Upcoming events – Sarilumab’s date with the FDA and more peanut data from DBV

Analysis

Welcome to your weekly digest of approaching regulatory and clinical readouts. By the end of next week the FDA will decide on Regeneron’s sarilumab, an IL-6 targeting MAb that looks set to reach the rheumatoid arthritis market before J&J’s sirukumab, but will be entering a crowded space with biosimilars on the horizon.

And before the year is out topline three-year phase II data are expected from DBV’s Viaskin Peanut. The allergy project, which is unpartnered, has generated encouraging results at previous time points, and when crucial phase III data are reported next year, it could garner interest from other companies.

Race to market

With a decision expected by October 28 sarilumab is expected to become the newest IL-6 MAb on the US market.

The Regeneron asset, partnered with Sanofi, is trying to make headway in a crowded rheumatoid arthritis space, having already outperformed the RA stalwart Humira in a head-to-head trial called Saril-RA-Monarch, though these data are not said to be part of the US submission. An EU decision is expected by the middle of next year.

Competition looms in the form of Johnson & Johnson and GlaxoSmithKline's sirukumab, another IL-6-targeting MAb, which completed a US filing last month. Sirukumab has also reported positive topline data against Humira, and detailed results of the Sirround-H trial are expected at the ACR meeting in November.

EvaluatePharma's sellside consensus pegs sirukumab as the bigger seller, with 2022 revenues of $1.1bn versus $837m for sarilumab. However, sirukumab reported less than stellar results at Eular in June, and if full details of its study against Humira do not stand out forecasts could be revised (Eular – Sirukumab’s best-in-class promise fades, June 9, 2016).

Then there is the threat from biosimilars. Humira copycats could enter the market next year, and versions of Actemra, the only currently approved IL-6 targeting product, by 2019, so sarilumab needs to make the most of its advantage.

Three-year data

Meanwhile, DBV's Olfus-Vipes is an open-label extension of the phase IIb Vipes trial for treating peanut allergies. All patients, including those previously on placebo, were crossed over to 250µg of Viaskin Peanut, a patch that delivers allergens to the skin.

Olfus-Vipes includes patients aged 7 to 56, and its primary endpoint is an increase in the threshold dose of peanut protein assessed by double-blind, placebo-controlled food challenges.

36-month data are expected before the end of the year, while 38-month results, where patients are removed from Viaskin Peanut for two months to test for a sustainable response, will come in the first quarter of 2017. Full readout is expected at the American Academy of Allergy, Asthma & Immunology meeting in March.

In the Vipes trial 50% of patients given 250µg responded, increasing their tolerance to the challenge according to prespecified criteria, at 12 months versus 25% of those on placebo. Although the trial was deemed a success the placebo response was relatively high, and there was a lack of activity in older patients (AAAAI: DBV’s peanut data need little buttering up, February 25, 2015).

Two-year results from Olfus-Vipes also favoured earlier treatment, showing an 80% response rate in patients aged 6-11. The upcoming data will determine whether responder rates continue to increase and whether patient compliance remains high.

Looking further ahead two phase III trials are expected to report in the second half of next year. The pivotal Pepites trial is in over 350 children aged 4-11, with a primary endpoint based on a responder analysis. And Realise will provide additional safety data, and is also recruiting more severe patients – those with a history of anaphylaxis, which could expand the market for DBV.

According to consensus from EvaluatePharma 2022 sales of Viaskin Peanut are forecast to reach $568m. It has an NPV of $1.1bn, 63% the company’s market cap, making it a potentially valuable unpartnered asset. While the company has previously said it did not need a sales partner one could emerge on positive data.

Project Study Trial ID
Sarilumab Saril-RA-Monarch NCT02332590
Sirukumab Sirround-H NCT02019472
Viaskin Peanut Vipes
Olfus-Vipes
Pepites
Realise
NCT01675882
NCT01955109
NCT02636699
NCT02916446

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @JoEPVantage on Twitter

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