Zafgen Inc. (ZFGN), after going through setbacks last year including patient deaths, has something to cheer on. The obesity-focused biopharmaceutical company's trial for Beloranib, intended to treat severe obesity complicated by type 2 diabetes, showed statistically and clinically significant improvements in body weight, body composition, and glycemic control.
The drug is on hold with the Food and Drug Administration, partially since October 2015, and fully since December last year, until the company can address risk of blood clots in patients.
The company noted that the ZAF-203 clinical trial evaluating beloranib, a MetAP2 inhibitor, achieved its primary efficacy endpoint, and the data showed that the drug was associated with improvement in body composition, including a significant decrease in body weight, fat mass, reduction in waist and hip circumference, and improvements in liver fat.
It also showed improvements in glycemic control parameters including HbA1c, fasting plasma glucose, post-prandial glucose, beta-cell function, and insulin sensitivity, when compared to placebo.
The positive study results were presented over the weekend during the American Diabetes Association's 76th Scientific Sessions.
Patients enrolled in both the 1.8 mg and 1.2 mg treatment arms also met a key secondary endpoint, with patients in each dose arm achieving an absolute reduction in HbA1c following six months of treatment.
Thomas Hughes, chief executive officer of Zafgen, said, "These results reinforce the potential of MetAP2 inhibition as an approach to treating metabolic disorders associated with obesity, and point to potential improvements in both pancreatic function and insulin sensitivity as contributors to improved glycemic control."
"Additionally, these data add to the compelling and consistent efficacy data that have emerged across our beloranib clinical trials, while offering greater perspective on its benefit-risk profile," he added.
In a research note Monday, RBC Capital Markets analyst Simos Simeonidis rated the company outperform, stating that the data was very impressive.
In September last year, the news of two patient deaths forced the company's stock price to plunge, and since then has been struggling to find a base.
Zafgen shares improved around 6 percent in the morning trading, but settled on Monday at $6.10, down 4.54 percent. In the extended trading, stock moved up by 1.64 percent.
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