There’s no shortage of innovative approaches to helping people lose weight today, whether it’s filling space in the stomach to create an artificial sense of fullness, using neuromodulation to keep hunger at bay, or using online or mobile tracking tools. But this company is taking a different approach, aiming at the biological underpinnings of obesity with a drug that it thinks can restore balance to how the body stores and metabolizes fat in severely obese individuals.
Cambridge, Massachusetts-based Zafgen Inc.’s lead product is beloranib, and it’s headed to phase 2 with a trial expected to start within the next two weeks, according to CEO Thomas Hughes. It will study the effectiveness of the drug in about 150 men and women over time.
In a phase 1 trial that lasted 25 days, the drug delivered “robust data” showing “impressive improvements” in severely obese women, Hughes said. Beloranib was associated with weight loss and improvements in triglycerides, LDL cholesterol, waist circumference and diastolic blood pressure (PDF). This study will test whether those effects are sustained over time.
Belanorib takes aim at the biological and metabolic changes in the way fat is stored and released in obese individuals. It was developed to inhibit the enzyme methionine aminopeptidase 2 to reduce the liver’s production of new fatty acid molecules and help convert stored fats into energy.
Hughes said the $3 million in debt financing recently disclosed in a U.S. Securities and Exchange Commission filing was another installment of a $33 million C round from Atlas Ventures and Third Rock Ventures announced in July 2011 that will help the company get through the trial. In total, Zafgen has raised about $60 million, he said.
It’s a little early to speak about Zafgen’s go-to-market strategy, Hughes said, but the 20-year Novartis AG veteran indicated that he’s been heartened by the U.S. Food and Drug Administration’s approval of Belviq and Qsymia earlier this summer after more than a decade of no new weight loss drug approvals.
That’s something numerous other drug developers and a growing number of medical device makers have taken note of as well. Currently, the $1.2 billion market for obesity treatment drugs and devices is growing at a double-digit rate, according to MedMarket Diligence.
“This is really encouraging,” Hughes said. “It’s showing us that not only is there an opportunity for treatment of obesity, but there is an open acknowledgement that obesity is a chronic disease.”