The Marketing Application Approval in Pakistan will follow subject to completion of the Phase III clinical study that will include up to 200 Type 2 patients.
WEST CALDWELL, NJ and TORONTO, ON /NEWMEDIAWIRE/ September 25, 2019/ 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 received regulatory approval of its application for Insugin, the company’s liquid insulin mouth rinse solution, with the Drug Regulatory Authority of Pakistan (DRAP), Ministry of National Health Services, Regulations A Coordination, Islamabad (www.dra.gov.pk). The Directorate of Biological Drugs and Pharmacy Services Department of DRAP approved the application for registration of Insugin, Clinical Observation, and Evaluation in Process Studies. The regulatory authority requested the completion of a Phase III clinical study prior to granting marketing approval of Insugin in Pakistan.
The Phase III clinical study will include up to 200 Type 2 diabetic patients which should provide statistically significant results. The Phase III clinical study will be a 90-day study and the study design would be consistent with the Phase II Clinical Study protocol that was conducted in Pakistan earlier this year.
Insugin met its primary endpoint in the Phase II study which was designed to demonstrate the safety and efficacy of Insugin. As previously reported, the company enrolled Type 2 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 Phase II study assessed safety, tolerability, pharmacokinetics and efficacy. A placebo arm was also incorporated in the clinical protocol.
The study summary and conclusions included:
-Insugin offers unique benefits and the product’s goal is to slow down the 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 the 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 the 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 are thrilled by this positive response from the Drug Regulatory Authority of Pakistan (DRAP) and its direction to fast-track the progression of Phase III clinical study of Insugin and ultimately marketing approval in Pakistan that will parley into approvals in other regional countries”, says Anna Gluskin, CEO of EastGate Biotech. “This year alone, we have vaulted development from initiating a Phase 2 study to a Phase 3 ready drug. Very few drugs have ever seen this level of regulatory fervor. With a clear path forward we are quickly mobilizing to initiate the Phase III study. We are pleased with the commitment from our local partner who recognized the real need for non-injectable formulation of insulin that will encourage greater patient compliance, and ultimately leads to better maintenance of glucose control. Our common goal is to improve the long term outcomes for Type 2 diabetes patients and reduce the incidence of debilitating conditions such as strokes, heart attacks, kidney disease.”
“We are ecstatic about demonstrating the effectiveness of our innovative product in Pakistan, which is widely expected to be the first country to commercialize our drug,” said Rose C. Perri, President of EastGate Biotech. “Pakistan will serve as a base case model by which EastGate Biotech will be able to extrapolate essential metrics such as the size of the market and the penetration rates. This data will aid in the strategic rollout of the surrounding markets in the coming year. Since there is synergistic reciprocity in the region amongst the regulatory agencies, our focus will be on harmonizing the registration statement while we are completing our 90-day Phase III study and the eventual product approval and launch in Pakistan.”
“Our blistering pace of development couldn’t have been accomplished without the hard work and dedication of EastGates development team, which has put in years of planning to get to this stage” stated Bill Abajian, Chief Operating Officer of EastGate Biotech. “Moving at a record pace has its advantages because potential licensing partners are keenly aware that if they don’t stay on top of corporate developments multinational pharmaceutical companies could be shut out of the market. As I have stated earlier, we are on the cusp of major licensing initiatives and believe this announcement might be the tipping point. We have changed the paradigm of how small biotech brings drugs to market and our development trajectory is one of the tools that will captivate a potential licensors attention. A condensed development timeline has a tendency to facilitate partnering or acquisition discussions as the parties involved realize they no longer have the luxury of time. Our fundamental story had taken a huge leap forward and I hope investors realize we are quite serious about increasing shareholder value and will continue to deliver in the near future through transparency and communications.”
“Until the insulin pricing scandal, many new diabetes drugs were introduced into the market, that had long term detrimental side effects in exchange for a rather dubious benefit. Insugin is a human insulin product that combines innovation and simplicity all in one. It is a patient-friendly, easy-to-administer, safe product that has already demonstrated effective glucose management in the stellar Phase II clinical studies. There is no device that is required or intensive prior screening or lengthy training for the patients. The Phase III protocol will be consistent with the Phase II study design but with a larger patient pool. We look forward to demonstrating to shareholders and future partnerships alike the true value of Insugin” concluded Bill Abajian.
“We look forward to testing more Type 2 diabetes patients with Insugin and widening the use of the product within our market”, stated Nasir Irfat, EastGate’s Joint Venture partner in Pakistan. “We hope that the initial satisfaction that the patients that participated in the Phase II study experienced will continue as we proceed and complete the Phase III study. We hope that demonstrating consistent results will allow us to fast track the marketing approval in Pakistan.”
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 increases 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.
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