A treatment for a rare obesity treatment, originally developed by South Korea’s Chong Kun Dang Pharmaceutical and licensed to Zafgen in 2009, is geared to fully resume clinical trials in the near future.

Zafgen, a U.S. biopharmaceutical company, said last week that beloranib has shown proven effectiveness in reducing body weight in a final-stage clinical study which was temporarily halted by the U.S. Food and Drug Administration last year.

The FDA took the decision after the company confirmed the death of two patients during the Phase III clinical trials of the obesity treatment in October and December 2015, clouding the prospects of the treatment’s future development and commercialization.
 

Zafgen’s announcement -- that beloranib demonstrated a significant reduction in body weight as well as abnormally increased appetite, becoming the first drug candidate to do so -- raised hopes that the FDA would lift its partial ban.

Beloranib treats Prader-Willi syndrome, a genetic disorder causing unrelenting hunger which leads to life-threatening obesity. There is currently no cure for the disease, which affects one in 12,000 to 15,000 people, according to the Prader-Willi Syndrome Association. 

Zafgen’s chief executive Thomas Hughes said in a statement that “the clear efficacy outcome is a crucial first step in moving discussions forward with the FDA regarding continued development of beloranib.”

The company plans to present the trial’s data and a strategy to mitigate the drug’s potential risks to the FDA after wrapping up the study within the quarter, according to Hughes.

The continuation of the Phase III clinical trials on beloranib is set to greatly influence the market value and profit outlook of both Zafgen as well as CKD. The two drug makers are expecting to reap sizeable profits upon the commercialization of the new obesity treatment.

Industry watchers say that beloranib takes up more than 80 percent of CKD’s entire lineup of new drug development porfolio, given the vast market potential of the obesity treatment.

As of the end of 2015, CKD has reportedly received some $8 million in development milestones, including an upfront payment of $500,000, under the licensing agreement.

By Sohn Ji-young (jys@heraldcorp.com)