Xoma said today the monoclonal antibody gevokizumab it is co-developing with Servier has failed the Phase III EYEGUARD-B trial in patients with Behçet's disease uveitis.

Gevokizumab missed its primary endpoint of time to first acute ocular exacerbation in EYEGUARD-B, which was run by Servier, Xoma said.

“Although the study did not achieve its main objective, we did see signals of drug activity such as preserved visual acuity, less severe ocular exacerbations, and a reduced incidence of reported macular edema in patients treated with gevokizumab,” Paul Rubin, M.D., Xoma’s svp, research and development and CMO, said in a statement.

He added that Xoma will continue to work closely with Servier and uveitis experts “to conduct a thorough analysis of the data to fully understand gevokizumab's impact on several clinically relevant endpoints.”

That data includes initial observations seen in the secondary endpoints “that are clinically important and meaningful to both clinicians and Behçet's disease uveitis patients,” added Ilknur Tugal-Tutkun, M.D., international coordinator for EYEGUARD-B and professor of ophthalmology and head, ocular immunology and uveitis service at Istanbul University, Istanbul Faculty of Medicine.

The trial’s secondary endpoints included total number of exacerbations, best corrected visual acuity, vitreous haze, retinal lesions, fundus assessments and macular edema. Gevokizumab appeared to be well tolerated in EYEGUARD-B, with comparable adverse events between gevokizumab and placebo treated groups, Xoma said.

EYEGUARD-B was intended to demonstrate the superiority of gevokizumab, compared with placebo, on top of the current standard of care in reducing the risk of Behçet's disease uveitis exacerbations and to assess the safety of gevokizumab. The study was designed to enroll patients with a history of Behçet's disease uveitis with ocular involvement of the posterior segment who had experienced a recent ocular exacerbation that was treated successfully with high doses of corticosteroids, according to Xoma.

The trial enrolled 83 patients in the core part of the study (40 on gevokizumab and 43 on placebo). Patients were randomized to either a 60 mg dose of gevokizumab or placebo administered subcutaneously once monthly, in addition to their current immunosuppressive and corticosteroid therapies. Patients were randomized when they reached the step of 20 mg/day equivalent oral prednisone and continued a standardized tapering regimen until they reached 5 mg/day during double-masked treatment.

Xoma CEO John Varian said two additional trials of gevokizumab run by the company are still recruiting patients, EYEGUARD-A and –C.

Last year Xoma halted development of gevokizumab in erosive osteoarthritis of the hand, following discouraging results in a Phase II trial.

Varian also hinted at possible cutbacks in company operations as well as a shift toward development of two pipeline compounds. One is XOMA 358, which has completed a positive Phase I trial that showed the compound down-regulating the insulin receptor, as well as potential in treating patients who experience endogenous over-production of insulin. The other compound, XOMA 089, is a late preclinical anti-TGFβ monoclonal antibody with potential in immuno-oncology and fibrosis, according to Xoma.








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