- COMET-TAIL Phase III data demonstrated that intramuscular administration of sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations
- The trial enrolled participants during the Delta variant wave of the pandemic in the US
GlaxoSmithKline plc (LSE/ NYSE GSK) and Vir Biotechnology,Inc. (Vir) (Nasdaq VIR) moment blazoned caption data from the randomised,multi-centre, open- marker COMET- TAIL Phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab wasnon-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate COVID-19 in high- threat,non-hospitalised grown-ups and adolescents (12 times of age and aged).
The COMET- TAIL Phase III trial was designed to estimate the efficacity, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high- threat cases up to seven days after symptom onset. In the IM administration (500 mg) arm of the trial, there was a2.7 rate of progression to hospitalisation for further than 24 hours or death through Day 29 of the trial, compared to1.3 in the IV administration arm ( also 500 mg). The acclimated difference between the IM and IV arms of the trial was1.07 with a 95 confidence interval (CI) of-1.25 to3.39. The upper bound of the 95 CI is within the destined3.5non-inferiority periphery set for the trial’s primary endpoint in discussion with the US Food and Drug Administration (FDA).
In addition, there were low rates of serious adverse events and Grade 3-4 adverse events (≤ 1 in both arms, for both measures) observed in the caption data.
The companies plan to progress nonsupervisory cessions encyclopedically, including ongoing conversations with the FDA regarding the being Exigency Use Authorization for sotrovimab.
Dr Hal Barron, Chief Scientific Officer and President, said “ I’m pleased that moment’s results demonstrated analogous efficacity for sotrovimab when fitted directly into the muscle compared to administered intravenously, potentially offering a more accessible option for cases. We look forward to working with nonsupervisory authorities to help make this new option available to applicable cases with COVID-19.”
George Scangos,Ph.D., principal administrative officer of Vir, said “ This trial was conducted during the height of rotation of the Delta variant, with significant registration in Florida – a hot spot for this particular variant and where hospitalisation rates equaled further than 10 percent of verified cases. We designed sotrovimab to stand up to the variants that we anticipated would do, and these data demonstrate that sotrovimab administered via IV or IM could prove important in the fight against COVID-19 following authorisation. As we approach the third time of the epidemic, we can anticipate that multiple treatment options will continue to be demanded, particularly for high- threat cases with complex health requirements.”
Moment’s update follows adverts in the first half of 2021 regarding the COMET-ICE Phase III trial, which delved IV infusion of sotrovimab in grown-ups with mild or moderate COVID-19 at high- threat of progression to severe complaint. The final COMET-ICE trial results in the full study population of 1057 actors, demonstrated a 79 reduction in hospitalisation and death at Day 29 vs placebo.
Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 that’s participated with SARS-CoV-1 (the contagion that causes SARS), indicating that the epitope is largely conserved, which may make it more delicate for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend ™ technology, has also been designed to achieve high attention in the lungs to insure optimal penetration into airway apkins affected by SARS-CoV-2 and to have an extended half- life.
Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organisation, plus others, including, but not limited to, Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).
About the sotrovimab clinical development programme
COMET-ICE a Phase III,multi-centre, double-eyeless, placebo- controlled trial delved intravenous (IV) infusion of sotrovimab in grown-ups with mild-to-moderate COVID-19 at high- threat of progression to severe complaint, who aren’t hospitalised and not taking oxygen. The final COMET-ICE trial results in the full trial population of actors demonstrated a 79 reduction ( acclimated relative threat reduction).