Invivyd has reported positive initial data from its ongoing Phase I clinical trial of the VYD222 monoclonal antibody (mAb) candidate to prevent symptomatic Covid-19 in immunocompromised people.
The dose-ranging, placebo-controlled, blinded, randomised study is designed to assess the tolerability, pharmacokinetics, safety, and serum virus-neutralising activity of its lead investigational candidate VYD222 in 30 healthy volunteers.
Patients received three different single doses of VYD222 intravenously with 1,500mg being the lowest dose.
At day seven, patients treated with VYD222 1,500mg showed geometric mean serum neutralising titers of 3245.1 (95% CI: 1882.5, 5594.0) against Omicron XBB.1.5.
Higher VYD222 dose levels tested will further be used for greater protection from SARS-CoV-2, which may advance over time.
At all three dose levels tested, VYD222 was well-tolerated and no serious adverse events were reported.
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Follow-up of the treated patients is ongoing.
Invivyd CEO Dave Hering said: “We are very encouraged by our initial Phase I clinical trial data, including the strong serum neutralising titers against Omicron XBB.1.5, which align with our preclinical in vitro testing and are in a similar range to the titers shared at the recent VRBPAC meeting from investigational XBB-containing mRNA vaccines administered to adults who are not on immunosuppressive treatment.
“Based on previously published clinical data from randomised controlled clinical trials, we believe that monoclonal antibodies directed against the receptor binding domain of the SARS-CoV-2 spike protein offer an attractive safety profile, even at higher doses, and that strong serum neutralisation activity would be predictive of clinical benefit.
“I look forward to continuing to work with urgency to move VYD222 into a pivotal clinical trial and if authorised, to immunocompromised people in need.”
A dose selection for the pivotal trial will be designed based on the data from the Phase I study and other previous trials, including Phase II/III EVADE study of adintrevimab for the prevention of Covid-19.