Immunemed Receives Approval for Phase 3 Clinical Trial Plan of COVID-19 Treatment Candidate 'Bupiralimab' in Indonesia

[Asia Economy Reporter Lee Gwan-joo] Immuned announced on the 29th that it has received approval from the Indonesian Food and Drug Authority (BPOM) for the Phase 3 clinical trial plan (IND) of burfiralimab as a COVID-19 treatment.

This Phase 3 clinical trial will be conducted in multiple countries, targeting 680 severe COVID-19 patients. 50% of the participants will receive burfiralimab combined with standard treatment, while the remaining 50% will receive a placebo combined with standard treatment. After a total of three administrations and up to 60 days of observation, the efficacy and safety of burfiralimab combination therapy compared to placebo will be evaluated.

Immuned has also submitted an IND for the Phase 3 clinical trial domestically. An Immuned official stated, “Although the number of COVID-19 patients worldwide is declining, treatments for severe COVID-19 patients have not yet been developed, and deaths continue to occur,” adding, “We will complete the Phase 3 clinical trial of burfiralimab for COVID-19 as soon as possible to enable market supply.”

This content was produced with the assistance of AI translation services.