Huons enrolls first patient in Phase 2 trial of dry eye drug candidate HUC1-394

Huons is moving into full-scale clinical development of HUC1-394, its peptide-based eye drop candidate for dry eye disease.

The company announced Thursday that it had successfully enrolled the first patient in the Phase 2 trial of HUC1-394. Huons received investigational new drug approval for the trial in March, completed the patient screening process and enrolled the first patient on that day.

The Phase 2 trial will be conducted at major medical institutions in South Korea, including Severance Hospital at Yonsei University College of Medicine, and will enroll 150 dry eye patients. The multicenter, randomized, double-blind study will evaluate the safety and efficacy of HUC1-394 as the company begins building a clinical data set.

Huons aims to complete the last patient's last visit in the second half of next year, after which it plans to publish a clinical study report. If the Phase 2 data demonstrate sufficient efficacy and safety, the company said it will move immediately into Phase 3 preparations.

HUC1-394 is a peptide-based eye drop that Huons licensed from Novacel Technology. The drug candidate works by activating formyl peptide receptor 2 (FPR2), a receptor involved in the body's natural resolution of inflammation. Rather than simply suppressing inflammation, the compound is designed to bring the inflammatory response to a normal close and restore damaged tissue — an approach that researchers say could address the underlying causes of dry eye disease rather than its symptoms alone.

"Starting from the enrollment of the first patient in the Phase 2 trial, we will work closely with our research team to accelerate development," said Park Gyeong-mi, executive vice president and head of research and development at Huons. "We will do our best to provide an innovative treatment option for dry eye patients."