FDA Calendar

Thursday, June 4, 2015

Xoma: Upcoming Catalyst Event



Xoma is a late-stage biotechnology company which focuses on the development and eventual commercialization of therapeutic antibodies.  Xoma's leading commercial candidate is gevokizumab an IL-1 beta modulating antibody.  Gevokizumab bind strongly to IL-1 Beta and modulates the cellular signals that lead to inflammation.  Interleukin-1 Beta (IL-1 Beta ), also known as catabolin is a cytokine protein that is an important mediator of inflammatory response and other cellular activities. IL-1B can be over-secreted and contribute to the development of autoimmune diseases such as BDU. Xoma owns the commercial rights to in the U.S. market and Japan, with co-development partner Servier (France) holding rest-of-world development rights.

BACKGROUND

gevokizumab is undergoing Phase 3 trials called EYEGUARD. The trial is split into 3 different sections, EYEGUARD-A, EYEGUARD-B and EYEGUARD-C.  In A, it will stydy gevokizumab's ability to treat acute non-anterior non-infectious uveitis (NIU). In B, it will focus on how to prevent disease flares in patients with Behçet's uveitis.  Finally C, will focus on prevention disease flares in NIU patients who are controlled with steroids and immunosuppressants.



For further information see below: EYEGUARD Studies

https://clinicaltrials.gov/ct2/show/NCT01684345
https://clinicaltrials.gov/ct2/show/NCT01747538
https://clinicaltrials.gov/ct2/show/study/NCT0196514

Recent Updates

On May 28th Xoma announced that  Phase 3 EYEGUARD-B Study had Reached Target Exacerbation Event and primary endpoint data will be available in about 7 weeks.

Catalyst(s)

Primary endpoint data for phase 3 EYEGUARD-B (a randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis) will be released during the 1st 2 weeks of July.

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