Oramed Pharmaceuticals (NASDAQ: ORMP) crashed 70% in pre-market trading on Thursday after the clinical-stage pharmaceutical company announced disappointing top-line results from its Phase 3 clinical trial that evaluated the efficacy of ORMD-0801 to placebo.
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This Phase 3 trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) which evaluated ORMD-0801 in 710 patients with Type 2 Diabetes (T2D) at 26 weeks.
This trial indicated that ORMD-0801 did not meet both the primary and secondary endpoints. The primary endpoint “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” while the secondary endpoint “assessed the mean change from baseline in fasting plasma glucose at 26 weeks.”
Since ORMD-0801 did not meet its endpoints, ORMP will discontinue its oral insulin clinical activities for T2D.
ORMP stock has slumped more than 10% in the past year.