HanAll Biopharma said that it has failed to meet the primary endpoint for its phase 3 clinical trial for HL036, a dry eye treatment jointly developed with Daewoong Pharmaceutical.
|HanAll Biopharma CEO Park Seung-kook explains the meaning of its phase 3 clinical trial topline results, during a news conference at the InterContinental Seoul Coex, on Tuesday.|
HL036, also known as Tanfanercept, is a new biological drug that can treat dry eye syndrome, which causes eye surface damage, irritation and foreign body sensation caused by the lack of tears or excessive evaporation. It has a new mechanism of inhibiting TNFα that causes inflammation in the eye.
The company has been conducting the phase 3 clinical trial at 12 medical institutions in the U.S. through Ora, a local contract research organization.
The trial, titled VELOS-2, randomly divided 630 patients with dry eye syndrome into two groups and administered HL036 0.25 percent twice a day for eight weeks or a placebo to compare the efficacy and safety of the treatment.
"The new dry eye drug HL036 did not achieve the primary endpoint," HanAll Biopharma CEO Park Seung-kook said in a news conference Tuesday. "The company failed to meet ocular discomfort score (ODS), which was the primary endpoint, as the drug failed to make a significant improvement compared to the placebo group at weeks 2 and 4 after administration."
However, in Ehlers Danlos Syndrome (EDS), which was used as a subjective indicator, HL036 0.25-percent eye drops significantly improved symptom after the eighth week compared to its competitor Xiidra.
"While the primary endpoint for interior corneal staining score (ICSS) did not have significant results, the company saw a meaningful improvement in the clinical and commercially significant corneal staining scores (CSS) and total corneal staining scores (TCSS)," Park said. "CSS is clinically more meaningful than ICSS in that it is an indicator that identifies the central area of the cornea, which is the main function of the cornea."
Although Xiidra received its license based on the ICSS, the company would be more competitive commercially if licensed as it demonstrated its effectiveness across the cornea, including TCSS, Park added.
"We did not announce that we failed our clinical trial as the dry eye clinical trials are approved after a single clinical trial, like anticancer drugs or rare drugs," Park said. "When it's approved, it's determined by a comprehensive analysis of the results, including several studies in HL036."
The company also stressed that it is planning to change the clinical design, which put ICSS and ODS as the primary indicators.
"The probability of selecting TCSS as an objective indicator and EDS as a subjective indicator has become a real possibility," said Shin Min-jae, the alliance manager for HanAll Biopharma. “Although we plan to consult with the U.S. Food and Drug Administration, we intend to put the indicators that performed well in the existing clinical trials as the primary endpoint."
The company plans to conduct two additional phase 3 clinical trials.
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