Huons Gains IND Approval for Phase 2 Clinical Trial of New Drug for Dry Eye Syndrome

[Shin-Min Joon, Edaily Reporter] Huons has advanced to the next stage in developing a new drug with a novel mechanism of action for dry eye syndrome.

Huons CI. (Image=Huons)

Huons announced on March 12 that it has received Investigational New Drug (IND) approval on March 11 from South Korea‘s Ministry of Food and Drug Safety (MFDS) to imitate a Phase 2 clinical trial of ’HUC1-394‘, a new treatment candidate for dry eye syndrome.

HUC1-394 is a peptide-based ophthalmic solution licensed from NOVACELL Technology Inc. The drug selectively binds to the ’Formyl Peptide Receptor 2 (FPR2)‘ a receptor involved in the body’s natural resolution of inflammation and activates it to alleviate inflammatory response.

By promoting proper resolution rather than simple suppression of inflammation, HUC1-394 is expected to accelerate tissue repair and fundamentally improve keratoconjunctivitis inflammation of both the cornea (keratitis) and the conjunctiva (conjunctivitis) caused by dry eyes by disease.

In the Phase 1 clinical trial conducted in 60 healthy adults, HUC1-394 demonstrated favorable safety and tolerability profile with no serious adverse event (SAE) observed following Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) ocular administrations. These results provide sufficient evidence to support further clinical development.

With this IND approval, Huons will imitate a Phase 2 clinical study in approximately 150 patients with dry eye syndrome at major medical centers including Severance Hospital, Yonsei University College of Medicine. The multi center, randomized, double blind trial will evaluate the safety, efficacy and optimal dosing regimen of HUC1-394.

Huons expects that HUC1-394 will effectively control inflammation the primary cause of dry eye syndrome while minimizing potential side effect offering a safer and more targeted treatment option.

Kyung mi Park Vice President and Head of R&D at Huons stated “Based on the results of the Phase 1 study we have validated the rationale for progressing to the next clinical stage. With this IND approval we will proceed seamlessly with the Phase 2 trial to deliver a new therapeutic option for patients suffering from dry eye syndrome.”