Vir-7831 experimental monoclonal antibody demonstrated 85% reduction in hospitalization or death in Covid-19 patients adults at high risk of hospitalization, treated early with the drug candidate alone. The American announced it For Biotechnology and the British GlaxoSmithKline (Gsk), informing that an independent data monitoring committee (Idmc) has recommended that the phase 3 study ‘Comet-Ice’ be stopped in enrollment “due to evidence of profound efficacy”.
The recommendation of the Idmc – reads a note – was based on an interim analysis of data from 583 patients recruited into the trial, which indicated “an 85% reduction in hospitalization or death in patients who received Vir-7831 monotherapy compared to placebo, the primary endpoint of the study. Vir-7831 was well tolerated. As the study remains in course and blinded with patients who continue to be followed for 24 weeks – it is specified – further results, including epidemiological and virological data, will be available once the study is completed “.
Based on the data reported, Vir and Gsk intend “apply for emergency use authorization to the US Food and Drug Administration (Fda) and apply for authorization in other countries. The data from this registration study will also form the basis for submitting an organic license (Bla) application to the FDA. “
The companies also anticipate the results of a new study presented and awaiting publication online in ‘bioRxiv’, according to which “Vir-7831 maintains activity against current and worrying circulating variants of Sars-CoV-2, including variants from the United Kingdom, South Africa and Brazil, based on in vitro data from pseudotyped virus samples.Unlike other monoclonal antibodies – it is explained in the note – Vir-7831 binds to a highly conserved epitope of the Spike protein. This can make the development of resistance more difficult. “
“This exciting data with a single antibody against a conserved epitope takes us one step closer to delivering a new effective solution to patients around the world.or, “he says George Scangos, CEO of Vir. “These results, together with our pending publication of resistance data – he adds – demonstrate the potential of Vir-7831 to prevent the most serious consequences of Covid-19 and highlight its potential ability to protect against current circulating strains of the virus.”
“We are delighted that this unique monoclonal antibody was able to bring such great benefit to patients – declares Hal Barron, Scientific Director and R&D President of GSK – We look forward to the possibility of making Vir-7831 available to patients as soon as possible and to further explore its potential in other contexts. “
“Such an important fact of effectiveness is first of all great news for patients who may soon have access to this therapeutic opportunity in Italy and around the world to avoid the most serious consequences of the Covid-19 infection “, he comments Fabio Landazabal, president and CEO of Gsk Spa.
“But it is also confirmation that innovating is the best way to get out of the pandemic emergency as soon as possible and that Italy, once again, has an important role to play. In fact – highlights the manager – Vir-7831 is produced in our factory of excellence in Parma, dedicated to the introduction of new products and specialized in innovative monoclonal antibodies that it is already supplying to the whole world for the treatment of other diseases such as Lupus, Asthma severe and multiple myeloma “.