Upcoming events: Data from Xoma’s gevokizumab and Teva’s migraine antibody

Welcome to your weekly digest of approaching regulatory and clinical readouts. Data from Xoma’s gevokizumab in uveitis caused by Behçet’s syndrome are overdue, and are expected in the coming months. Despite a series of setbacks in other indications the company is pushing on with the project's development.

Meanwhile, results from Teva’s migraine MAb LBR-101 are expected in the first quarter. LBR-101 was acquired with Labrys last year for $200m up front, and the results will determine whether it is worth the cash and on a par with the competition.

Xoma: gevokizumab

The phase III Eyeguard-B trial tests gevokizumab in Behçet’s disease uveitis, which involves inflammation of the uveal tract of the eye. The study is being run by Xoma's partner Servier in South Korea. Data were previously expected at the end of last year, but the trial had not reached the targeted number of exacerbations by the cutoff date of November and there has been little guidance on timings from Xoma.

Gevokizumab has already failed in type 2 diabetes, and work in rheumatoid arthritis remains suspended. Last year phase II trials in erosive osteoarthritis of the hand also failed (Xoma fails again and sets itself up for a bigger test, March 5, 2014).

The company has refused to give up on gevokizumab, and started Eyeguard-US, a supplemental US study in Behçet’s uveitis, last September. Two months later it also initiated a phase III trial in pyoderma gangrenosum, a rare skin disease.

Meanwhile, two larger uveitis studies, Eyeguard-A and C, are ongoing in broader patient populations but have both suffered from slow enrolment.

In December Xoma completed a $40m equity raise, likely to fund operations into the first half of 2016. While Servier is still on board for now, another clinical failure could be the final nail in the coffin for gevokizumab.

Teva: LBR-101

Teva acquired the anti-calcitonin gene-related peptide (CGRP) MAb LBR-101 when it bought Labrys last June. It paid $200m and agreed up to $625m in contingent payments, a sizeable sum for an asset that at the time had only recently entered phase II (Therapeutic focus – Teva, Lilly and Amgen square up for battle in migraine prevention, June 10, 2014).

Last year Teva completed recruitment into two phase IIb studies, in chronic and episodic migraines, in a total of 495 patients. Both assess two doses of subcutaneous LBR-101 given monthly for three months versus placebo. The primary endpoint is the mean change from baseline in the number of monthly headache days, and data are expected in the next couple of months.

LBR-101 joins anti-CGRP MAb candidates from Amgen, Lilly and Alder Biopharmaceuticals. Lilly’s LY2951742 has already reported positive phase IIb results, while trials of Amgen’s AMG 334 should read out in the second quarter. Alder started recruiting patients into a phase IIb trial testing its ALD403 last November.

Project Study Trial ID
Gevokizumab Eyeguard-A
(Pyoderma gangrenosum)
LBR-101 (Episodic migraine)
(Chronic migraine)

To contact the writer of this story email Joanne Fagg in London at [email protected] or follow @JoEPVantage on Twitter

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