HiFiBiO Therapeutics has successfully completed the first cohort of the Phase I trial (NCT04590430) of SARS-CoV-2 neutralising antibody, HFB30132A, to treat Covid-19.
HFB30132A has specific sequences identified from the B cells of a Covid-19 convalescent patient.
The antibody attaches to the viral Spike protein with high affinity and can potentially neutralise live virus infection in vitro and in vivo.
The randomised, placebo-controlled, ascending dose trial will analyse the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers.
It has three cohorts of participants who will be dosed and assessed at the Medpace Clinical Pharmacology Unit in Cincinnati, Ohio, US.
A Dose Escalation Committee will review and analyse the safety, tolerability, and PK data for each cohort.
Dosing in the second cohort will begin on analysing the safety of antibody after reviewing data from the first cohort.
No adverse events have so far been identified during the trial.
HiFiBiO Therapeutics president and CEO Liang Schweizer said: “This Phase I study is a major milestone in HiFiBiO’s evolution from a pre-clinical organisation to a clinical-stage company, and it takes us one step closer to addressing this critical pandemic situation around the world.
“We believe HFB30132A is uniquely positioned to treat patients early during infection, especially high-risk adults, to reduce instances of Covid-19 hospitalisation and complications.”
In just eight months, the company advanced its antibody from discovery to the dose of the first Phase I cohort.
HiFiBiO plans to enrol high-risk adults with asymptomatic or mild to moderate Covid-19 in Phase II/III study, which will be conducted later this year.
On obtaining primary data on HFB30132A’s safety, this trial will evaluate its efficacy.