Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) , a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today provided a clinical update regarding four ongoing clinical programs.
“All of our clinical programs continue to advance on-track as planned with no related serious adverse safety issues. We expect to provide meaningful clinical results from these ongoing trials in the coming months,” stated Oramed CEO, Nadav Kidron. “We believe we have a unique oral technology platform that has the potential to revolutionize the effective delivery of important medication to improve the treatment of diabetes and related conditions.”
Oramed Also Announces that Xiaoming Gao Joins Board of Directors
Mr. Gao is the Chairman of Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”), which signed a strategic licensing partnership with Oramed in November 2015 to bring oral insulin to China. HTIT received an IND from the Chinese regulatory authorities to initiate oral insulin clinical trials in China. Mr. Xiaoming Gao has more than 30 years of experience in the insulin industry and launched Novo Nordisk insulin to most of China and then was in charge of its distribution for the following 11 years.
Oral Insulin: In mid-May, Oramed completed enrollment and randomization of close to 300 patients in the primary cohort for its 90-day dose-ranging Phase IIb HbA1c clinical study of its oral insulin capsule, ORMD-0801, for Type 2 diabetes.
Over 80% (237 patients) of these patients have completed treatment in the study.
The Phase IIb double-blind, randomized study for Type 2 diabetes is designed to identify the optimal dose to take into Phase III evaluation. The Phase IIb study will assess the primary efficacy endpoint of reduction in HbA1c as well as safety endpoints. Study results for the primary cohort are expected by year-end 2019. Following the results of the primary cohort Oramed plans to initiate an end of Phase II meeting with the FDA to discuss Phase III protocol.
In addition, Oramed initiated a secondary cohort of patients within the 90-day Phase IIb HbA1C clinical study to evaluate potential efficacy of ORMD-0801 at lower doses. The results are expected in 1Q 2020.
GLP-1
Oramed completed its Phase I pharmacokinetic (PK) study for ORMD-0901, its oral glucagon-like peptide-1 (GLP-1) analog of exenatide capsule for Type 2 diabetes. This is the first study of ORMD-0901 under Oramed’s existing FDA Investigational New Drug application (IND). It is a randomized, single-blind, placebo-controlled, crossover study that aims to evaluate the safety, in addition to the pharmacokinetics, of ORMD-0901 compared to placebo and to open-label subcutaneous exenatide (an FDA-approved GLP-1 analog currently on the market) in 16 healthy subjects. Oramed is now assessing the results for future study options. Previous small studies have shown positive trends.
NASH
Oramed is conducting an exploratory clinical trial with ORMD-0801 for the treatment of nonalcoholic steatohepatitis (NASH). Prevalence of NASH is accelerating rapidly and correlates directly with the rising incidence of Type 2 diabetes. The exploratory 3-month NASH study is ongoing, and Oramed expects to conclude the first cohort by 4Q 2019.
Oral Leptin
Oramed is conducting an exploratory trial with an oral leptin capsule to evaluate glucagon reduction in Type 1 diabetes, with a long-term goal of addressing weight loss. Leptin, known as the “obesity hormone,” is a protein that regulates hunger. Obesity and diabetes are highly correlated.
Oramed’s proof-of-concept, single-dose study examining glucagon reduction, the first in humans, is planned to begin in 3Q 2019. The study will enroll 10 patients with Type 1 diabetes.
Study results are expected in 4Q 2019.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology that is based on more than 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize 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 Type 2 and Type 1 diabetes. The Company has completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901, which has potential to be the first orally-ingestible GLP-1 analog.
