Oramed Pharm - is a clinical stage biopharmaceutical company.
It looks dead after before the Ru war on the UA, right after corona crysis.
评论:
ORA-D-013-2: This trial will include T2D patients with inadequate glycaemic control who are attempting to manage their condition with either
diet alone or with diet and metformin or SGL2 monotherapy. A total of 450 patients will be recruited through 36 sites in the U.S. and 25 sites in Western
Europe and Israel. Patients will be randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at night; and placebo at night. The primary endpoint is
to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c over a 26-week treatment period, with
a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this trial in the U.S. in March
2021. In August 2021, we announced that over 25% of the 450 patients were enrolled and randomized.
We expect to receive the efficacy data from the trials after patients have completed the first 6 months of treatment. Safety will be further
monitored as patients will be exposed to the drug over an additional 6 months (total 12 months). The trial’s topline results are expected in 2022 and we
anticipate filing a BLA with the FDA in 2024. A BLA would grant us 12 years of marketing exclusivity from the date of approval in the U.S.
diet alone or with diet and metformin or SGL2 monotherapy. A total of 450 patients will be recruited through 36 sites in the U.S. and 25 sites in Western
Europe and Israel. Patients will be randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at night; and placebo at night. The primary endpoint is
to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c over a 26-week treatment period, with
a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this trial in the U.S. in March
2021. In August 2021, we announced that over 25% of the 450 patients were enrolled and randomized.
We expect to receive the efficacy data from the trials after patients have completed the first 6 months of treatment. Safety will be further
monitored as patients will be exposed to the drug over an additional 6 months (total 12 months). The trial’s topline results are expected in 2022 and we
anticipate filing a BLA with the FDA in 2024. A BLA would grant us 12 years of marketing exclusivity from the date of approval in the U.S.