HanAll Biopharma and Daewoong Pharmaceutical said that they have presented the U.S. phase 3 clinical trial topline results for HL036, a dry eye treatment candidate.

HL036, also known as Tanfanercept, is a new biological drug that can treat dry eye syndrome, which causes eye surface damage, irritation and foreign body sensation caused by the lack of tears or excessive evaporation. It has a new mechanism of inhibiting TNFα that causes inflammation in the eye.

The company has been conducting the phase 3 clinical trial at 12 medical institutions in the U.S. through Ora, a local contract research organization.

The trial, titled VELOS-2, randomly divided 630 patients with dry eye syndrome into two groups and administered HL036 0.25 percent twice a day for eight weeks or a placebo to compare the efficacy and safety of the treatment.

As an objective measure of efficacy, the company used corneal staining score (CSS) to directly measure the extent of improvement of the damaged cornea, while using the ocular discomfort score (ODS) as a subjective indicator to survey the patient's discomfort.

The safety assessment was performed by recording all systemic adverse events during the dosing period and analyzing the differences and drug associations between the placebo and HL036 dose groups.

As a result, HL036 0.25 percent eye drops showed statistically significant improvement compared to placebo in the total corneal staining score (TCSS), an objective indicator that collectively reflects the effect of the entire cornea.

TCSS measured the effect at each site by dividing the cornea into inferior, central, and superior, and summed the impact on the whole eye. The method is a far more clinically meaningful indicator compared to the inferior corneal staining score, which was shown to be significant in phase 2 clinical trial (VELOS-1).

Concerning the ODS index, HL036 0.25 percent eye drops significantly improved it compared to the placebo group two and four weeks after initiation.

All adverse events during the clinical trials were minor, and there was no difference in the incidence between HL036 eye drops and placebo.

"Although much progress has been made in the recent understanding of dry eye syndrome, millions of patients still crave more effective treatments," said Professor George Ousler, the lead investigator of the trial. "In this trial, the effect of HL036 treating the corneal damage was not limited to specific areas of the cornea, but appeared throughout the cornea."

Also, the subjective improvement effect of HL036 appears rapidly two and four weeks after administration. Hence, the team expects to shorten the second phase 3 clinical trial when considering the improvement period, Ousler added.

HanAll Biopharma CEO Park Seung-kook also said, "The final results will be presented at overseas ophthalmology conferences after completing various sub-group analyzes such as biomarker analysis and correlation of disease severity and HL036’s effect."

Based on the results of the first phase-3 clinical trials, the company will proceed ahead with licensing agreements with overseas partners, while preparing for the second phase-3 clinical trials, Park added.

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