Huons Reports Safety and Tolerability Results of New Drug for Dry Eye Syndrome in Phase 1 Clinica...

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created on 11/28/2025 2:36:39 PM
modified on 11/28/2025 2:36:39 PM

[Shin-Min Joon, Edaily Reporter] Huons Group has confirmed the safety and tolerability of the new drug candidate for dry eye syndrome in clinical trial phase 1.

Huons CI. (Image=Huons)

Huons a pharmaceutical subsidiary of Huons Group announced on November 28th that it received phase 1 Clinical Study Result (CSR) for ‘HUC1-394’ eye drop on the 27th.

HUC1-394 is a peptide-based eye drop for dry eyes, licensed from NOVACELL Technology Inc. The drug selectively binds to ‘Formyl Peptide Receptor 2 (FPR2)’, which controls and reduces inflammation, then activates FPR2 to reduce and alleviate inflammation.

In January 2024 Huons has received approval on Investigational New Drug (IND) application from South Korea‘s Ministry of Food and Drug Safety (MFDS) for HUC1-394’s phase 1 clinical trial. The objective is to evaluate the safety, local tolerability, and pharmacokinetics of the HUC1-394 eye drop through Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) ocular administrations in 60 healthy adults.

Clinical trial results confirmed the safety and tolerability of single- and multiple-dose escalation study of HUC1-394. There was no Serious Adverse Event (SAE). Most of Treatment Emergent Adverse Events (TEAE) were in grade 1 (mild) and recovered within the observation period. It was determined that there was no close correlation between category and frequency of TEAE and dose and period of HUC1-394 administration.

Huons expects that HUC1-394 will alleviate symptoms of keratoconjunctivitis caused by dry eyes, restore damaged corneas and decrease possibility of inflammation and adverse effects which are the main causes of dry eye syndrome.

Huons will analyze the clinical trial results and conduct follow-up clinical trial.

Huons Vice President and Head of R&D Kyung-mi Park said “I am very proud to confirm the safety and tolerability of the HUC1-394 eye drop in Phase 1 clinical trial. We expect to be able to provide new treatment option for dry eye syndrome through follow up clinical trial.”