Phase III setback for Shionogi’s COVID-19 pill Xocova could imperil US filing plans
13 May 2024
Phase 3Clinical ResultDrug ApprovalEmergency Use Authorization
Just over two months after securing full approval in Japan, Shionogi on Monday said its oral COVID-19 antiviral Xocova (ensitrelvir fumaric acid) failed to hit the main goal of time-to-symptom resolution in a global Phase III study, potentially jeopardising the company’s plans for a US regulatory filing next year.
The SCORPIO-HR trial enrolled 2093 non-hospitalised patients with mild-to-moderate COVID-19 from North America, South America, Europe, Africa and Asia during the Omicron-predominant era, irrespective of past infection. The participants, most of whom were vaccinated, were randomised to receive Xocova or placebo within three days of symptom onset for a period of five days. The primary endpoint was time-to-sustained symptom resolution, defined as two consecutive days of complete resolution of 15 common COVID-19 symptoms during a 29-day follow-up.
Numerical reduction misses significance
Results showed that while Xocova demonstrated a numerical reduction in the primary endpoint compared with placebo, the difference lacked statistical significance. However, a predetermined supportive analysis encompassing six symptoms — mirroring the earlier Phase III SCORPIO-SR study of Xocova in a narrower group of Asian participants — revealed a significant difference in symptom resolution versus placebo.
The company also noted that the drug significantly lowered viral RNA levels and culture positivity compared with placebo, without evidence of symptomatic viral rebound, consistent with SCORPIO-SR findings. No deaths were reported in either arm and COVID-19-related hospitalisations were minimal in both arms. Detailed findings are likely to be presented at a forthcoming conference.
“These top-line results, while mixed, confirm an antiviral effect and add to the existing clinical data and real-world evidence that we have seen for ensitrelvir in Asia,” commented Simon Portsmouth, head of clinical development at Shionogi, adding that the company would continue to engage with regulatory agencies to chart the antiviral’s path forward.
Xocova received emergency clearance in Japan for treating COVID-19 in November 2022 based on the SCORPIO-SR results, and was subsequently granted approval by Singapore in 2023.
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