Positive results for a mix of Eli Lilly and Company’s anti-Covid monclonal antibodies (bamlanivimab), Vir Biotechnology and GlaxoSmithKline (Vir-7831 or Gsk4182136). The three companies announce key data from the expanded Phase 2 ‘Blaze-4’ study of low-risk adult patients with mild to moderate Covid-19. The results show that “experimental bamlanivimab (Ly-CoV555) 700 mg, co-administered with Vir-7831 (also known as Gsk4182136) 500 mg – reads a joint note – demonstrated a 70% relative reduction in viral load persistently high on day 7 compared to placebo, reaching the primary endpoint “.
In addition, “bamlanivimab administered with Vir-7831 demonstrated a statistically significant reduction compared to placebo in key virological secondary endpoints in mean change from baseline to days 3, 5 and 7 in Sars-CoV-2 viral load.” Again, “there were no events for the secondary endpoint of Covid-19-related hospitalization or death by day 29 in either study arm. One patient in the treatment arm visited the emergency room for Covid-related symptoms. 19. No serious adverse events were observed with co-administration of bamlanivimab and Vir-7831 “.
The two monoclonal antibodies bind to different regions of the Sars-CoV-2 Spike protein, the pharmaceutical companies explain, noting how preclinical data suggest that “administering these two experimental antibodies together may provide protection against current SARS variants. CoV-2 resistant to bamlanivimab “.
“Persistently elevated viral load reduction is an important virological endpoint that was demonstrated in Lilly’s Phase 2 Blaze-1 study and subsequently validated in Phase 3 study, to be strongly correlated with the clinical outcome of hospitalizations and related deaths. to Covid-19 in high-risk patients. These virological data support our belief that bamlanivimab and Vir-7831 together could be a promising option for the treatment of Covid-19, “says Daniel Skovronsky, Chief Scientific Officer of American Lilly. and president of Lilly Research Laboratories.
“This virological assessment of two antibodies with distinct resistance profiles is an encouraging advance in our fight against the pandemic,” said George Scangos, Chief Executive Officer of California-based Vir.
“Vir-7831 demonstrated positive results in the Comet-Ice study and recent preclinical data suggest that Vir-7831 maintains activity against current circulating variants of concern. Now, with these exciting new data from the Blaze-4 study,” he comments. we believe Vir-7831 has an important role to play both alone and in combination with other mAbs. We look forward to continuing conversations with the FDA about Vir-7831 alone and co-administered with bamlanivimab. “
“These first data from the Blaze-4 study, together with the results from the Comet-Ice study demonstrating an 85% reduction in progression to hospitalization or death using Vir-7831 – recalls Hal Barron, Chief Scientific Officer and President R&D , Gsk – support our hypothesis that, by targeting a highly conserved epitope, Vir-7831 may help provide benefits to patients. We are continuing to work with regulatory authorities to bring Vir-7831 as monotherapy and potentially co-administered with other antibodies. monoclonal to needy patients “.
“We are pleased to continue to record positive results for the experimental anti Covid drug Vir-7831 that we produce in Parma – commented Fabio Landazabal, president and CEO of Gsk Spa – and that also in combined use confirms its effectiveness against the variants of the virus”.