Clinical stage biotechnology firm Vega Therapeutics has commenced its clinical trial programme for VGA039 to treat von Willebrand disease (VWD).
The company has dosed the first participant in the multinational Phase I clinical trial of the first-in-class antibody therapy, VGA039.
The trial has been designed for evaluating the tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and safety of VGA039 after single IV or SC dose administration in healthy participants and single SC dose administration in VWD patients.
It is being conducted after the receipt of the investigational new drug application (IND) approval by the US Food and Drug Administration (FDA) and clinical trial application (CTA) approval in Europe.
The company stated that the trial will commence enrolment of healthy volunteers and will expand to include VWD patients.
The first-in-human trial comprise Part 1 and Part 2, based on the subject population.
Part 1 is a placebo-controlled, double-blind, randomised, single ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to eight cohorts, and Part 2 is an open-label, SAD of SC VGA039 in up to four cohorts.
Vega Therapeutics chief medical officer Gary Patou said: “We are excited to advance VGA039 into the clinic as the first purpose-built antibody therapy for VWD, representing a new approach with the potential to reduce the treatment burden for these patients.
“It is our goal at Vega to enable better therapies for patients with VWD, and we are excited to have taken the first step by dosing our first subject.”
The company intends to enrol the Phase I clinical trial for VGA039 at clinical trial sites across the US as well as other countries.