HanAll Biopharma, a subsidiary of Daewoong Pharmaceuticals, said Wednesday that it has presented its Topline phase 2 clinical trial results for HL036, a dry eye treatment.

Phase 2 clinical trials, run by Ora, a U.S. contract research organization (CRO), divided 150 patients into three groups and administered either 0.1 percent, 0.25 percent HL036 eye drops, or placebo to each group, twice a day for eight weeks. The CRO used Inferior Corneal Staining Score (ICSS) to observe the degree of corneal damage in patients and Ocular Discomfort Score (ODS) to investigate the subjective discomfort of eyes.

Test results showed ICSS Change, an evaluation index for comparing the ICSS values before and after exposure to the dry environment, improvement in patients administered with 0.25 percent HL036 after four weeks of treatment compared with the placebo group. The effect also lasted up to eight weeks.

Regarding ODS, HL036 eye drops showed a significant improvement compared to placebo from a week after administration and the effects continued until the end of the trial.

The treatment also showed significant improvement in the subjective symptoms of the patient such as itching and burning sensation in their eyes. Also, HL036 showed rapid onset compared to the competition and confirmed that the side effects were significantly lower than those of existing licensed competitors.

“Previous clinical trials have shown that it is not easy to obtain meaningful results for both the sign and symptom in a small scale phase 2 clinical trial for dry eye syndrome,” said Professor George Ousler, head of the study. “However, HL036 yielded meaningful results in both cases.”

He went on to say, “Based on the information identified in phase 2 clinical trials, we plan to test ICSS change and ODS as the main evaluation variable in our phase 3 clinical trials.”

HanAll also appeared encouraged by the positive result.

“We plan to publish the final results, including biomarkers analysis and correlation analysis of the severity of disease and HL036 effects in the third quarter of this year,” a company official said. “HanAll and Daewoong Pharmaceutical will proceed with technology transfer negotiations with overseas partners based on the results of phase 2 clinical trials. Internally we plan to enter phase 3 clinical trials soon.”

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