ORMP: ORMD-0801 in Phase 3 TD2 and NASH Clinical Studies
By M. Marin
NASDAQ:ORMP
READ THE FULL ORMP RESEARCH REPORT
Oramed Pharmaceuticals Inc. (NASDAQ:ORMP), a clinical-stage pharmaceutical company with a proprietary oral protein delivery platform technology, has screened the first patients in its global TD2 Phase 3 trials and its global NASH trial for its proprietary oral insulin capsule, ORMD-0801, the company's lead development candidate.
The company believes that ORMD-0801 could become the first commercial oral insulin capsule for the treatment of diabetes, a disease that is growing in prevalence and which puts the patient at increased risk for blindness and heart attack, among other diseases, and which results in significantly higher per patient (2.3x) healthcare costs and an aggregate estimated national annual cost of $327 billion.
NASH Trial Also Moving Forward
Oramed also has screened the first patients in its global NASH trial in which ORMD-0801 is being studied for the treatment of patients with nonalcoholic steatohepatitis (NASH). The number of NASH cases is expected to increase by as much as 63% from 2015 to 2030, according to National Institute of Health (NIH), driven by rising obesity rates, unmet medical needs and sedentary lifestyles, among other factors. Estimates of the global NASH drug treatment market range from about $20 billion to higher by the mid-2020's.
Based on the strong results from a previous study, where ORMD-0801 showed a 30% relative reduction in liver fat, the company appropriately felt it would be valuable to move clinical trials forward. The earlier study of the first eight patients in the Oramed NASH trial showed that the 12-week, once-daily treatment had no serious adverse events, and induced an observed mean 6.9±6.8% reduction in liver fat content. The relative reduction, as measured by MRI-PDFF, was 30%. The data suggests that ORMD-0801 can have a positive effect in people with type 2 diabetes.
Additional Applications
In addition to ORMD-0801, ORMP is also studying the underlying technology for an orally ingestible GLP-1 capsule, ORMD-0901. Moreover, given the potential versatility of the company’s oral protein delivery platform technology, ORMP believes that the platform could also be effective for protein-based vaccines for the COVID-19 virus caused by SARS-CoV-2 novel coronavirus and is monitoring developments for the possibility of forming potential partnerships with regard to a COVID-19 vaccine. With many markets heading into second rounds of lockdowns, there is still a tremendous global need for a COVID-19 vaccine.
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