Zafgen raised eyebrows two years ago when it showed that its injectable drug, which changes the way the body metabolizes fat, helped severely obese people in a small clinical trial lose a lot of weight in the span of a month. Today, the Cambridge, MA-based company is giving a sneak peek into its next study—and, while it’s a tiny sample size, the numbers appear to be holding up.
Cambridge, MA-based Zafgen today is releasing interim results at the 73rd American Diabetes Association Scientific Sessions from a 12-week mid-stage clinical trial testing the drug, named beloranib, in 160 severely obese patients—those with an average body mass index, or BMI, of 38. The results provide just a glimpse of the data. They account for just the first 19 patients out of the study, all female, of which only 14 were dosed with the drug rather than a placebo, according to Zafgen president and CEO Tom Hughes. But even so, they continued to show beloranib’s potential fat-zapping ability.
The five patients given the smallest dose of beloranib (0.6 milligrams) lost about 8.4 pounds over the course of 12 weeks, translating to 5.5 percent increase in total loss of body weight over placebo. The six patients on a 1.2 mg dose lost an average of 13.4 pounds, for a 7.7 percent body weight loss over placebo. And the three patients on the highest (2.4 mg) dose lost an average of 21.8 pounds, or 12.2 percent over placebo, according to Hughes.
“Let’s just say we’re quite pleased with that,” he says.
Zafgen was initially formed in 2008 to build off of research from the Boston Children’s Hospital which found that drugs that stopped blood vessels from forming might also help shrink fat tissue. That hypothesis turned out to be wrong, but the small-molecule drug Zafgen tested, now known as beloranib, worked in animal studies anyway—just for an entirely different reason. It changed the way the body metabolized fat.
Specifically, beloranib reduces the over-production of fat in the liver that occurs in severely obese people by inhibiting the production of an enzyme called methionine aminopeptidase 2, or MetAP2. That, in turn, causes the body to release the fat and turn it into a source of fuel. The drug is being developed as an injection just under the skin that would be administered twice a week through a small syringe under the supervision of a doctor. This method is completely different than many of the other appetite-suppressing obesity drugs, which fool the body into thinking that it is full.
Beloranib, as it showed in an earlier clinical trial, also continues to improve peoples’ levels of cardiovascular risk markers such as triglycerides, low-density lipoprotein (LDL) cholesterol, and C-reactive proteins (CRP).
Here’s how the latest study worked. Zafgen enrolled people of an average age of … Next Page »