JERUSALEM (TheStreet) -- You're looking at the data which supposedly supports Oramed Pharmaceuticals' (ORMP) claim last week that its experimental insulin pill ORMD-0801 is safe and well tolerated, based on the positive outcome of a small and short (one week) phase IIa study.
The slide is hard to read but its shows adverse events reported by 40% of type 2 diabetics treated with the high dose of ORMD-0801. The adverse event rate in the low-dose ORMD-0801 arm was 30%. Fifty percent of the placebo-treated patients reported adverse events.
Ten patients were treated in each arm -- 30 patients total. For one week.
And from this, Oramed says, "The study clearly shows that ORMD-0801 is safe and well tolerated."
Really? I'd love to see the statistics supporting Oramed's claim. Of course, they're missing from the chart.
Also missing is any disclosure of ORMD-0801's efficacy. The company claims all secondary endpoints of the one-week study were achieved but no data or proof has been provided.
Take a look at the list of secondary efficacy endpoints for the phase IIa study listed by Oramed on its short slide deck:
It's a shorter list of secondary endpoints compared to the description of the ORMD-0801 study on ClinicalTrials.gov. Most importantly, Oramed disappears the efficacy endpoints comparing ORMD-0801 to placebo.
There's an interesting story behind how I found these ORMD-0801 slides.
Oramed issued its press release announcing positive results from the phase IIa study last Thursday Jan. 30, but neglected to include any real data. I emailed Oramed's media handlers, asking them to share actual ORMD-0801 data from the study, as the company had promised three days earlier. I didn't hear back from anyone Oramed until Sunday, when I received an email from Michal Lazarus, the company's office manager. He directed me to the ClinicalTrials.gov listing for the ORMD-0801 phase IIa study (which doesn't have any of the data I had requested) and told me that results from the study would be presented at an upcoming scientific conference.
But then I went hunting on Oramed's web site and found, tucked away at the bottom, of a this page, a link to the slides I shared above.
Why didn't Lazarus point me to the data slides? It's as if Oramed doesn't want anyone to see the actual data from the ORMD-0801 study, or at least, make it difficult to find them.
Oramed's handling of the ORMD-0801 data smacks more of stock promotion than credible drug development. These latest insulin pill data demonstrate nothing, says Diabetic Investor's David Kliff, a veteran analyst of diabetes drug development.