Oramed Phase 2 Oral Insulin NASH Trial Reaches Over 50% Enrollment

Oramed Pharmaceuticals Inc., a Jerusalem-based clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, has enrolled over 50% of patients planned for its Phase 2 trial of its oral insulin capsule, ORMD-0801, for the treatment of non-alcoholic steatohepatitis (NASH). Patients continue to be screened at sites in the U.S. and Israel.

Forbes published an article about Oramed’s Oral Insulin approaching market entry:
https://www.forbes.com/sites/carrierubinstein/2020/02/27/diabetic-patients-get-ready-an-oral-insulin-capsule-that-may-soon-be-on-the-market/?sh=34b597743704

The double-blind multi-center trial is assessing the safety and potential efficacy of ORMD-0801 in type 2 diabetes patients with NASH. Efficacy endpoints including percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline will be measured via MRI-PDFF following 12 weeks of dosing.

“With more than half of NASH patients having diabetes, ORMD-0801 has the potential to improve outcomes for patients in both conditions. NASH is a disease with a significant unmet medical need, as no drugs are currently approved to treat this condition, which is a leading cause of liver transplants in the U.S. We are excited to build upon our pilot study’s results which showed a reduction of liver fat content to demonstrate the potential for ORMD-0801 to help patients living with NASH,” said Oramed Chief Executive Officer, Nadav Kidron.

The global market for drugs to treat NASH is expected to reach $84 billion by 2029.

Oramed is also developing an oral vaccination for COVID by partnered with the Indian company, Premas Biotech. The oral Covid vaccination which is a single pill is undergoing clinical trials. At a recent Brazil-Israel Chamber of Commerce event, Oramed CEO, Nadav Kidron, and Premas Biotech CEO, Prabuddah Kundu dive into the details of Oramed’s oral platform technology currently being used to develop an oral insulin pill and the Oravax Medical oral Covid-19 vaccine, which can be seen at https://www.youtube.com/watch?v=hu-9fzBsKzM

About NASH

Non-alcoholic steatohepatitis (NASH) is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few management options.

About Oramed Pharmaceuticals Inc.

Oramed Pharmaceuticals Inc. (Nasdaq/TASE:ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006 with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (PODTM) technology that is based on more than 30 years of research by scientists at Jerusalem’s Hadassah Medical Center.

Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes.

Since insulin was first discovered, it has been impossible to deliver it orally, because of degradation and factors affecting absorbance; since insulin is a protein, the body breaks it down when ingested. The company uses enteric coating and special protection which allows the insulin to stay intact through the GI tract and reach the intestinal wall. Via special absorption enhancers, the insulin can pass through this wall and into the liver, where it starts working. Importantly, it mimics the natural path of insulin in the body, by heading to the liver first.

Oramed has completed multiple Phase 2 clinical trials for patients with diabetes under an Investigational New Drug (IND) application with the U.S. Food and Drug Administration. Treatment with the capsule at all doses demonstrated an excellent safety profile, with no serious drug related adverse events and no increased frequency of hypoglycemic episodes or weight gain, compared to the placebo.

“The statistically significant efficacy data,” said Joel M. Neutel, MD, Principal Investigator of the Phase 2b trial, “coupled with a clean safety profile characterized by no reported weight gain, no increase in serious drug-related adverse events, and no hypoglycemia, further support its clinical potential. It further validates the clinical potential of oral insulin to have a highly beneficial impact on the treatment of diabetes worldwide.”

Oramed CEO, Nadav Kidron, is confident that the costs of the ORMD-0801 pill will be significantly lower (by tens of percent) than the cost of insulin injections.

For further information, http://www.oramed.com

Company Contact:
Josh Hexter tel: 1-844-9-ORAMED
email:  josh AT oramed.com

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