Approximately 200 patients will be included in the Phase III study in order to achieve regulatory approval in Pakistan
WEST CALDWELL, NJ and TORONTO, ON, June 26, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- EastGate Biotech Corp. (OTC: PINK: ETBI), a pharmaceutical company that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of Type 2 diabetes, announced today that it has filed an application with the Drug Regulatory Authority of Pakistan (DRAP) and Ministry of National Health Services to initiate a Phase III clinical study for Insugin. EastGate recently completed a positive Phase II clinical trial of its innovative liquid insulin mouth rinse solution, Insugin, for Type 2 diabetes patients. The Phase III trial design is consistent with the 90-day Phase II study that recently met its endpoints.
The application requests the dosing of 200 Type 2 diabetic patients in order to achieve statistically significant results for regulatory approval of Insugin in Pakistan. EastGate is considering dosing as many as 500 patients for inclusion in the Phase III clinical study. The larger patient population gives the Company greater flexibility in dealing with submissions to surrounding territories for regulatory and marketing purposes.
EastGate completed its Phase II clinical trial in Pakistan in May and met its primary endpoints of demonstrating the safety and efficacy of Insugin. The Phase II study was designed to assess the safety, tolerability, pharmacokinetics and efficacy against a placebo arm. There were no Severe Adverse Events (SAE’s) and the drug was well tolerated. The HbA1c levels decreased by 0.39% after only 1 week of treatment in combination with Metformin versus placebo. The patients enrolled in the study were Type 2 diabetes patients currently on Metformin treatment who took a regiment of 25 IU of Insugin, a recombinant human liquid insulin mouth rinse twice a day at mealtime along with 500 mg of Metformin.
The study summary and conclusions included:
-Insugin offers unique benefits and the product’s goal is to slow down progression of Type 2 diabetes mellitus and reduce complications;
-Insugin displayed a good safety and tolerability profile;
-Observed a statistically significant decrease in A1c levels after 1 week of treatment in combination with Metformin versus placebo;
-Observed that the most significant HbA1c reduction resulted from administration of a single dose of Insugin (25 IU) two times a day;
-Observed improvements in insulin secretion in Type 2 diabetes patients during hyperglycemic clamp;
-Observed that clinical efficacy of Insugin was non-inferior to Metformin, while its effect on HOMA-IR and fasting insulin level was superior compared to Metformin;
-Prevents the first step of apoptotic cascade (cytochrome C release) and protects cells from dying when submitted to an oxidative stress level (high glucose levels);
-Prevents endothelial dysfunction, which is well correlated to an improvement of atherosclerosis and cardiovascular complications;
-Preserves beta cell mass and beta cell function over time, leading to a potential delay of the disease’s progression;
“We look forward to receiving a positive response from the Drug Regulatory Authority of Pakistan (DRAP) in order to proceed with the Phase III clinical study of Insugin,” said Anna Gluskin, CEO of EastGate Biotech. “We have been pleased to have collaborated with Genome Pharma/Origin Pharma who were as committed to the progression of our liquid insulin mouth rinse for Type 2 diabetes patients. The diabetes numbers speak for themselves. The rate of diabetes around the world is increasing at a break speed rate. There is a real need for a non-injectable formulation of insulin that will encourage greater patient compliance, and ultimately leads to better maintenance of glucose control. I cannot emphasize this enough, but our liquid insulin mouth rinse may have the ability to maintain better glucose control among Type 2 patients which will slow down the progression of the disease and reduce the incidence of debilitating conditions such as strokes, heart attacks, kidney disease,” concluded Anna Gluskin.
“We look forward to the next step of our development plan with Insugin,” stated Nasir Irfat, Director of Genome Pharma/Origin Pharma, EastGate’s Joint Venture partner. “The patients in the Phase II trial were very pleased with their results and found the product easy to administer and expressed an overall satisfaction with Insugin. As we move forward with the Phase III study and eventually commercialization in Pakistan and the surrounding countries, we hope to demonstrate consistency in our data,” Nasir Irfat continued.
About EastGate Biotech
EastGate Biotech focuses on innovative technological developments and produces and distributes innovative drug compounds and healthy nutraceuticals that are based on natural therapies absorbed by the body. We utilize advanced nanotechnologies and alternative delivery systems that take difficult to deliver compounds and deliver them using our nanotechnology platform which ultimately increase the bioavailability to the body. Using our methods of delivery provides healthy alternatives to conventional pharmaceuticals that all-too-often create dangerous side-effects and unexpected consequences for those trying to attain and maintain a healthy lifestyle. EastGate's wholly owned subsidiary Omni Surgery and Anti-Aging Centre is the first of many surgery centers to come under the Omni umbrella as we plan to roll up existing business under the Omni brand and expand our footprint globally.
Cautionary statement on forward-looking information
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