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Third positive phase III trial for Lilly/Incyte's baricitinib

Baricitinib beats methotrexate in rheumatoid arthritis
Eli Lilly

Eli Lilly and Incyte's rheumatoid arthritis (RA) therapy baricitinib has outperformed methotrexate in a phase III clinical trial, the third of four studies in its pivotal trials programme.

Top-line results from the BEGIN trial in patients with moderately-to-severely active (RA) exceeded its primary objective of showing non-inferiority of baricitinib to methotrexate based on an ACR20 response rate (20% improvement in signs and symptoms of RA) after 24 weeks of treatment.

As it turned out, baricitinib was found to be superior to methotrexate based on ACR20 response and the drug was no more likely to cause serious side effects such as infections, according to Lilly.

Baricitinib is a once-daily, oral Janus kinase (JAK) inhibitor and if approved for marketing would compete with Pfizer's Xeljanz (tofacitinib), which achieved sales of $224m in the first six months of the year and is the only JAK inhibitor on the market to treat RA. Another Incyte developed JAK inhibitor - Novartis' Jakafi (ruxolitinib) - is on the market for haematological cancers.

Earlier this year, Lilly and Incyte reported data from two earlier studies which were both positive. The BEACON trial compared baricitinib to placebo on a background of traditional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, in patients who had already failed treatment with an injectable TNF blocker, the most widely-used biologic therapies for RA.

That was followed by BUILD, which had a similar design but included patients who had not received TNF inhibitor therapy. The fourth trial - BEAM - is a head-to-head comparison with AbbVie's TNF-targeting antibody Humira (adalimumab) and is due to report data in December.

Assuming the latter shows that baricitinib is equivalent in efficacy and safety, the drug is on course for filing before the end of the year.

"If the clinical data is showing that once a day pill can have an efficacy safety ratio that is very much in line with what you expect from a TNF injectable …why not use a pill if you can," asked Incyte chief executive Herve Hoppenot at the Morgan Stanley conference earlier this month.

If they achieve the intended filing schedule, Incyte and Lilly will be on course to be the second JAK inhibitor to reach the market for RA, ahead of rivals from AbbVie and Galapagos. AbbVie has just dissolved an alliance and elected to take its own drug ABT-494 into phase III trials, while Galapagos has pledged to advance its filgotinib candidate independently.

All of the drugs have slightly different activity profiles against JAK subtypes, and rheumatologists are interested to see if this will translate into any difference in clinical profiles in phase III. 

If approved, Incyte would receive a royalty of between 20% and 29% on net sales of baricitinib on a worldwide basis.

Article by
Phil Taylor

30th September 2015

From: Research



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