Zafgen Inc., a closely held developer of an experimental drug for obesity, said its therapy yielded weight loss of as much as 10 kilograms (22 pounds) in three months, an early look at study results showed.
Patients taking the drug, called beloranib, also showed lower levels of triglycerides and low-density lipoprotein, or LDL, cholesterol, and felt less hunger after 12 weeks, the Cambridge, Massachusetts-based company said today in a statement. The data on the first 19 patients to complete the 148-person study were presented today at the American Diabetes Association meeting in Chicago.
Zafgen’s drug, in the second trial phase of three generally required for regulatory approval, works differently from obesity therapies that have recently entered the market from Vivus Inc. and Arena Pharmaceuticals Inc., which aim to control appetite through the brain. Beloranib targets an enzyme, MetAP2, that regulates fatty acids. By inhibiting MetAP2, the drug helps to convert stored fats into energy.
“Our hope is beloranib will have the ability to eliminate all excess weight in people,” Zafgen Chief Executive Officer Tom Hughes said in a telephone interview. “These remain to be early data, but still we’re pretty pleased with what we’re seeing overall.”
The drug is designed to be given twice weekly by injection for severe obesity, and Zafgen aims to treat patients who may otherwise consider bariatric surgery, Hughes said.
In the interim results presented today, patients on 2.4 milligrams of beloranib had average weight loss of 9.9 kilograms over 12 weeks. Those on 1.2 milligrams lost an average 6.1 kilograms, while those on 0.6 milligram lost an average 3.8 kilograms. Patients on placebo, on average, gained 1.8 kilograms.
Patients were allowed to eat normally and weren’t guided to change their exercise habits. The drugs on the market from Vivus and Arena, called Qsymia and Belviq, are approved for weight loss on top of a lower-calorie diet and exercise plan.
“We’re still trying to isolate the drug effect,” Hughes said.
Side effects associated with the drug were trouble falling asleep, nausea and vomiting. There were no serious adverse events.
Zafgen is planning to raise money later this year and may consider an initial public offering in 2014, Hughes said.
“Based on the data we’ve generated and our cash position, which is quite good right now, we’re working from a position of strength,” Hughes said. The company has enough cash on hand to carry out its current plans, and will raise more to fund larger studies. “We’re just trying to essentially maximize the value of the program and to keep moving as efficiently as we can in the meantime.”
Full data from the study are expected before October.