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Home  »  Biotech and Healthcare News  »  Gilead reports positive first Phase III in RA

Gilead reports positive first Phase III in RA

12
2018
September

Gilead reports positive first Phase III in RA

Gilead Sciences, a widely held stock among biotech specialist trusts and a top 10 holding for BB Biotech (BBB, 5.1% of NAV) and Biotech Growth Trust (BIOG, 3.9%), has notched up a positive Phase III from its closely watched rheumatoid arthritis candidate filgotinib.

The company reported last night that results of “Finch-2”, the first of three Phase III trials in RA with the JAK 1 selective inhibitor, met its primary endpoint.  The study demonstrated strong efficacy – beating that of Abbvie’s upadacitinib  – and more importantly very good safety, which is likely to be the key differentiator over the approved Xeljanx (Pfizer) and Olumiant (Lilly). A cross trial comparison suggests the placebo-adjusted ACR response rates for filgotinib were 7-10 percentage points greater than those of upadacitinib for ACR20 and ACR50, two measures of efficacy, while only just a percentage point behind on ACR70, for example.

Finch-2 recruited patients with inadequate response to conventional disease modifying anti-rheumatic drugs (or DMARDS). The larger “Finch-1” and “Finch-3” studies, which recruit different types of RA patient based on their response to conventional therapies, are due to report results early next year as well as a safety trial and represent the critical path for registration. Gilead is, however, expected to use one of its priority review vouchers (which require the FDA to provide a six month review) to expedite time to market and potentially catch up some of the lag behind updacitinib. This competing drug in the same class has had four positive Phase III studies in RA this year and its registration dossier is being prepared.

The Finch-1 result follows a recent positive result in a Phase II study in ankylosing spondylitis (AS) – a form of arthritis that affects the spine.

Marten & Co has been examining the competitive landscape in JAK and related kinases for autoimmune conditions in a number of articles on Quoteddata and in particular notes the growing interest in the next generation of kinase inhibitors for autoimmune conditions, notably from the TYK2 and TYK2/Jak-1 class. Data are expected to emerge on some of these agents in studies in atopic dermatitis and psoriasis from a scientific conference later this week.

The filgotinib Phase III trials in RA are summarised in the table below.

Indication  Phase  n Design  Primary endpoint  Trial ID/name  Data
RA, inadequate response to biologic DMARDs III 449 2 doses vs placebo on top of  stable dose of permitted csDMARD(s) prop achieving ACR20 at wk 12 Finch-2  positive result
RA in combination with MTX III 1252 2 doses + MTX vs MTX alone prop achieving ACR20 at wk 24 Finch-3 Dec-18
RA inadequate response to MTX III 1759 2 doses +/- adalimumab plus MTX prop achieving ACR20 at wk12 Finch-1 Apr-19

 

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