Portland, Boston – Zafgen Inc. (NASDAQ: ZFGN) reported on Wednesday the second death in an obesity drug trial that aims to treat a rare genetic disorder linked to obesity. The first one occurred in October and the death cause remains unknown. This time, the patient died from a blockage in an artery in the lung, or blood clot, but it has not been proven if it was caused by the beloranib drug itself. The company’s shares dropped 63 percent in midday trading Wednesday, as it is uncertain if the trial will continue.
“We are investigating the circumstances around this event,” Chief Executive Officer Thomas Hughes declared in a press release.
Zafgen is discussing with the U.S. Food and Drug Administration (FDA) on what to do next in terms of beloranib’s development, the firm’s lead drug candidate.
After the first death in October, the drug testing was placed under a partial clinical hold by the Boston-based firm, which had been previously studying the drug on 108 patients and the most serious side-effect they found was bruising in the area where the injections were given.
With beloranib, the biotechnology company pretends to treat Prader-Willi syndrome, a rare genetic disorder that has multiple symptoms and is associated with obesity. The unusual condition makes patients feel always hungry, producing chronic overeating and also delayed development. According to Zafgen, Prader-Willi syndrome has a high rate of mortality linked to obesity-related conditions. Beloranib has also been tested in two other different kinds of appetite disorders.
Analysts from SunTrust Robinson Humphrey believe there is more than 40 percent chance of the drug’s success since it is not known if it actually induced the blood clot.
The FDA has recently approved drugs made by Vivus Inc, Orexigen Therapeutics Inc and Arena Pharmaceuticals Inc. Nevertheless, it has required the firms to carry on further studies in order to check the safety of these treatments. They all reduce appetite by connecting with nerve signals and make the brain think that the stomach is full. On the other hand, Zafgen’s beloranib aims to make the organism produce less fat and burn off the excess. The drug is designed to block methionine aminopeptidase 2, which is a key enzyme for fatty acids production and use.
The firm announced on Wednesday that results from previous stages of the trial are expected in the first three months of 2016.
Source: Reuters