Date: 2015-06-03
Type of information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Vectura (UK) UCB Pharma (Belgium)
Product: VR942
Action
mechanism: immunomodulating agent.
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: UK
Trial
details: This randomised, double-blind, placebo-controlled, dose-escalation study evaluates the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2). Three dose levels were delivered in an ascending fashion to a total of 45 patients who remained in the clinic until Day 14 and returned for a final follow-up visit at Day 28. In addition to safety, PK and immunogenicity evaluation multiple daily pharmacodynamic measurements were performed. (NCT02473939)
Latest
news: * On June 3, 2016, Vectura announced the successful completion of a Phase I clinical study (VR942-1-001) evaluating their inhaled biologic immunomodulatory product VR942. The study was successfully completed and met its primary objective of evaluating the safety and tolerability of once daily VR942 single or repeat doses, administered as a dry powder via inhalation, in healthy volunteers and mild asthmatics respectively. In this study, VR942 was safe and well tolerated at pharmacologically active doses. In addition, the investigation did not reveal any immunogenicity concerns and pharmacokinetic analysis demonstrated undetectable systemic exposure consistent with the mode of administration. Outcomes from the pharmacodynamic assessment of once daily doses to mild asthmatics over a 10-day in-clinic period met a priori study success criteria. Rapid and durable attenuation of anti-inflammatory biomarker concentrations were statistically significantly greater for VR942 compared to placebo, indicating pharmacological engagement of a disease relevant target. The generated data package supports the continued development of VR942 in severe inflammatory respiratory disease and progression of Phase II preparative activities. Detailed study outcomes will be presented at a future scientific conference. * On June 4, 2015, Vectura, which specialises in the development of products for the treatment of airways-related diseases, announces that, following the successful completion of a number of pre-clinical studies, enrolment has commenced into a Phase I clinical study (VR942-1-001) in healthy volunteers and patients with asthma. In September 2013, Vectura and UCB announced that they had entered into a collaboration for the development of an innovative inhaled biologic immunomodulatory product ("VR942") in the area of severe inflammatory respiratory disease. The partnership, leveraging Vectura's dry powder inhaler/formulation and clinical/regulatory experience with UCB's biologics and immunology expertise, will focus upon the development of VR942 to completion of Phase II clinical proof-of-concept.
