Theragen ETEX said it has signed a technology transfer agreement related to TEJ-1704, an orally administrable derivative candidate for Radicut Injection, a Lou Gehrig's Disease treatment, with J2H Biotech.
Theragen plans to complete the preclinical trial for the candidate and apply for phase 1 clinical trials to the Ministry of Food and Drug Safety next year.
Although the company expects to conduct clinical trials for five to seven years, Theragen believes that the process can accelerate as Radicut Injection, the drug’s original, has already been designated as an orphan drug. The company also expects that that global license outs will become possible after the completion of phase 1 clinical trials.
Successful development of oral formulations of Radicut Injection means that patients with Lou Gehrig's disease do not have to visit the clinic regularly to get an injection, as well as removing the need to have a restraint to control the drug's body concentration.
“This technology transfer is meaningful because it has laid the foundation for developing effective and convenient therapeutic drugs for Lou Gehrig's disease,” Theragen ETEX CEO Ryu Byung-hwan said. “We will continue to focus our research capabilities on new drug development and enhance our future growth potential.”