Huons Dry Eye Drug Candidate Demonstrates Safety and Tolerability in Phase 1 Trial
Huons Group has confirmed the safety and tolerability of its new drug candidate for dry eye disease through a Phase 1 clinical trial.
On the 28th, Huons Group announced that Huons Co., Ltd. had received the Clinical Study Report (CSR) for the Phase 1 trial of its dry eye treatment, "HUC1-394."
HUC1-394 is a peptide-based ophthalmic solution introduced from Novacell Technology Co., Ltd. It selectively binds to the formyl peptide receptor 2 (FPR2), which regulates inflammatory responses. By activating FPR2, it modulates and alleviates inflammatory signaling.
In January of last year, Huons received approval from the Ministry of Food and Drug Safety for the domestic Phase 1 clinical trial plan for HUC1-394 and conducted the trial with 60 healthy adult participants. To evaluate the safety, local tolerability, and pharmacokinetic characteristics of HUC1-394, both single ascending dose (SAD) and multiple ascending dose (MAD) studies were performed.
The clinical results confirmed the safety and tolerability of HUC1-394 in both single and repeated administrations. No serious adverse events (SAEs) occurred. Most treatment-emergent adverse events (TEAEs) were mild and resolved during the observation period. The types and frequencies of TEAEs were not observed to have any particular association with the dose or administration period of HUC1-394.
Huons expects that HUC1-394 will improve keratoconjunctivitis and restore damaged corneas caused by dry eye disease, while also reducing inflammation-the main cause of dry eye-and the potential for side effects.
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Based on these Phase 1 results, Huons plans to proceed with subsequent clinical trials. Park Kyungmi, Executive Vice President of Research and Development at Huons, stated, "Through the Phase 1 clinical trial of the HUC1-394 ophthalmic solution, we have confirmed its safety and tolerability," adding, "We expect to provide an alternative treatment for dry eye disease through further clinical studies."
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