HanAll Biopharma said that Harbour Biomed, its Chinese partner, has completed phase 2 clinical trials of HBM9036, a dry eye treatment.
Harbour Biomed tested the efficacy and safety of the treatment in 100 patients with dry eye syndrome by applying HBM9036 0.25 percent or placebo twice daily for eight weeks. Professor Lixin Xie, a member of the Chinese Academy of Engineering, led the study at the Qingdao Eye Hospital.
HBM9036 eye drops rapidly improved the signs of dry eye symptoms (corneal damage) before and after exposure to the arid environment, set as the primary endpoint. The data were consistent with the results of HanAll's U.S. VELOS-1 Study released in April.
The company also reaffirmed the safety and tolerability of the drug, which was similar to that of the placebo. Harbour Biomed plans to unveil the data at an international conference in the future.
"Dry eye syndrome is complex and difficult to diagnose disease that has a significant impact on the patient's life," Xie said. "Recent studies show that dry eye patients are on the rise due to aging, increased use of smartphones, and the spread of fine dust."
Artificial tears which are commonly used in China, however, are used only to alleviate temporary symptoms, Xie added.
Xie stressed that the HBM9036's mechanism of action in the eye through tumor necrosis factor receptor 1 (TNFR1) could be an innovative approach.
"The successful results of the clinical trials will enable a more mature phase 3 design, which will bring greater hope for dry eye patients in China," Xie said.
Harbour Biomed CEO Jingsong Wang also said, "HBM9036 has the most advanced mechanisms for treating the underlying inflammation that exacerbates dry eye syndrome and is the first and foremost biopharmaceutical in the Chinese dry eye area."
Outstanding improvement in dry eye symptoms and an excellent safety profile has paved the way for phase 3 clinical trials in China, which will begin early next year, Wang added.
Hanall Biopharma licensed out two new bio drugs under development to Harbour BioMed at $81 million (91.5 billion won) in 2017.
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