‘ISU304 Type B Hemophilia’ Clinical Results Published in International Journal
Maximizing Patient Convenience with Differentiated Subcutaneous Injection Development
Expectations for a New Treatment Environment
[Asia Economy Reporter Hyungsoo Park] Isu Abxis announced on the 9th that the clinical 1/2a results of the biopharmaceutical drug ‘Dalcinoacog Alpha (DalcA)’, currently undergoing clinical trials with its U.S. partner Catalyst Biosciences, have been published in the international journal Journal of Thrombosis and Haemostasis.
DalcA is a treatment for hemophilia B, a rare disease caused by a deficiency of coagulation factor IX among various blood coagulation factors due to genetic defects. Isu Abxis has been developing DalcA together with Catalyst Biosciences since 2013. After Isu Abxis completed clinical phase 1/2a, the partner company finished phase 2b, and currently, phase 3 is being prepared.
According to the clinical results, DalcA showed 24 times higher efficacy compared to Pfizer’s BeneFIX, the longest-used hemophilia B treatment, and maintained a long-lasting effect in the blood for 33.8 hours. It also demonstrated that after once-daily administration for six days, 15.7% of coagulation factor IX activity was maintained in the blood, reducing the possibility of spontaneous bleeding in the body.
The company stated that based on these results, a 28-day clinical phase 2b trial was conducted to evaluate the long-term safety and efficacy of subcutaneous injection.
Dr. Seungbeom Hong, the lead researcher at Isu Abxis, introduced, “Hemophilia B is a disease that requires lifelong administration of coagulation factors,” and added, “The treatment paradigm is shifting toward more stable care along with patient convenience.”
He continued, “DalcA is the only hemophilia B treatment available in a subcutaneous injection form, enhancing dosing convenience,” and explained, “It will play a role in changing the treatment direction by maintaining higher activity in the blood compared to existing treatments.”
Isu Abxis has recently secured results proving its technological capabilities, such as the publication of consecutive new drug project papers. Based on the accumulated know-how in biopharmaceutical development and production, the company is expanding its new revenue business model to include CDMO (Contract Development and Manufacturing Organization).
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