01/26/2014 by BiotechInvest It looks like we have a new biotech star that suddenly shine - ORMP pps jump from single digits to $30 in a couple weeks after this company said that it designed and tested oral insulin pills. And everybody (almost) believed in this scam :-)
Why it's scam? Because if you search for ORMP patents you will find that these insulin pills have: 1) enteric coating; 2) they contain inhibitors for intestinal enzymes; 3) the delivery agents are bile acids and salts.
And what it is mean?
Tmax for these pills will be 2-3 hours (if any), insulin bioavailability is close to 0 i.e. 0.1-0.5% (so pills need giant amount of insulin loaded to be effective), enzyme inhibitors will influence food digestion, the bile acids will induce leakage of gut walls in order to deliver insulin in blood and in portal vein (normally proteins and even peptides never penetrate into blood, only their metabolism products i.e. amino acids penetrate into portal vein).
After traveling through the gastrointestinal tract in its encapsulated form, the insulin is released in the small intestine. From there, it is ferried to the liver via the portal vein.
Even if these insulin pills deliver insulin the number of non-responders will be huge, FDA will never approve pills containing intestinal enzymes, bile acids and salts will induce a leaky gut that will lead to ulcerative colitis (UC) and Crohn’s disease (CD) that are two main forms of Inflammatory Bowel Disease (IBD). When the truth about ORMP scam will be revealed?
Very soon, when the company will publish real results for insulin pills trial.
Because now they have only these data:
"ERUSALEM, Dec. 20, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.
Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours. Patient responses positively correlated with administered doses, as did the duration of the effect.
"Based on these and the notable results from our previous oral insulin trials in type 1 diabetes, we continue to move forward with this indication in parallel to our advanced clinical studies in type 2 diabetes," commented CEO Nadav Kidron."
Actually they never publish any real PK/PD data but promised to do it in January. Well, let's wait...
Sure that data will be devastating for ORMP pps (it's still around $20).
And what is about price for insulin tablets?
According ORMP published paper insulin pills contain 8 mg (or 192U) of insulin i.e. price of 1 tablet is around $125 - so 3 tablets per day $500 away.
And what is the benefit of these tablets?
"Treatment with ORMD-0801 was associated with a significant 24.4% reduction in the frequencies of glucose readings .200 mg/dL (60.167.9% pretreatment vs. 45.464.9% during ORMD-0801 treatment; p = 0.023) and a significant mean 16.6% decrease in glucose area under the curve (AUC) (6605565547 mg/dL/24 hours vs. 5506063068 mg/dL/24 hours, p = 0.023), with a greater decrease during the early evening hours."
16% decrease in glucose AUC for $500 per day? Or $182,500 annually?
Will insurance pay for this 16% almost $200K per year? Never.
So, what they gonna say at January 30?
1)Well, tablets 100% safe - because only 1-2U of insulin is absorbed (bioavailability <0.5%)
2) PK/PD - Tmax - 2-3 hours (if any), Cmax - almost not-distinguished from background (BLQ)
3) No one hypo event (1-2U of insulin will never induce it)
4) Glycated hemoglobin (HbA1c) not changed
Conclusions: I have ORMP shorted at $28 (first short was too early at $12 so I covered it soon when an "investomadness" attack happened) and will wait for a complete crash i.e. below $4-5. Sure that ORMP management and employee are already rich because they sold their shares and options at highest. SEC should investigate this Ponzi.
01/30/14 by BiotechInvest
Well, they fooled investors again
"The one-week study of 30 patients also met safety goals, the Jerusalem-based company said in a statement today. Oramed plans to follow the mid-stage trial with another study later this year.
“The results we announced today give us confidence about the chances of success in a bigger trial going forward,” Chief Executive Officer Nadav Kidron said at a press conference today at the Tel Aviv Stock Exchange. “We are also excited about the potential of this drug for type 1 diabetes.”
Of course, these pills 100% safe. Because of 0% bioavailability of insulin. But where are PK/PD data? It looks like that have nothing to show. So all this game was arranged by some boys with money - firstly to make a noise, then pump the stock and make big money. Small investors are fooled again and will lose money in this pyramid. 02/03/2014 by BiotechInvest
I should say Bravo to Adam F. for his brave opinion about ORMP:Oramed's Oral Insulin Pill Data 'Completely Worthless'
BY Adam Feuerstein | 02/03/14 - 09:34 AM ESTBut worthless is too kind for ORMP scam and fraud... Insulin pill data is just stupid and only morons may think that an eating 8mg of insulin 3 times a day during 1 week may produce any data (even safe one). Besides of insulin these pills contain the compounds that perforate gut walls and allow peptides (and may be bacterial toxins) penetrate into patient blood. And 1 week is not enough for safety (may FDA scientific officers are become absolutely stupid? ). Once again: the reason why ORMP hide PK/PD is simple - it's impossibly to measure Tmax/Cmax when only 1U of insulin is absorbed (if any). The measuring of PD is also worthless when patients were using diabetes medications together with insulin pills. Investors that bought ORMP for >$5 are fooled and lose money -
04/07/16 by BiotechInvest
Oramed Completes Phase IIb Oral Insulin Study
Top-Line Data to be Released This Quarter
PR Newswire Oramed Pharmaceuticals Inc.
