Zafgen drug helps patients lose up to 24 pounds
November 15, 2013 7:01 AM ET
Nov 15 (Reuters) - An experimental obesity drug, which unlike other therapies targets the body and not the mind, helped patients lose up to 24 pounds (11 kg), or about 11 percent of their body weight, in a clinical trial, its developer said on Friday.
The injectable drug, beloranib, made by privately held Zafgen Inc, also improved patients' good cholesterol levels and lowered their blood pressure. It was also found to be safe in the mid-stage trial.
Obesity treatments have a checkered past, and several drugs have been withdrawn from the market due to severe safety issues.
Many of the safety concerns relate to how most of these drugs work by suppressing appetite, requiring them to tinker with signals telling the brain that the stomach is full.
Two obesity drugs that won approval mid-2012, Vivus Inc's Qsymia and Arena Pharmaceuticals Inc's Belviq, have also shown serious side effects, ranging from depression and anxiety to heart risks and potential harm to fetuses.
Both Qsymia and Belviq involve signaling the brain, though the exact way they work is unknown.
Beloranib, on the other hand, is designed to make the body produce less fat and burn off the excess as fuel. The drug works by blocking an enzyme known as methionine aminopeptidase 2, or MetAP2, which plays a key role in the production and use of fatty acids.
Final data from the trial that tested the drug in 147 obese patients showed that those taking the highest dose lost about 24 pounds (11 kg) after 12 weeks of treatment, compared to a 0.9 pound (0.4 kg) weight loss seen by those on placebo.
"We are planning a phase 2b trial, which we currently anticipate to start later in the first half of 2014," Zafgen Chief Executive Thomas Hughes told Reuters.
The company plans to discuss the trial design with the U.S. Food and Drug Administration next year.
Vivus's Qsymia had helped patients lose about 30 pounds and 37 pounds on average after 56 weeks of treatment in two separate late-stage trials. Patients on Belviq had lost an average of about 17 pounds after 52 weeks of treatment.
Zafgen said there were no serious adverse events deemed to be related to beloranib in the trial and no clinically significant abnormal laboratory measures.
The most common adverse events were nausea, diarrhea, headache, injection site bruising and insomnia, the Cambridge, Massachusetts-based company said in the statement. (Reporting by Esha Dey in Bangalore; Editing by Sriraj Kalluvila)
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