HanAll Biopharma (KRX: 009420.KS) today announced that its poster of the VELOS-2 study for dry eye disease was selected as “Best Poster” at the American Academy of Ophthalmology (AAO) 2020, held online from the 13th to the 15th of this month. It also drew the attention of participants by being ranked 7th in the “Top 100 Views”, which ranks the entered scientific posters in terms of the number of times it is viewed.
HanAll Biopharma developed an “anti-TNF substance suitable for local administration” through molecular optimization of the TFN receptor 1, with a function to suppress TNF to local administration and increasing its TNF suppression ability. This substance is registered with the WHO under the international non-proprietary name of “tanfanercept”. Since 2016, HanAll Biopharma has been conducting global clinical development targeting dry eye disease with Daewoong Pharmaceutical as its partner.
In March of last year, HanAll Biopharma and Daewoong Pharmaceutical began clinical trials for around 640 dry eye disease patients in the U.S. The top-line result was produced in the first half of this year and was announced at the AAO. The patients that participated in the clinical trials were administered with the HL036 eye drop twice a day over eight weeks. During the period of administration, the degree of improvement in the objective signs and subjective symptoms was measured.
As a result of the Sign clinical trial, the significant improvement effect of HL036 could not be verified through the ICSS (inferior corneal staining score), which was set as the primary endpoint, because it was displayed as p=0.187. However, with the CCSS (central corneal staining score) and TCSS (total corneal staining score), significant improvement effects were observed as the values were recorded as p=0.024 and p=0.045, respectively. In particular, in the group of patients with severe corneal damage prior to drug administration, the CCSS difference between the place and HL036 administration groups was p<0.001 or lower, a significant difference. At this session of the AAO as well, attention was drawn by the fact that the effect of this drug was observed in the central cornea and the effect was clearer in patients with severe conditions.
In the Symptom clinical trials to observe patients’ subjective symptoms, the EDS (eye dryness score) indicated a significant improvement (p=0.0334) in the group of patients that had used artificial tears within one month prior to their participation in the clinical trials in comparison to the placebo group.
HanAll Biopharma and Daewoong Pharmaceutical are preparing for the follow-up Phase 3 clinical trials based on the results of the first clinical trials. With the clinical development plan finalized through a meeting with the FDA, which is scheduled to take place in January next year, HanAll Biopharma will conduct a test to verify reproducibility of the improvement effect displayed in the clinical trials.
AAO is one of the world’s largest associations of opthalmology, with around 32,000 eye physicians and surgeons registered as members. At the annual conference, ophthalmologists and pharmaceutical companies share information and trends of new technologies.