April 5, 2016 8:15 AM
Oramed Pharmaceuticals Inc. Watchlist
NASDAQ3:45 PM EDT
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that all follow-up visits in the Company's Phase IIb study of its oral insulin capsule, ORMD-0801, have been completed.
The double-blind, randomized Phase IIb study of 180 patients with type 2 diabetes was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States. The study was designed to generate ample data for both safety and efficacy endpoints. Top-line results are expected later this quarter.
"We are pleased with the successful and timely completion of this comprehensive study," stated Oramed CEO Nadav Kidron. "We look forward to reporting top-line results shortly."
This is a double-blind, randomized, 28-day clinical trial designed to assess the safety and efficacy of ORMD-0801 in type II diabetics. The trial will evaluate ORMD-0801 over a longer treatment period (28-day vs 7-day in the Phase IIa study) and will have statistical power to give greater insight into the drug’s efficacy.
The Phase IIb trial was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States.
The primary objective is the effect of ORMD-0801 on weighted mean night time glucose levels based on 2 nights of Continuous Glucose Monitor (CGM) data by comparison of the mean % change between baseline and week 4 of ORMD-0801 treatment and placebo groups. Safety and tolerability will also be assessed.
Top line data are expected to be available in 2Q16. We estimate a pivotal Phase III trial could start in late 2016 or early 2017 if Phase IIb data are positive.
Safest strategy will be to sell at high before trial results release (pps driven by run up can reach $10). ORMD-0801 will be definitely very safe but efficacy can be very modest. ORMP uses very smart trick - dose patients with insulin pills that will absorb in intestine i.e. several hours after swallow (late evening and night). So, the measuring of weighted mean night time glucose based on 2 nights of CGM data may show some significant changes. Question is can ORMP fool investors and persuade them to believe in "positive" Phase 2 results if Primary Outcome Measures i.e. weighted mean night time glucose levels based on 2 nights of Continuous Glucose Monitor will show very low difference between placebo and treated arm group? Depend on how Bloomberg and other will interpret this data. ORMP Ph2 Other Outcome Measures:
The effect of ORMD-0801 (Dose 1 insulin and Dose 2 insulin pooled and individually) on changes from baseline to Week 4, as compared to placebo, in HbA1c. [ Time Frame: Study day 1 (± 1 day) through Study Day 29 (±1 day) ] [ Designated as safety issue: No ]
exploratory outcome measure
But 1 months of treatment can't significantly change HbA1c. FDA will ask ORMP to measure HBA1c in Ph3 trial (if any) after 3 months of insulin pills treatment and it will be last nail for ORMP scam.
05/18/16 by BiotechInvest Well, the results are positive and you can call it a victory but it's a Pyrrhic victory. I'm not sure that even Bloomberg can present it as a "breakthrough in diabetes treatment". Looks like that we will have a massive sell off today on those "positive results". Well, it's always a risk to play with scam and some investors will get a lesson today. I'm selling all residue shares right now at market.
"This US based double blind, 28 day, randomized study of 180 adult type 2 diabetic patients showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts (p=0.0268). The study additionally demonstrated a good safety profile with no drug related serious adverse events."
Conclusion: ORMP is done. Even if they go to Phase 3 their pills are doomed to fail it because in Phase 3 FDA will ask to measure HbA1c during 3 months:
What is glycated hemoglobin HbA1c? It's a hemoglobin protein inside of red blood cells. HbA1c % is a results of glycation process i.e. covalent bonding of a protein with a sugar molecule, such as fructose or glucose, without the controlling action of an enzyme. Normal levels of glucose produce a normal amount of glycated hemoglobin. As the average amount of plasma glucose increases, the fraction of glycated hemoglobin increases in a predictable way. The test is limited to a three month average because the lifespan of a red blood cell is three months.
In simple words HbA1c shows how many hours patient had high glucose level per 3 months (2160 hours). Also it shows how high was average glucose level (see table below):
(%) HbA1c (mmol/mol) eAG (estimated average glucose) (mmol/L) (mg/dL)
5 31 5.4 (4.2–6.7) 97 (76–120)
6 42 7.0 (5.5–8.5) 126 (100–152)
7 53 8.6 (6.8–10.3) 154 (123–185)
8 64 10.2 (8.1–12.1) 183 (147–217)
9 75 11.8 (9.4–13.9) 212 (170–249)
10 86 13.4 (10.7–15.7) 240 (193–282)
11 97 14.9 (12.0–17.5) 269 (217–314)
12 108 16.5 (13.3–19.3) 298 (240–347)
13 119 18.1 (15–21) 326 (260–380)
14 130 19.7 (16–23) 355 (290–410)
15 140 21.3 (17–25) 384 (310–440)
16 151 22.9 (19–26) 413 (330–480)
So, if night insulin pills decrease night glucose level only for 1-2 hours and only 20-30% in comparison with placebo group it will never significantly change HbA1c (compare 180 h with only 20-30% decreasing glucose with 2160 hours and most of them day hours when glucose level is high because of multiple food consumption).