- Phase III trial enrolls 630 patients with dry eye disease at 11 clinical sites across the U.S.
- HanAll expects to report topline data before the end of the year following the initiation of treatment in the first patient in March.
- HL036 is the first drug development project under a 50/50 investment partnership between HanAll and Daewoong Pharmaceutical.
HanAll Biopharma (CEOs: Seung-kook Park/Jae-choon Yoon) announced today that the company entered a phase III clinical trial (VELOS-2) of "HL036," an investigational biologic for the treatment of dry eye disease, with the eye drop administered to the first patient in the trial. HanAll and Daewoong Pharmaceutical are co-developing the anti-TNF antibody under a joint investment partnership.
The phase III clinical trial of HL036 randomized 630 patients with dry eye disease to receive a 0.25% eye drop of HL036 twice daily for 8 weeks or a placebo to evaluate the efficacy and safety of HL036 0.25% eye drop vs. placebo.
The phase III clinical of HL036 has been registered on a registry of clinical trials run by the U.S. government (clinicaltrials.gov), and will begin at 11 clinical sites across the U.S. in March 2019. The company expects to report topline data by December 2019.
The results of the phase II clinical trial (VELOS-1) show that HL036 eye drop was associated with statistically significant improvement compared to placebo before and after exposure to the dry environment, assessed based on Inferior Corneal Staining Score (ICSS) and Ocular Discomfort Score (ODS). The results were presented at the Ophthalmology Innovation Summit (OIS) meeting in October 2018, and the final data including an analysis of subgroup will be presented at the Association for Research in Vision and Ophthalmology (ARVO) in Canada in April 2019.
HL036 is a biologic drug for the treatment of dry eye disease, a condition characterized by damaged eye surfaces and associated with symptoms including irritation and discharge. Based on a new mechanism of action, it works by inhibiting TNFα which is responsible for inflammation of the eyeball.
"The phase III clinical trial of HL036 represents a significant milestone in our continued focus on development of a global biologic drug," said Seung-kook Park, CEO of HanAll Biopharma. "We believe that the results of the trial will help us to see strong clinical effectiveness of HL036 statistically, thereby, positioning the drug as an innovative therapy in dry eye disease where there are high unmet needs."
"HL036 is the first biologic project developed under a joint investment partnership between Daewoong and HanAll," said Seung-ho Jeon, CEO of Daewoong Pharmaceutical. "We are committed to improving the quality of patients’ lives, expanding patients’ choice in dry eye disease where patients are facing limited options."
Worldwide, as many as 300 million people experience dry eye disease, but only 17% of them receive medical care, according to the data released by market research firm Market Scope. The global market for dry eye disease treatments is estimated to be $3.6 billion in 2017, and expected to top $6.6 billion by 2027 as it continues to grow fueled by excessive use of smartphones and environmental changes including micro-dust.