US pharmaceutical company Janssen will start carrying out phase 2 clinical trials in the US to evaluate the efficacy and safety of a diabetes drug candidate originally developed by South Korea’s Hanmi Pharmaceutical, the companies announced Wednesday.
The study was uploaded onto ClinicalTrials.gov, a website through which most pharma companies recruit participants for upcoming clinical trials, by Janssen under the drug code name JNJ-6456511.
Hanmi Pharmaceutical's headquarters in southern Seoul (Hanmi Pharmaceutical)
The study will involve 440 participants and assess the effects of JNJ-64565111 on non-diabetic, severely obese patients in comparison with a placebo after 26 weeks of treatment. It will track changes in participants’ body weight as well as the drug’s safety and tolerability.
JNJ-64565111, also known as HM12525A, is a biologic drug for the treatment of diabetes and obesity, originally developed by Hanmi. It was licensed out by Hanmi to Janssen in November 2015 in a deal valued at $915 million including an upfront payment and milestone payments.
The deal had initially drawn investor concerns in 2016 when Janssen suddenly suspended recruitment for the drug’s phase 1 clinical trials, intended to test the drug’s efficacy in treating patients with Type 2 diabetes mellitus, citing manufacturing issues.
In 2017, Janssen started and completed a new set of phase 1 clinical trials for the Hanmi-developed drug candidate, targeting patients diagnosed with severe obesity, but not diabetes. And now, the phase 2 clinical study for the drug has begun, according to Hanmi.
Following the news, shares of Hanmi Pharmaceutical closed at 51,900 won ($49) on Wednesday, up 3.8 percent from the previous day.
By Sohn Ji-young (
jys@heraldcorp.com)