HanAll Biopharma Net Income for 2020 Increased by 14% Year-o..
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.