Xoma (XOMA) announced good news from Phase 3 EYEGUARD-B trial of its monoclonal antibody drug gevokizumab for Behcet’s uveitis. The study, which is sponsored by Xoma’s development partner Servier, reached its target exacerbation event as specified in the study design.
The objective of the first part of this study is to demonstrate the superiority of gevokizumab, inreducing the risk of Behcet’s disease uveitis exacerbation and assess the safety of gevokizumab. The drugs results are compared to placebo, on top of the current standard of care (immunosuppressant therapy and oral corticosteroids).
Servier will begin the process of closing the clinical database and analyzing the data from this part of the study. Servier has provided a detailed schedule of the activities it will undertake to allow the locking of the database. The primary endpoint result is expected in approximately seven weeks. The trial is ongoing and remains double-masked for the extension period of the study.
The Phase 3 EYEGUARD-B study — a randomized, double-masked, placebo-controlled study of the efficacy of Gevokizumab in the treatment of patients with Behcet’s Disease uveitis) was designed to enroll patients with a history of Behcet’s disease uveitis with ocular involvement of the posterior segment who have experienced a recent ocular exacerbation that was treated successfully with high doses of corticosteroids.
Patients were randomized to either a 60 mg dose of gevokizumab or placebo administered subcutaneously once monthly on top of their current immunosuppressive and corticosteroid therapies. The primary endpoint is the time to first acute ocular exacerbation.
Behcet’s disease: This disease is an orphan disease, which causes vasculitis (chronic inflammation of the blood vessels). Major symptoms can affect the neurological, pulmonary, gastrointestinal and cardiovascular systems. Painful ulcers in the mouth and on the genitals are hallmarks of the disease. The disease affects men and women in their twenties, thirties and forties, and it typically affects more women but is more severe in men. Behcet’s disease is referred to as the “Silk Road” disease because it is most common among people from countries along this ancient trade route, including Turkey, eastern Mediterranean countries, Japan and Korea. In the United States, an estimated 15,000 individuals have Behcet’s disease.
Behcet’s disease uveitis is one of the most severe forms of non-infectious uveitis and affects approximately 60 percent of those with Behcet’s disease. Behcet’s disease uveitis is characterized by recurrent acute attacks or exacerbation. Without immediate treatment, major exacerbation of Behcet’s uveitis may lead to retinal detachment, vitreous hemorrhage, glaucoma and eventual blindness. Symptoms, which include acute retinal lesions and most often the accumulation of vitreous haze that can block eyesight or the loss of visual acuity, can manifest differently from patient to patient.
Current treatments for Behcet’s disease uveitis are limited to corticosteroids and off-label use of immunosuppressive drugs, both of which can have significant side effects when used on a chronic basis.
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties. It has the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in a diverse array of disease states, including non-infectious and Behcet’s disease uveitis, cardiometabolic disease, and other auto-inflammatory diseases.
Gevokizumab is currently being studied in multiple indications. Global Phase 3 clinical programs are underway, including in Behcet’s disease uveitis, non-infectious uveitis and pyoderma gangrenosum. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
Xoma is developing gevokizumab (IL-1 beta modulating antibody) with Servier through a global Phase 3 program for Behcet’s disease uveitis and non-infectious uveitis.
Xoma also has an ongoing Phase 3 study of gevokizumab in pyoderma gangrenosum.
XMet platform: This Xoma’s proprietary platform consists of three classes of Selective Insulin Receptor Modulators (SIRMs) antibodies. The lead antibody in the XMetD program, XOMA 358, is an allosteric modulating monoclonal antibody that reduces both the binding of insulin to its receptor and down-regulates insulin signaling and could have a major effect on the treatment of abnormal metabolic states. XOMA 358 recently completed Phase 1 testing.
Servier is an independent French pharmaceutical research company with a strong international presence in 146 countries that employs more than 21,400 people worldwide. Its therapeutic pipeline comprises cardiovascular, metabolic, neurologic, psychiatric, bone and joint diseases, as well as cancer. In 2014, the company recorded revenue of 4 billion euros, 92 percent of which was generated from sales outside of France, and reinvested 28 percent of the revenue in Research and Development activities. Visit: www.servier.com.
The results of the from Phase 3 EYEGUARD-B Proof of concept and feasibility of Xoma’s product gevokizumab have, indeed, offered proof of concept, feasibility, efficacy and of principle in treating Behcet’s uveitis, and most probably, many other inflammatory diseases.
We wish the best for Xoma, whose science has been great all-along, but past managements couldn’t capitalize on its greatness. In case the time has arrived for this firm to move forward riding the favorite horse of science it still enjoys, the future could be bright. We hope this will be the case.
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