Erste Ergebnisse der Ph I Dosis-Eskalationsstudie mit VLP Erdnuss in gesunden Probanden

Introduction Virus-like particle (VLP) Peanut is a novel hypoallergenic subcutaneous therapeutic vaccine candidate to treat peanut allergy. The first-in-human Phase I trial (PROTECT) has been carried out in the US to evaluate safety & tolerability of VLP Peanut in healthy & peanut allergic subjects. Method 8 healthy adults with confirmed absence of allergy to peanut or any other food in clinical history, negative skin prick test (SPT) to whole peanut extract (WPE) (≤2mm), negative WPE specific IgE (Results VLP Peanut subcutaneous doses, which were escalated 50-fold and administered to healthy adults, were safe & well tolerated. No systemic AEs were reported. Mild local AEs observed in 7 subjects were related to pain, redness and tenderness at injection site. 2 subjects reported mild symptoms (headache, fatigue, muscles aches). Vital signs, spirometry and safety laboratory assessments were within normal ranges. Discussion Safety & tolerability results for the first 6 escalating subcutaneous injections of VLP Peanut strongly support a benign safety profile of the VLP component of VLP Peanut in healthy subjects. Higher escalating cumulative subcutaneous doses of VLP Peanut are currently evaluated and dose escalation is underway in peanut allergic subjects to inform the dose range to be evaluated in Phase II.

Die vorliegende klinische Studie wurde finanziert durch Allergy Therapeutics, Worthing, Vereinigtes Königreich