[THE INVESTOR] Johnson & Johnson subsidiary Janssen Pharmaceuticals will initiate new clinical trials for expanded use of HM12525A, a drug candidate originally developed by Hanmi Pharmaceutical, for patients with diabetes and obesity, the Korean company said on July 18.

According to registry disclosure site clinicaltrials.gov, Janssen is planning a phase 2 clinical program on 188 severely obese Type 2 diabetics to evaluate the safety and efficacy of HM12525A, which the Belgium-based drug maker in-licensed from Hanmi in 2015 in a deal valued at US$915 million. 

The fresh plan shows Janssen’s willingness to prove that the drug candidate works in two ways simultaneously for controlling body weight and managing blood glucose levels.

In March, the company began a separate set of phase 2 studies on HM12525A, which is called JNJ-64565111by Janssen, involving 440 non-diabetic severely obese participants.

“The new phase 2 trials will be an impetus to the drug candidate to become an innovative biologic drug that can treat obesity and diabetes at the same time. We will closely cooperate with Janssen to commercialize HM12525A in a swift manner,” Hanmi Pharmaceutical CEO Kwon Se-chang said.

The clinical success of HM12525A is important for Hanmi as it is eligible for milestone payments on the outcome under the 2015 license deal. The contract 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.

By Park Han-na (hnpark@heraldcorp.com)