Huons Advances Novel Dry Eye Treatment HUC1-394 to Phase 2 Clinical Trial
核心洞察
Huons (搜索) received IND approval from South Korea's Ministry of Food and Drug Safety to begin Phase 2 trials of HUC1-394, a peptide-based dry eye treatment.
The drug candidate selectively binds to Formyl Peptide Receptor 2 (搜索) (FPR2 (搜索)) to promote natural inflammation resolution rather than simply suppressing inflammation.
Phase 1 trials in 60 healthy adults demonstrated favorable safety and tolerability with no serious adverse events reported.
South Korean pharmaceutical company Huons (搜索) has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety to advance its dry eye treatment candidate HUC1-394 into Phase 2 clinical trials. The peptide-based ophthalmic solution represents a novel approach to treating dry eye disease by targeting the body's natural inflammation resolution pathways.
Novel Mechanism Targets Inflammation Resolution
HUC1-394, licensed from Novacell Technology (搜索), works by selectively binding to Formyl Peptide Receptor 2 (搜索) (FPR2 (搜索)), a receptor involved in the body's natural resolution of inflammation. Unlike conventional treatments that primarily suppress inflammation, the drug candidate aims to activate 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.
"The new drug is expected to go beyond simple inflammation suppression to properly terminate inflammatory responses and restore damaged tissue, thereby improving keratoconjunctivitis," Huons (搜索) explained. The company believes this mechanism could provide a fundamental treatment approach for dry eye disease.
Promising Phase 1 Safety Profile
The drug candidate demonstrated favorable safety and tolerability in Phase 1 clinical trials involving 60 healthy adults. No serious adverse events were reported during single-ascending-dose and multiple-ascending-dose ocular administrations, providing confidence for advancement to the next development stage.
"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 (搜索).
Phase 2 Trial Design and Objectives
Following the IND approval, Huons (搜索) plans to conduct a multicenter, randomized, double-blind Phase 2 study involving approximately 150 patients with dry eye disease. The trial will be conducted at major medical centers, including Severance Hospital at Yonsei University College of Medicine.
The Phase 2 study will evaluate the safety, efficacy, and optimal dose of HUC1-394 while reconfirming the drug's safety profile in the target patient population. Huons (搜索) maintains that the drug candidate is designed to control inflammation while minimizing side effects, potentially offering a safer and more targeted treatment option for patients.
Clinical Development Timeline
Park Kyung-mi emphasized the company's commitment to rapid development, stating, "Following the IND approval, we will proceed with the Phase 2 trial to provide a new treatment option for patients with dry eye disease. We will do our utmost to proceed with Phase 2 trials without delay and provide new treatment options to suffering patients."
The advancement of HUC1-394 represents Huons (搜索)' continued focus on ophthalmic and injectable medicines, with the potential to address unmet medical needs in dry eye disease treatment through its innovative inflammation resolution mechanism.