- DBV Technologies SA has secured the agreement of the Food and Drug Administration that the efficacy and safety data for the French biotech's Viaskin peanut allergy treatment would support the submission of a Biologics License Application later this year.
- Shares in DBV dropped 40% last year when a Phase 3 study fell just short of its primary objective. The markets responded favorably to Wednesday's announcement, pushing company stock up by about 20%.
- Viaskin is based on the company's epicutaneous immunotherapy technology, which delivers compounds through the skin. Next in the pipeline is Viaskin milk, with a planned clinical trial update in the first half of 2018.
The rise in DBV's stock shows investors are looking more positively at DBV and Viaskin peanut than they were last October.
"Investors had grown largely cautious since the Phase 3 PEPITES data despite favorable efficacy and safety data," said Leerink Partners analyst Dae Gon Ha in a note to clients. "Top-line results… were positive, in our view, as it demonstrated statistically significant responder rates in favor of Viaskin peanut as well as benefits on cumulative reactive dose."
Leerink assumes a 60% possibility of success with Viaskin peanut, estimating a possible market entry of 2020, and peak sales of around $2.21 billion.
Peanut allergy can be triggered by even traces of the allergen, and keeping safe involves a strict regimen of avoiding certain foods and carrying auto-injectors such as EpiPens in case of accidental exposure. Peanut allergy prevalence in children jumped 21% between 2010 and 2016, with as many as 2.5% of children in the U.S. now allergic to peanuts.
Companies moving into this space, therefore, have a large potential market, and are taking different approaches — desensitizing patients, preventing them from raising an immune response, or controlling inflammation.
Aimmune Therapeutics Inc.'s lead oral desensitization immunotherapy AR101 has completed its pivotal Phase 3 study, PALISADE, and topline data is expected this month. A follow-up study, ARC004, is ongoing, with data readout planned for third quarter of 2018. If all goes well, the company expects to file for approval in the U.S. by year's end and in the first half of 2019 in Europe.
To support this, Aimmune has completed a manufacturing facility in Florida. AR101 has breakthrough therapy designation for the desensitization of peanut-allergic children and adolescents.
Aimmune also has a collaboration with Regeneron Pharmaceuticals Inc. and Sanofi S.A. to study AR101 with adjunctive Dupixent (dupilumab), with a Phase 2 trial planned for 2018.
Other drugmakers are pursuing the space as well.
AnaptysBio Inc.'s IL-33 antibody ANB020, is in a Phase 2a trial in 20 severe adult peanut allergy patients. This is designed to block the allergic response and control inflammation, and the efficacy measure will be the dose of peanut tolerated before and after a single dose. Topline data is expected in the first quarter of 2018.
HAL Allergy Group has completed a Phase I trial with its novel subcutaneous immunotherapy product for treatment of peanut allergy, which showed safety and immunological changes.
ASP0892, a DNA vaccine licensed from Immunonomic Therapeutics Inc., is in Phase 1 with Astellas Pharma Inc. for the treatment of severe peanut allergy. This aims to protect against an allergic response to the allergen, and has Fast Track designation from the FDA.