Item 8.01. Other Events.
On February 26, 2020,
Oramed Pharmaceuticals Inc. (the “Company”) announced positive topline data from the second and final cohort of the
Phase IIb trial evaluating the efficacy and safety of its lead oral insulin candidate, ORMD-0801, at lower dose regimes, which
has the potential to be the first commercially available oral insulin capsule for the treatment of diabetes. The placebo-controlled,
double-blinded, randomized, 90-day dose-ranging phase IIb trial in type 2 diabetes patients with inadequate glycemic control on
oral antihyperglycemic agents, assessed the change in A1C, the primary efficacy endpoint, from baseline to week 12, as well as
safety endpoints, when ORMD-0801 was given in different regimens across three daily dose ranges (8 mg, 16 mg,32 mg). Following
this trial, the Company expects to discuss with The U.S. Food and Drug Administration (“FDA”) its planned Phase III
trial.
Patients randomized
in the trial treated with 8 mg of ORMD-0801 once-daily achieved an observed mean reduction of 1.29% from baseline and a least square
mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo (p value = 0.028). Patients who had A1C readings above 9%
at baseline and received 8 mg of oral insulin once-daily experienced a 1.26% reduction in A1C by week 12.
Treatment with ORMD-0801
at all doses demonstrated an excellent safety profile, with no serious drug-related adverse events and with no increased frequency
of hypoglycemic episodes or weight gain compared to placebo.
The primary efficacy
endpoint was a reduction in Hemoglobin A1C (A1C, also known as HbA1C, a key clinical measure of blood glucose control) at week
12.
In the second cohort,
78 U.S.-based patients were enrolled, treated, and randomized into five groups: 8 mg dosed once-daily; 8 mg dosed twice-daily;
16 mg dosed once-daily; 16 mg dosed twice-daily; and placebo dosed once-daily. The same two sites which were excluded from the
statistical analysis in the primary cohort due to evidence of treatment-by-center interaction and a statistically significant placebo
effect, were excluded in the second cohort, representing a patient population of 13 patients. Of the 65 patients included in the
analysis, 57 completed through week 12.
The once-daily and
twice-daily arms of patients dosed at 8 mg achieved statistically significant (p-value 0.028 and 0.029, respectively) reductions
from baseline in A1C of 0.95% (0.81% with placebo adjustment) and 0.95% (0.82% with placebo adjustment), respectively. Patients
dosed once-daily at 16 mg and twice-daily at 16 mg did not show statistically significant reductions in A1C.
Forward-looking Statements
This Current Report on Form 8-K contains forward-looking statements.
For example, the Company is using forward-looking statements when it discusses the potential of ORMD-0801 to be the first commercial
oral insulin capsule for the treatment of diabetes, the safety and efficacy of ORMD-0801, the ability of ORMD-0801 to reduce HbA1C,
the timing of expected clinical development programs and discussions with the FDA. In addition, historic results of scientific
research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even
similar conclusions. These forward-looking statements are based on the current expectations of the management of the Company only,
and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described
in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of
clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection
for its product candidates; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional
funding required to conduct its research, development and commercialization activities. In addition, the following factors, among
others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology
and market requirements; delays or obstacles in launching its clinical trials; changes in legislation; inability to timely develop
and introduce new technologies, products and applications; lack of validation of its technology as the Company progress further
and lack of acceptance of its methods by the scientific community; inability to retain or attract key employees whose knowledge
is essential to the development of its products; unforeseen scientific difficulties that may develop with its process; greater
cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results
that do not translate to equally good results in real settings; its patents may not be sufficient; and finally that products may
harm recipients, all of which could cause the actual results or performance of the Company to differ materially from those contemplated
in such forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release
any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence
of unanticipated events. For a more detailed description of the risks and uncertainties affecting the Company, reference is made
to the Company’s reports filed from time to time with the U.S. Securities and Exchange Commission.