DBV Technologies is a biopharmaceutical company that focuses on developing treatments for food allergies. The company is based in Montrouge, France, and is known for its innovative approach to treating food allergies through the use of its proprietary Viaskin technology. This technology involves delivering allergens through the skin, rather than through oral consumption, to desensitize patients to the allergens and reduce the likelihood of allergic reaction.
Viaskin Peanut, Viaskin Milk, and Viaskin Egg make up DBVT's line of allergic treatment products.
The emergence of the infringing allergen into the bloodstream could lead to serious or life-threatening allergies, among other anaphylactic shocks. Therefore, this technology treats patients, like children and infants experiencing severe food allergies, as safety is a top priority for these patients.
In 2002, Dr. Pierre-Henri Benhamou, engineer Bertrand Dupont from Paris' Arts & Métiers ParisTech, and Professor Christophe Dupont formed DBV Technologies. Together they funded the inaugural start-up budget. However, between December 2003 and January 2011, DBV Technologies secured venture capital worth about €40 million. Again, NYSE Euronext's initial public offering in March 2012 brought around €40.5 million (Euros). Currently, Pascal Wotling is the Chief Technical Operations Officer, and Daniel Tassé is the Chief Quality Officer.
In August 2020, the FDA sent a Complete Response Letter (CRL) that aligns with DBVT's Biologics License Application (BLA) for Viaskin Peanut (DBV712 250 g). An experimental, non-invasive, once-daily epicutaneous patch to manage peanut allergy among children aged 4 to 11 years.
DBVT addressed the requirement for patch revisions, which was the FDA's primary concern raised in the CRL, as a viable remedy. The FDA consented to DBV's assertion that a revised Viaskin Peanut patch may be a suitable strategy, so they did not regard it as a new product element. However, this was conditional as the patch's occlusion chamber and the peanut protein dose of 250 g (roughly 1/1000 of a peanut) stayed the same and worked as intended.
Once again, DBV notified the FDA of its intention to start a pivotal Phase 3 clinical research in the targeted age group for a modified Viaskin Peanut patch, VITESSE, in the 4th quarter of 2021. The existing Viaskin Peanut patch is rectangular, whereas the modified patch is circular and is about 50% bigger.
Notably, the EPITOPE research included the square-shaped current VP patch. For upcoming regulatory or BLA developments using the EPITOPE data, DBV may continue using the current VP patch.
The FDA asked for adjustments to the VITESSE guidelines in the Partial Clinical Hold (PCH) letter, such as:
After the FDA imposed a hold in September, it verified DBV has successfully resolved each clinical hold problem mentioned in the PCH letter before dropping the PCH. This made DBV Technologies' (DBVT -2.14%) stock rise by 19% only after it disclosed that the FDA partially withdrew a clinical hold on late-stage clinical studies.
DBV intends to start different safety research with about 275 extra participants. However, the added safety research may not influence the company's financial runway estimate. DBV also expects to screen VITESSE patients in the initial quarter of 2023, with the last screening in the second half of 2024 and findings expected in the third quarter of 2025.
At Brown Investors, we seek to expand financial literacy reach, while also providing investment tools and portfolio management for generational wealth creation.
Contact us today for more details on how to become a member and let us help you find a promising investment.