egeltjemetstekel schreef op 23 augustus 2016 15:08:
www.fiercebiotech.com/biotech/gilead-...Gilead, Galapagos start PhIII of RA drug, 8 months after AbbVie began rival program
by Nick Paul Taylor | Aug 23, 2016 6:48am
Gilead ($GILD) and Galapagos ($GLPG) have hit go on a Phase III trial program for their rheumatoid arthritis drug, filgotinib. The initiation of the three-study program comes eight months after AbbVie ($ABBV), which walked away from filgotinib, began the first of five Phase III trials of its rival JAK1 inhibitor ABT-494.
Back when Galapagos first learnt of AbbVie’s rejection 11 months ago, it expected to start a Phase III trial of filgotinib early in 2016. Ultimately, while Galapagos met its goal of having a new partner in place by the end of 2015, it has taken longer than expected initially to get the Phase III study up and running. In the interim, AbbVie has stolen a march on its ex-partner, benefiting from the upheaval it caused by gaining an eight month head start in Phase III.
All five of AbbVie’s Phase III trials of ABT-494 are listed as recruiting on ClinicalTrials.gov. The first got underway in January. Gilead and Galapagos, in contrast, have only just started enrolling patients in one of their three planned Phase III trials, FINCH 2. The partners are yet to add details of the other Phase III trials to ClinicalTrials.gov, but have disclosed outlines of their designs in a statement to reveal the start of the program.
The challenge now for Gilead and Galapagos is to work through the Phase III trials as fast as possible and, in doing, stop AbbVie from extending its lead. Clinical trial designs could act as a barrier to this goal. FINCH 1 is both longer and larger than the equivalent trial of ABT-494, SELECT-COMPARE. Both FINCH 1 and SELECT-COMPARE are giving JAK1 inhibitors in combination with methotrexate (MTX) to patients who had inadequate responses to MTX alone.
SELECT-COMPARE is enrolling 1,500 patients and assessing them over 48 weeks. FINCH 1 will recruit 1,650 participants and follow them for 52 weeks. While FINCH 1 is longer, the timing for its primary endpoint is the same as for SELECT-COMPARE. Both trials will be defined by the performance against ACR20 at week 12. FINCH 3, a trial in MTX-naïve patients, is also larger than the equivalent AbbVie trial. AbbVie is aiming to enroll 19% fewer participants in its MTX-naïve trial.
If Gilead and Galapagos can keep AbbVie in sight throughout the Phase III program, such differences may be irrelevant in the long term. But, if AbbVie can use its current lead to bring ABT-494 to market well before filgotinib, Gilead and Galapagos could end up with a good drug that struggles to capture market share.
AbbVie has experienced this in trying, with limited success, to take on Gilead’s juggernaut hepatitis C franchise. But, equally, AbbVie’s experience with Humira has shown it is possible to come from behind.
- read the release
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