AstraZeneca has announced that the Phase III SUPERNOVA clinical trial of its sipavibart (formerly AZD3152) met the primary endpoints in preventing Covid-19 among immunocompromised individuals.
A long-acting antibody, sipavibart was assessed in the trial as Covid-19 pre-exposure prophylaxis (prevention).
AstraZeneca licenced the rights to sipavibart from RQ Biotechnology in May 2022.
The randomised, global, double-blind, placebo-controlled trial was conducted across 197 sites in the US, UK, EU, and Asia.
It evaluated the efficacy and safety of sipavibart versus control (tixagevimab / cilgavimab or placebo) for Covid-19 prevention.
Trial subjects aged 12 years and above were given a 300mg intramuscular dose of sipavibart or a comparator.
A follow-up dose was administered around six months later.
According to the findings, sipavibart demonstrated to offer a statistically significant decline in the symptomatic Covid-19 occurrence.
The trial met both primary endpoints including the relative symptomatic disease risk reduction and the reduction of infections caused by variants not containing the F456L mutation.
SUPERNOVA is the only large Phase III trial to provide efficacy data in immunocompromised patients against recent variants.
The treatment was found to be well tolerated with adverse events balanced between the control and sipavibart groups.
The company is currently engaging with regulatory authorities to discuss potential authorisation or approval pathways for sipavibart based on these findings.
AstraZeneca vaccines and immune therapies executive vice-president Iskra Reic said: “Immunocompromised patients currently have limited or no options for Covid-19 protection and continue to face a significant burden of disease, despite often being fully vaccinated.
“Sipavibart has the potential to prevent Covid-19 in the immunocompromised and we will now work with regulatory authorities globally to bring sipavibart to these vulnerable patients.”
Earlier this month, the company reported positive interim data from the Phase III ECHO clinical trial of Calquence (acalabrutinib) plus standard chemoimmunotherapy for treating mantle cell lymphoma.
