DBV gets peanut allergy therapy programme back on track

Shares in DBV Technologies have shot up after it presented positive clinical trial results with an immunotherapy for peanut allergy that was rejected by the FDA several years ago.

The Paris, France-listed biotech said the phase 3 VITESSE study met its main efficacy objective, with 46.6% of peanut-allergic children aged 4 to 7 who were treated with the patch-based Viaskin Peanut product meeting the criteria for a clinical response after 12 months, compared to 14.8% of a placebo group.

DBV's first attempt to secure FDA approval for the patch-based immunotherapy product was withdrawn in 2018, and the regulator turned down the next one in 2020 due to concerns about efficacy related to the adhesion of the patch to the skin.

The new study has been carried out with a redesigned patch formulation. Armed with the new data, DBV is now moving forward with plans for a biologics license application (BLA) for Viaskin Peanut in the US in the first half of next year.

Shares in the company rose more than 35% on the strength of the data, which could put DBV on track to bring the immunotherapy to market in the US as the first alternative to Stallergenes Greer's Palforzia, which has had sluggish sales due to cumbersome administration protocols, including biweekly clinic visits over several months.

Palforzia was originally marketed by food giant Nestle, which acquired it along with Aimmune Therapeutics in 2020. It subsequently sold the product on to Stallergenes Greer, but the latter company recently said it plans to remove it from the market altogether next year after failing to build a sustainable business.

That will leave children with peanut allergy no recourse but to rely on strict measures to avoid exposure – unless DBV can successfully bring Viaskin Peanut to market.

"Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance," said David Fleischer, professor of paediatrics at Children's Hospital Colorado in the US, who was the principal investigator of the VITESSE study.

"The levels of desensitisation achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into paediatric care," he added.

Analysts have previously predicted that an effective, user-friendly peanut allergy product could eventually become a $1 billion-plus product, given there are around 1.8 million people with peanut allergy in the US, around a million of whom are children.

Photo by Fidias Cervantes on Unsplash