Oramed Pharmaceuticals Inc.
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Eröffnet am: | 28.03.07 13:46 | von: OttomanRos. | Anzahl Beiträge: | 988 |
Neuester Beitrag: | 21.05.23 08:11 | von: Jürgen1964 | Leser gesamt: | 268.573 |
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Primary endpoint met:
ORMD-0801 was safe and well tolerated
Secondary endpoint met:
ORMD-0801 showed clinically meaningful reduction of liver fat from baseline at 12 weeks
Strong evidence for treatment of NASH using Oramed’s oral insulin
Wichtig!
...... meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.
https://oramed.com/...rial-with-its-ormd-0801-oral-insulin-candidate/
“These results paint an exciting picture for the potential of our oral insulin candidate to treat patients with both diabetes and NASH, a very serious condition with few treatment options,” said Oramed’s Chief Executive Officer, Nadav Kidron. “At the same time, we await the top-line data from our Phase 3 trial of oral insulin for T2D, which we expect in January 2023.”
Vom 21.12.2022
-- We expect to announce topline results in the next four weeks
https://oramed.com/oramed-letter-to-shareholders-december/
Denke, einige sichern den Anstieg. Das dürfte auch der Grund für den Kursrückgang sein.
The company said its phase 3 clinical trial (ORA-D-013-1) did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks.
The trial also did not meet its secondary endpoint, which assessed the mean change from baseline in fasting plasma glucose at 26 weeks.
There were no serious drug-related adverse events.
ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.
Phase3 Studie ORA-D-013-1 verfehlt den primären Endpunkt
"Oramed erwartet seine klinischen Aktivitäten mit oral verabreichtem Insulin für Typ-2-Diabetes nach enttäuschenden klinischen Studienergebnissen mit ORMD-0801 einzustellen."
https://oramed.com/...ormd-0801-for-the-treatment-of-type-2-diabetes/
Alles was die Insulin-Sache betrifft hat heute an Hoffnung sehr stark eingebüßt, weil das Prinzip in der Pipeline ja den gleichen Ansatz hat.
Mal sehen wie sich Oramed selber zur Zukunft äußert und wo sie noch Potential sehen. Da muss jetzt schnell ein statement kommen nach der Hiobsbotschaft von heute.