HLB confirms ophthalmic disease treatment in phase 3 clinical trials

South Korea’s biomedicine startup HLB Therapeutics Co. said on Monday that its Neurotrophic Keratopathy (NK) treatment RGN-259 proved effective and safe in first phase 3 clinical trials (SEER-1).

The research report, published by the International Journal of Molecular Sciences on Dec. 29, last year, was carried in the journal’s special issue section, Dry Eye and Ocular Surface Disorders 4.0.

In the report, the research team comprising HLB researchers and US clinicians confirmed the efficacy and safety of RGN-259 for NK patients.

Before the paper's publication, HLB confirmed the statistical significance of the RGN-259 effect in 18 patients and presented it at a 2022 meeting of the Association for Research in Vision and Ophthalmology.

NK is a degenerative corneal disease that causes a decrease or loss of corneal sensation. Damages to corneal epithelial tissue at the initial stage develop into serious symptoms such as ulcers, melting, and perforation if they are not appropriately treated.

Herpes zygomatic corneitis, chemical burns, long-term use of contact lenses, systemic diseases such as corneal surgery, diabetes, and multiple sclerosis are the main causes.

Artificial tears or autologous serum eye drops are used if the symptoms are mild, but as the symptoms worsen, eyelid suture, conjunctival plate sheath surgery, and amniotic transplantation may be required.

Thymosin beta-4 (T4), a substance of RGN-259, is deemed the most popular treatment candidate for new drugs in ophthalmic diseases because it can treat corneal wounds, promote cell migration, and has anti-inflammatory effects. It has been designated as a rare drug for NK by the US FDA and is still under development by ReGenTree, HLB Therapeutics’ US subsidiary.

"Although 65,000 patients are currently suffering from this disease in the US alone, the only treatment, Oxervate (cenegermin-bkbj) is very expensive with a price of $100,000 for eight weeks of treatment and is inconvenient for administration and product storage," said HLB Therapeutics CEO Ahn Ki-hong.

“HLB will focus on two phase 3 clinical trials (SEER-2 and SEER-3) simultaneously underway in the US and Europe to make RGN-259 a 'best-in-class' global drug," he added.

Write to Jae-Young Han at jyhan@hankyung.com