Benzinga - by Vandana Singh, Benzinga Editor.
Thursday, AstraZeneca Plc (NASDAQ:AZN) released high-level results from the SUPERNOVA Phase 3 COVID-19 pre-exposure prophylaxis (prevention) trial.
The study showed AstraZeneca's sipavibart (formerly AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control (tixagevimab/cilgavimab or placebo) in immunocompromised patients.
The trial met both dual primary endpoints: Relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.
SUPERNOVA demonstrated the potential benefit of sipavibart in an evolving variant landscape.
Immunocompromised people include those with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, patients receiving B-cell depleting therapy within the past year, and those taking immunosuppressive medications, AstraZeneca said.
Despite accounting for approximately 4% of the population, immunocompromised patients make up about 25% of COVID-19 hospitalizations, ICU admissions, and deaths, even after multiple doses of COVID-19 vaccines.
Sipavibart was well tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms.
The data will be presented at a forthcoming medical meeting. AstraZeneca is in dialogue with regulatory authorities on potential authorization or approval pathways.
AstraZeneca licensed Sipavibart in May 2022 from RQ Biotechnology.
Recently, AstraZeneca declared a worldwide cessation of its COVID-19 vaccine, Vaxzevria, due to an "excess of updated vaccines."
Last month, AstraZeneca, while contesting the claims alleging its vaccine caused death and serious injury, has acknowledged in court documents that its vaccine can, in rare instances, cause thrombosis with Thrombocytopenia Syndrome (TTS), a condition characterized by blood clots and low blood platelet counts.
Price Action: AZN shares are down 0.04% at $76.94 at the last check on Thursday.
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