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ORMP: Advancing Toward Phase 3 Program For ORMD-0801


By M. Marin



Oramed Pharmaceuticals Inc. (NASDAQ:ORMP), a clinical-stage pharmaceutical company with a proprietary oral protein delivery platform technology, is getting ready to initiate two Phase 3 clinical trials after the FDA has reviewed its Phase 3 protocols and nonclinical documents. This follows positive feedback from the FDA during its end of Phase 2 meeting.

Earlier this month, Oramed updated clinical research organization services agreements with Integrium for the planned upcoming Phase 3 clinical trial to be conducted under an FDA Investigational New Drug (IND) application.

Oramed’s Phase 3 trial is designed to assess the safety of ORMD-0801 and evaluate its efficacy on about 675 patients with type 2 diabetes. Oramed plans to conduct two concurrent phase 3 trials in a double-blinded, placebo-controlled, double dummy, multi-center randomized, Phase 3 study.

We believe demand for ORMD-0801 within the medical community and among patient populations could be significant, given that ORMD-0801 is a less invasive oral treatment option that potentially does not cause hypoglycemia or weight gain.

In fact, findings from a recent study that Oramed commissioned from a third-party research firm shows strong potential support from health care providers for the use of oral insulin with T2D patients early in the treatment process through a primary care physician before the need for injectable insulin arises and before the patient must be seen by an endocrinologist for diabetes care. Health care providers saw the advantages of ORMD-0801’s potential to not cause hypoglycemia or weight gain and as an oral medication that could avert the need for injections.

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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