DBVT has announced that the last patient visit has been completed in the Company’s Phase III VITESSE clinical trial of the VIASKIN Peanut patch in peanut allergic children aged 4-7 years.
With the completion of the double-blind, placebo-controlled treatment phase of the study, DBV remains on track to announce topline data from VITESSE in the fourth quarter of this year.
"Last patient last visit represents a very important milestone for DBV, as it brings us one step closer to the potential of bringing this treatment option to peanut allergic children, their physicians and caregivers, if approved,” stated Daniel Tassé, CEO of DBV Technologies.
"We’re grateful to the investigators, internal teams and most importantly, patients and caregivers, for their time and commitment to this study."
"We look forward to sharing topline results this quarter."
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need.
DBV is currently focused on investigating the use of its proprietary VIASKIN patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterised by a range of symptoms varying in severity from mild to life-threatening anaphylaxis.
Through epicutaneous immunotherapy (EPIT), the VIASKIN patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin.
EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitised to allergens by leveraging the skin’s immune-tolerising properties.
The VITESSE Phase III trial in peanut-allergic children ages 4-7 is a 12-month study evaluating the efficacy and safety of the VIASKIN Peanut patch in 654 subjects (randomised 2:1), representing individuals across 86 sites in the US, Canada, Europe, the UK and Australia.
VITESSE is currently the largest treatment intervention study in peanut allergy.