HanAll Biopharma : Daewoong Announces Topline Results for HL036 Phase 3 study at a Press Conference
January 29, 2020 at 07:13 pm IST
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HanAll Biopharma and Daewoong Pharmaceutical announced topline results from the first US Phase 3 study of HL036 for treatment of dry eye (VELOS-2 study) at a press conference on January 21st.
The VELOS-2 study was conducted in dry eye patients across 12 clinical sites in the United States in collaboration with Ora Inc., a US-based ophthalmic CRO (Contract Research Organization). 637 patients were divided into 2 groups to receive HL036 ophthalmic solution 0.25% or Placebo twice daily for 8 weeks.
For efficacy evaluations, the objective endpoint (Sign) was measured by assessing the improvement of corneal damage at each corneal area including, superior (SCSS), central (CCSS), and inferior (ICSS), and also the total sum of these corneal areas (TCSS). The subjective endpoint (Symptom) was measured by the Ocular Discomfort Score (ODS), a patient-reported assessment of eye discomfort, and Eye Dryness Score (EDS), a patient-reported evaluation of eye dryness. Safety evaluations included all adverse events, not limited to ophthalmic events, that occurred in both groups during the dosing period and analyzed rates between the two groups and association of adverse events to drug exposure.
The VELOS-2 study confirmed statistical significance of HL036 0.25% ophthalmic solution in the endpoints CCSS (p=0.0239), a measure of improvement in central corneal damage, and TCSS (p=0.0452), a measure of improvement across total corneal regions. Achievement of statistical significance in TCSS and CCSS has higher clinical importance than significance observed in ICSS from the HL036 Phase 2 (VELOS-1) study, because TCSS and CCSS reflect ocular surface damage in the most sensitive areas of the cornea and its effect on vision, while ICSS only reflects damage in the lower corneal zone where staining can occur even in normal subjects.
In symptom evaluations, HL036 ophthalmic solution 0.25% demonstrated significant improvement in Ocular Discomfort Score (ODS) from week 2 (p=0.0624) and week 4 (p=0.0570) compared to placebo, but did not achieve statistical significance (p
Hanall Biopharma Co Ltd is a Korea-based company principally engaged in the manufacture and distribution of synthetic pharmaceuticals and biopharmaceuticals. The Company mainly manufactures and sells pharmaceutical products including antidiabetic drugs, skin drugs, muscle relaxants, hepatitis drugs, digestion drugs, anti-cardiovascular drugs, neurologic drugs, interferons, antiviral drugs, antibiotics, antihistamine, anti-inflammatory drugs, and others. The Company also engages in the leasing of real estates. The Company distributes its products in domestic and overseas markets.
HANALL BIOPHARMA CO., LTD. 
