National Treasure, Redhill's COVID-19 Treatment 'Opaganib' Reduces Mortality by 70%... FDA Approval Application Planned

[Asia Economy Reporter Ji-hwan Park] RedHill Biopharma, a US-Israeli biotechnology company in which Kookbo, a KOSPI-listed company, has acquired shares, announced two preliminary designated analysis results of the oral COVID-19 treatment Opaganib currently under development as of the 8th, along with updates on progress with regulatory agencies in various countries.

According to the first preliminary designated analysis results, Opaganib significantly reduced the mortality rate compared to the control group of patients who received standard treatment (remdesivir + corticosteroids). This analysis, conducted on all patients in the Phase 2/3 study, showed a mortality rate of 6.98% (n=3/43) in the Opaganib group versus 23.4% (n=11/47) in the control group up to 42 days after administration, representing a 70.2% reduction in mortality.

The second preliminary designated analysis results indicated that Opaganib reduced recovery time by 34%. The time to recovery (based on WHO Ordinal Scale 1) within 14 days after administration was 37.4% (n=86/230) in the Opaganib group and 27.9% (n=65/233) in the control group, showing a clear impact on recovery time, according to RedHill.

RedHill stated that since the fourth quarter of 2021, it has begun submitting data related to the oral COVID-19 moderate-to-severe treatment Opaganib to the US, Europe, the UK, and other countries, and is currently in discussions with several countries. They have received feedback from regulatory agencies in various countries and plan to apply for emergency use authorization in the first half of 2022.

Recently, as Omicron has become the dominant strain domestically and the total number of confirmed cases exceeds 30,000 daily, the number of severe patients has decreased while the number of moderate patients in the Opaganib treatment group is increasing. In the first week of February, the weekly average bed occupancy rate showed a 0.5 percentage point decrease in severe beds compared to the previous week, while moderate beds increased by 6.1%, and beds in infectious disease-dedicated hospitals rose by 8.0 percentage points.

A Kookbo official said, "We are in detailed discussions regarding the license agreement for Opaganib and aim to proceed within the first quarter of this year," adding, "Starting with this license agreement, Kookbo will actively target the COVID-19 treatment market."

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