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HanAll Biopharma and Daewoong Pharmaceutical Announced the Result of Phase 2 Clinical Trial of HL036 (a new drug for dry eye syndrome) in the U.S.


Related Data
- Confirmed significance of both inhibition of corneal injury and relief of dry eye syndrome
- Will enter phase 3 clinical trial and discuss technology transfer with an overseas partner at the same time

HanAll Biopharma and Daewoong Pharmaceutical today announced the topline results of phase 2 clinical trial in the U.S. of HL036, a new bio drug for dry eye syndrome, which has been jointly developed by them. The phase 2 clinical trial of HL036 was conducted at two ophthalmic clinical trial institutions in Boston, USA through Ora, a US ophthalmic contract research organization (CRO).

Phase 2 clinical trials of HL036 were performed by administering 0.1% and 0.25% eye drops of HL036, and placebo to 50 dry eye patients in each group, twice a day for 8 weeks. As for validity indexes, Inferior Corneal Staining Score (ICSS) was used to observe the degree of corneal damage in patients and Ocular Discomfort Score (ODS) to investigate subjective discomfort of eyes.

According to the results of trials, a statistically significant improvement effect of the 0.25% HL036 eye drops compared to the placebo was observed in the ICSS change, which is an evaluation index of comparing the ICSS values before and after exposure to the dry environment, at 4 weeks after the drug was administered, and the effect lasted until the end of the 8 weeks of dosing. In the results of ODS, HL036 eye drops showed a significant improvement compared to placebo from 1 week after administration, and this effect continued until the end of the 8 weeks of dosing. Significant improvement in the subjective symptoms of a patient such as itching and burning sensation in the eyes was also confirmed. On the whole, HL036 showed rapid onset compared to its competitors, and it was confirmed that the side effects were significantly less than those of the existing licensed competitors.

Dr. George Ousler, head of the clinical study, said, “Previous clinical trials have shown that it is not easy to obtain meaningful results in both Sign (objective sign of a disease) and Symptom (subjective symptom felt by the patient) in a small phase 2 clinical trial on dry eye syndrome, but HL036 achieved meaningful results in both indices.” “Based on the information identified in phase 2 clinical trials, the ICSS change and ODS should be tested as the primary endpoint in phase 3 clinical trials,” he added. 

An official of HanAll Biopharma said, “We announced the topline result of phase 2 clinical trials that has been secured until now. After completing various sub-group analyses such as a biomarker analysis, an analysis on correlation of disease severity and HL036 effect, in 3Q, we will announce the final results this fall at overseas ophthalmological societies. HanAll and Daewoong Pharmaceutical will continue to discuss technology transfer with overseas partners based on the results of phase 2 clinical trials, and in parallel, it will enter phase 3 clinical trials internally.

HL036, the treatment of dry eye syndrome is a biopharmaceutical drug developed by HanAll Biopharma, which developed the eye drops with the molecular development of TNF receptor fragment that inhibits actions of TNF by using the original technology of Resistein. It concluded a joint development contract with Daewoong Pharmaceutical in 2016 and is conducting global clinical development. In September last year, the rights for HL036 business in China including rights for HL161 were exported to Harbour Biomed for USD 81 million.

Dry eye syndrome is a disease caused by lack of tear production or excessive evaporation of tears, resulting in ocular surface damage, which is caused by increased osmotic pressure in the tear and accumulation of inflammatory substances. The number of patients with dry eye syndrome has been increasing due to the recent aging, excessive use of smart phones, and the use of heating and air-conditioning devices. As a result, the global market size is KRW 3.8 trillion and the annual growth rate is 7%.