Huons, a South Korean pharmaceutical company specializing in ophthalmic and injectable medicines, said Thursday it has received Investigational New Drug approval from the Ministry of Food and Drug Safety to begin a Phase 2 clinical trial of its dry eye treatment candidate.
HUC1-394 is a peptide-based ophthalmic solution licensed from Novacell Technology. The drug selectively binds to Formyl Peptide Receptor 2 (FPR2) — a receptor involved in the body’s natural resolution of inflammation — activating it to reduce inflammatory responses.
Unlike conventional treatments that mainly suppress inflammation, the candidate aims to promote the body’s natural inflammation-resolution process, which could accelerate tissue repair and improve keratoconjunctivitis, a condition affecting both the cornea and conjunctiva commonly associated with dry eye disease.
In a Phase 1 clinical trial involving 60 healthy adults, the drug showed favorable safety and tolerability. No serious adverse events were reported during single-ascending-dose and multiple-ascending-dose ocular administrations.
Following the IND approval, Huons plans to conduct a Phase 2 trial involving about 150 patients with dry eye disease at major medical centers, including Severance Hospital at Yonsei University College of Medicine.
The multicenter, randomized, double-blind study will evaluate the safety, efficacy and optimal dose of HUC1-394.
Huons said the drug candidate is designed to control inflammation while minimizing side effects, potentially offering a safer and more targeted treatment option for patients.
“Based on the Phase 1 results, we confirmed the rationale for advancing to the next stage of clinical development,” said Park Kyung-mi, vice president and head of research and development at Huons. “Following the IND approval, we will proceed with the Phase 2 trial to provide a new treatment option for patients with dry eye disease.”
jwjeon7625@heraldcorp.com
