Huons, a leading South Korean pharmaceutical company specializing in innovative ophthalmic and injectable solutions, announced Thursday that it has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) to initiate a Phase 2 clinical trial for its novel dry eye disease treatment candidate, HUC1-394.
HUC1-394 is a peptide-based ophthalmic solution in-licensed from Novacell Technology. This groundbreaking drug works by selectively binding to Formyl Peptide Receptor 2 (FPR2), a key receptor involved in the body’s natural inflammatory resolution processes. Activating FPR2 helps to modulate and reduce inflammatory responses associated with dry eye syndrome.
Unlike conventional dry eye treatments that primarily focus on suppressing inflammation, HUC1-394 aims to stimulate the body’s inherent inflammation-resolution pathway. This innovative approach may accelerate tissue repair and significantly improve keratoconjunctivitis, a common condition affecting both the cornea and conjunctiva that is frequently linked to dry eye disease.
The Phase 1 clinical trial, which involved 60 healthy adult participants, demonstrated a favorable safety and tolerability profile for HUC1-394. Notably, no serious adverse events were reported during either the single-ascending-dose or multiple-ascending-dose ocular administration phases of the study.
Following the IND clearance, Huons is set to commence a Phase 2 clinical trial involving approximately 150 patients diagnosed with dry eye disease. This trial will be conducted at prominent medical centers, including Severance Hospital at Yonsei University College of Medicine, ensuring a diverse and robust patient population.
The multicenter, randomized, double-blind Phase 2 study will thoroughly evaluate the safety, efficacy, and optimal dosage of HUC1-394 for the treatment of dry eye disease.
Huons emphasizes that HUC1-394 is specifically designed to effectively control inflammation while minimizing potential side effects. This offers a potentially safer and more targeted therapeutic alternative for patients suffering from dry eye.
“The encouraging results from our Phase 1 trial provided a strong rationale for progressing to the next phase of clinical development,” stated Park Kyung-mi, Vice President and Head of Research and Development at Huons. “With this IND approval, we are eager to move forward with the Phase 2 trial, bringing us closer to providing a much-needed new treatment option for patients struggling with dry eye disease.”
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