10 GMT -5
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Post by mango on Sept 6, 2017 12:31:55 GMT -5
Do they not have a pk/pd graph to look at? If not I could only wonder why not 😐
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Post by mango on Sept 6, 2017 12:36:29 GMT -5
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