Huons has begun a phase 2 clinical trial to evaluate the safety and efficacy of its peptide-based dry eye disease drug candidate "HUC1-394."
Huons said on the 3rd that it completed first patient in (FPI) in its phase 2 clinical trial of the dry eye disease treatment "HUC1-394." The company proceeded with patient screening after receiving approval for the phase 2 investigational new drug (IND) application from the Ministery of Food and Drug Safety in March.
HUC1-394 is a peptide-based eye drop that Huons in-licensed from Novacell Technology. It works by activating formyl peptide receptor 2 (FPR2), which is involved in the resolution of inflammation in the body. Rather than only suppressing inflammation, it aims to fundamentally treat dry eye disease by promoting the normal termination of the inflammatory response and the recovery of damaged tissue.
The phase 2 trial will enroll 150 patients with dry eye disease at major medical institutions in Korea, including Severance Hospital at Yonsei University College of Medicine. Using a multicenter, randomized, double-masked design, the study will evaluate the safety and efficacy of HUC1-394.
The company plans to complete the phase 2 trial in the second half of next year and secure a clinical study report (CSR). If efficacy and safety are confirmed, it will begin preparations for phase 3.
Park Kyung-mi, executive vice president and head of research and development at Huons, said, "With the first patient in as a starting point, we will work closely with the research team to accelerate development," and added, "We will do our best in development to provide a new treatment option for patients with dry eye disease."