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Gilead's ulcerative colitis antibody flunks trial

Halts trial early as preliminary data shows no evidence of efficacy

Gilead Sciences

Gilead Sciences has stopped a trial of its GS-5745 antibody in ulcerative colitis after an interim look at the data suggested there was no evidence of efficacy.

The antibody targets MMP9, an enzyme involved in the breakdown of the matrix between cells, and is also being tested for Crohn's disease and various types of cancer. Analysts at Edison have previously suggested GS-5745 could in time become a $2.5bn product across its indications.

Gilead said an analysis of the data conducted in the first 150 patients of a planned 1,600 cohort resulted in a recommendation that the trial "be terminated early due to meeting the pre-specified futility and efficacy criteria".

"Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS-5745," said the firm in a statement.

The company emphasised that a phase III study of GS-5745 in patients with gastric cancer, as well as a phase II study in patients with gastric cancer in combination with Bristol-Myers Squibb's immuno-oncology drug Opdivo (nivolumab), are continuing as planned, along with other phase II studies in moderately to severely active Crohn's disease, rheumatoid arthritis and cystic fibrosis.

In the summer it was reported that Gilead and contract research organisation (CRO) partner Quintiles were struggling to recruit patients into its phase II Crohn's disease trial.

The trial is a disappointment for Gilead but also UK-based biotech Abzena, whose antibody technology is used to produce GS-5745 as well as other candidates in Gilead's pipeline such as simtuzumab for non-alcoholic steatohepatitis (NASH).

Shares in Abzena slid in the wake of the Gilead announcement, although the UK firm was quick to point out that GS-5745 remains in testing for other indications and the drug is one of 12 drugs based on its technology that have reached the clinical testing stage. Abzena was formed by combining two companies - Polytherics and Antitope - in 2014.

Article by
Phil Taylor

22nd September 2016

From: Research



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