EastGate Biotech Corp. announced 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. 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 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.