- Topline Pivotal Phase 3 Oral Insulin Data Expected
- Phase 2 NASH Trial Achieved Primary and Secondary Endpoints
- Definitive Deal Signed to Commercialize Oral Insulin in
South Korea $160 Millionin Cash and Investments (as of September 30, 2022)
Dear Shareholders and wider investor community,
The year 2022 was a very strong year for Oramed. The first of our two Phase 3 oral insulin trials, ORA-D-013-1, completed enrollment with a wider scope of patients than originally planned, and we expect to announce topline results in
Phase 3 Oral Insulin Trials: Top-Line Data Expected
ORA-D-013-1, the first of our two pivotal Phase 3 oral insulin trials for ORMD-0801 in the treatment of type 2 diabetes met and exceeded the number of planned participants, with 710 people enrolled. We expect to announce topline results in the next four weeks. ORA-D-013-2, our concurrent Phase 3 trial, continues to enroll the planned 450 patients, with enrollment expected to be completed in 2023.
Phase 2 NASH Trial Achieved Primary Endpoints
Our Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial assessing the safety and efficacy of ORMD-0801 in the treatment of non-alcoholic steatohepatitis (“NASH”) in 32 patients with Type 2 diabetes and NASH achieved its primary endpoint of safety and tolerability, demonstrating consistent trends across key secondary endpoints with reduction of liver fat, liver stiffness and lipids. We believe ORMD-0801 may be an ideal treatment option for the millions of people living with both diabetes and NASH. We held a Key Opinion Leader webinar in November discussing the positive data and exciting potential of Oramed’s oral insulin candidate as a treatment option for this indication. The full webinar can be viewed on the Oramed website. There is currently no FDA approved treatment for NASH, which is expected to become an
Definitive Deal with Medicox to Commercialize Oral Insulin in
Continuing to build global partnerships, we signed an exclusive commercial distribution agreement for
Phase 1 Oral COVID-19 Vaccine Trial Reported Positive Preliminary Data
Our subsidiary Oravax’s first cohort in its Phase 1 clinical trial of our oral virus-like particle (VLP) COVID-19 vaccine for COVID-naive participants achieved its primary and secondary endpoints of safety and immunogenicity based on preliminary data. Our oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline. We believe this trial shows proof of concept for oral delivery of vaccines using Oravax’s technology. Complete Phase 1 results are expected in the first quarter of 2023.
Oral GLP-1 Bioavailability Trial
ORMD-0901, our oral glucagon-like peptide-1 (GLP-1) analog capsule, is currently being evaluated under an FDA Investigational New Drug (IND) application and we expect to issue an update regarding the trial’s progress in the coming weeks. GLP-1 is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently available in injectable form only. An oral GLP-1 could significantly increase compliance and become a valuable tool in the treatment of diabetes.
We are entering 2023 with real excitement for what we believe will be a monumental year for the Company. We thank you, our shareholders, for your support and we thank our partners and trial volunteers for helping advance our clinical and other efforts. We wish you all a happy and healthy new year and look forward to keeping all our shareholders updated on news and developments.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes, the expected release of top-line data for ORA-D-013-1, the potential safety and efficacy of ORMD-0801 to treat diabetes and NASH, the expected market for drugs to treat NASH, the potential of ORMD-0801 to be a well-tolerated and convenient oral insulin product for the treatment of patients with diabetes and NASH, the potential development of an oral COVID-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, immunogenicity and other advantages of the vaccine against current and future coronavirus strains or for the broader vaccines market, the potential for regulatory approval or development of ORMD-0801 in
Logo – https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/oramed-letter-to-shareholders-301708155.html