There are no scientifically proven ways of preventing anaphylactic shock in people suffering from peanut allergy right now. But two new therapies look set to hit the market at around the same time, with both DBV Technologies and Aimmune planning regulatory filings in 2018.
DBV is in the lead with its Viaskin Peanut patch, with data from two phase III trials expected in the second half of this year. But Aimmune’s oral candidate, AR101, is not too far behind, and if both should succeed a tasty battle awaits (see table below).
The purpose of these therapies “isn’t for patients to be able eat a bowl of peanuts or a packet of M&Ms”, DBV’s chief operating officer, David Schilansky, told EP Vantage. “It’s to lower the risk of these patients having a severe reaction in case of accidental exposure.” And DBV believes that it has shown it can do this, at least in phase II.
Both groups presented results at the American Academy of Allergy, Asthma & Immunology (AAAAI) meeting in Atlanta this week, but these were incremental: DBV reported more detailed three-year results from the Olfus Vipes study, which it had already toplined in October; while Aimmune reported phase II adherence results and phase III screening data with AR101.
More important will be pivotal data, which should be available for both projects by the end of this year. DBV expects results from the Pepites and real-world Realise trials in the second half, while Aimmune’s Palisade study has a primary completion date of November 2017, according to Clinicaltrials.gov.
However, Aimmune has not yet started its real-world Ramses trial, which is slated to begin in the second quarter. The company says its planned 2018 BLA filing will be based on “at least 600 patients” in Palisade, Ramses and Arc004, a Palisade rollover study.
The initial approvals look likely to come in patients over four years old, as this is the population enrolled in the pivotal trials of both projects. But DBV is already planning expansion into a broader group, with its Epitope study in children aged one to three slated to start in the first half of this year, as well as a trial in adolescents that should begin next year.
“If successful there will be a label extension,” said Mr Schilansky.
|Viaskin Peanut||DBV Technologies||Oflus Vipes: NCT01955109||3-yr data reported|
|Pepites: NCT02636699||H2 2017|
|Realise: NCT02916446||H2 2017|
|Epitope (aged 1-3): No ID||To start H1 2017|
|Adolescent trial: No ID||To start 2018|
|AR101||Aimmune||Palisade: NCT02635776||Nov 2017|
|Arc004: NCT02993107||Apr 2020|
|Ramses: No ID||To start Q2 2017|
EvaluatePharma sellside consensus has Viaskin Peanut coming out on top, putting 2022 sales at $781m; there are currently no forecasts for AR101.
However, getting approval might just be the beginning of the battle. Neither company’s pivotal trial evaluates measures of anaphylactic shock, for example hospitalisations or Epipen use, which will surely be of interest to payers.
Mr Schilansky seemed unconcerned, saying: “Given the burden of peanut allergy and the pharmacoeconomics of food allergy, which is such a problem in the US, we do think it should be reimbursed.”
The company does not, however, intend to look specifically at pharmacoeconomic outcomes, he added. “It is not in the plans right now, but we do look very closely at quality of life and other key performance indicators.”
Assuming that this will not be a hurdle to reimbursement, DBV plans to market Viaskin Peanut alone in the US and Europe. “There are only around 5,000 allergists in the US, so you only need a fairly limited sales force, which is within our reach. We’re in good shape in the US; we already have 20-25 commercial employees. We’re also building that infrastructure in Europe.”
DBV already has one eye on the future, and hopes that approval for Viaskin Peanut will not only give it its first commercial product but also validate its epicutaneous immunotherapy platform, which delivers allergens through the skin.
Next up is Viaskin Milk, which is in two phase II trials: one in children with cow’s milk allergy, and the other in eosinophilic oesophagitis, an orphan disease commonly triggered by milk. The company also has a vaccine for whooping cough in phase I, and an egg allergy project that it hopes to move into the clinic in the next couple of years.
But DBV’s first and arguably biggest test lies in getting Viaskin Peanut approved and paid for. With Aimmune hot on its heels, the next year will be crucial.