South Korean drug and medical device developer Dong-A ST Co.’s investigational drug to treat for diabetes and hepatitis licensed out to a U.S. pharmaceutical company is confirmed to fail to meet its primary end-point in a phase II study, following earlier news that another Korean pharmaceutical company Chong Kun Dang Pharmaceutical Corp.’s (CKD) phase II clinical study of its investigational obesity drug ended in failure.

Both failed trials cast cloud over Korean drug developers’ relentless efforts to license out their novel drugs.

According to sources on Wednesday, a phase II study of Dong-A ST’s non-alcoholic steatohepatitis (NASH) drug licensed out to Tobira Therapeutics Inc. last April recently ended in failure. Dong-A ST was supposed to receive up to $61.5 million for the global license deal that includes milestone payments on events related to clinical development, regulatory approval and commercialization. The failure means the Korean drug maker won’t be able to receive these conditional milestone payments.

The two companies planned to begin the development of DPP-4 Type 2 diabetes drug Suganon (evogliptin) and cenicriviroc combination therapy for NASH. Due to the failed trial, developing cenicriviroc (CVC) as a drug to treat hepatitis and diabetes faces uncertainty.

“With Tobira’s announcement of the failed study, Dong-A ST’s Suganon was revalued from 435.5 billion won ($396.4 million) to 130.5 billion won,” said Koo Wan-seong, an analyst at HI Investment & Securities.

The clinical study of Beloranib, an investigational drug for obesity licensed out by CKD to U.S. biopharmaceutical company Zafgen Inc. in 2009 also came to a stop recently. Zafgen discontinued its study as two patients died from thrombosis after being treated with Beloranib that was developed to treat Prader-Willi Syndrome, a disease related to obesity. The company terminated the program to develop Beloranib as indicated for Prader-Willi Syndrome and its study of the compound itself.

Currently, Hanmi Pharmaceutical Co. is the largest Korean drug maker in terms of the number of drugs under phase II trials approved by the U.S. Food and Drug Administration (FDA). It is conducting a phase II study of obesity and diabetes drug LAPS Exendin 4 and lung cancer drug HM61713 licensed out to Germany’s Boehringer Ingelheim.

Other Korean drugs under phase II trials include Green Cross’ Hunter Syndrome drug Hunterase, Dong-A ST’s diabetic neuropathy drug DA-9801, JW Pharm’s acute myeloid leukemia drug CWP-231A and Sillajen’s colorectal cancer drug Pexa-vec.

By Lee Dong-in

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]