Zafgen, a biopharmaceutical company reported a statistically significant result for their lead candidate drug, Beloranib, in treating obesity complicated Type-2 diabetes. The company is known for developing drugs that helps improve the lives of patients suffering from obesity and other complex metabolic disorders like diabetes.
In the ZAF 203 clinical trial, Beloranib shows a positive result for improving body weight, glycemic control and body composition. Beloranib is a MetAP2 inhibitor that targets patients with severe obesity that is complicated by type-2 diabetes. The data is presented at the 76th Scientific Sessions of the American Diabetes Association.
The company reported that beloranib is associated with improvement in the patient’s body composition including a significant reduction in fat mass, body weight, waist and hip circumference and liver fat. The drug also help improve various glycemic control parameters including insulin sensitivity, beta-cell function, post-prandial glucose, fasting plasma glucose and HbA1c as compared with the placebo.
The company noted that ZAF-203 experimental trial is able to achieve its primary endpoint in terms of drug efficacy. Beloranib showed statistically significant reduction in the patient’s body weight compared with placebo.
The patients enrolled in 1.2 mg and 1.8 mg treatment also met the secondary efficacy endpoint. Patients in both doses achieve an absolute reduction of HbA1c after six months of treatment. The patients in the control group have 2 percent reduction as compared with 0.6 percent in the placebo.
Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen said in a statement that the results reinforce the MetAP2 inhibition as potential for treating various metabolic disorders that are linked with obesity. The study may also point a potential improvement in insulin sensitivity and pancreatic function that will improve glycemic control. The data also adds consistent and compelling efficacy data for beloranib clinical trials. The results may also offer a greater perspective on the drugs benefit-risk profile.
The Efficacy and Safety Result of ZAF-203
In the Zafgen’s Clinical Trial, 152 patients participated in the randomized study. Patients receive twice a week subcutaneous injection of either 1.2 mg or 1.8 mg of beloranib or placebo drug, in addition to exercise and diet regimen. Sixty-six patients comply the pre-specified primary analysis population. They complete the treatment schedule of six months in compliance with the protocol set by FDA. Last October 2015, FDA issued a partial clinical hold on beloranib because the company was asked to comply first with the protocol for dosing suspension.
Improve Well-being of Obese Patients with Type 2 Diabetes
The ZAF-203 clinical trial aims to improve the life and well-being of patients with severe obesity and type-2 diabetes. Beloranib shows statistically significant results which increases its potential for approval. If granted an approval by FDA, the drug will be beneficial for obese individuals with complex metabolic disorders like diabetes.
The approval of this drug will help millions of individuals considering that obesity and diabetes are one of the most common health epidemics in the world today. According to World Health Organization, 2.8 million people die of obesity and other obesity-complicated diseases every year. It is estimated that 35.8 million worldwide is suffering from obesity or overweight issues.