바이오스펙테이터

바이오스펙테이터 Sungmin Kim 기자

The efficacy of HL036 was assessed by two primary endpoints of its phase 2 clinical trial "top-line results of the Phase 3 clinical trial by December of this year"

HanAll BioPharma announced on February 10th, 2019 that it started in Phase 3 clinical trial the first administration of ‘HL036’, a new treatment for dry eyes that has been jointly developed with Daewoong Pharmaceutical Co., Ltd. HL036 is an antibody fragment targeting TNF-α, and its molecular weight is 19 kDa. Its small size enables local administration, and it has the same level of affinity as the existing TNF-α, but with improved stability.

The Phase 3 clinical trial (VELOS-2) is being conducted at 11 clinical trial centers in the U.S., with the aim of producing topline data by December of this year (NCT03846453).

In Phase 3 clinical trial, 630 patients were divided into two groups. One group was administered with HL036 (nonproprietary name: tanfanercept) 0.25 % ophthalmic solution twice per day for a period of 8 weeks, while the other group was administered with placebo ophthalmic solution. The first primary endpoint of Phase 1 clinical trial was set up as the inferior corneal staining score (ICSS), which can evaluate the efficacy of the ophthalmic solution; the second primary endpoint was set up as the ocular discomfort score (ODS), for subjective symptom evaluation.

HanAll BioPharma completed the Phase 2 clinical trial (VELOS-1) of HL036 in 150 subjects with dry eyes. According to the results of the clinical trial, both the ICSS and the ODS, which are the objective and subjective tools to evaluate symptoms, respectively, showed improvement in efficacy against the placebo ophthalmic solution, when compared before and after exposure to a dry environment. After four weeks of administration, the experimental drug started to show significant improvement in efficacy, and such improved efficacy was maintained until the end of 8 weeks, which is the end of administration.

HanAll BioPharma announced the results at the Ophthalmology Innovation Summit (OIS) of the American Academy of Ophthalmology in October 2018, and is expected to release the final results, including the analysis results of the subgroups, next month at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Conference.

HL036 is a new bio-drug for dry eyes with irritation and foreign body sensation caused by insufficient tears and excessive evaporation of tears. It will function as a mechanism to inhibit TNF-α, which can cause inflammation.

HanAll BioPharma CEO Park Seung-Guk said, “The entry of HL036 into Phase 3 clinical trial in the U.S. will be an important milestone for HanAll, who are concentrating on the development of new global bio-drugs. The outstanding clinical efficacy of HL036 was confirmed by statistical data, and it is expected to become an innovative treatment in the dry eye market segment that has a high level of unmet needs.

Daewoong Pharmaceutical CEO Jeon Seung-Ho said, “HL036 is the first project jointly invested in by Daewoong and HanAll to develop new bio-drugs. We will continue to make efforts to expand the limited selection of treatments for patients with dry eyes, and to improve their quality of life.”

In the meanwhile, the global market size for dry eye treatment as of 2017 was estimated to be 4 trillion won, according to the data released by Market Scope, a market survey agency. The market is currently expanding at an annual rate of 7 % due to the excessive use of smartphones and environmental change, including PM fine dust, and by 2027 is expected to increase to 7 trillion won.