UCB Commences Patient Enrolment - Analyst Blog

UCB (UCBJF) along with partner Immunomedics Inc. (IMMU) recently started patient enrollment in a late-stage trial of epratuzumab in patients with moderate-to-severe systemic lupus erythematosus (SLE). The trial (EMBODY 1) is one of two pivotal phase III trials. The second study, EMBODY 2, has also begun patient enrollment.

Both EMBODY 1 and EMBODY 2 are being conducted to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab when given with standard-of-care treatments in patients with moderate-to-severe SLE. Each study will last a maximum of 54 weeks and will involve 780 patients.

UCB licensed epratuzumab from Immunomedics. Earlier, in November, the companies reported positive data on epratuzumab from a phase IIb trial (EMBLEM). The trial demonstrated that cumulative dosing of the candidate for all dosage strengths (200 mg to 3,600 mg) during the 12-week cycle resulted in superior response rates compared to placebo.

The EMBLEM trial also established that patients treated with epratuzumab showed signs of improvement as early as the eighth week with progress in health noted at the end of week 12.

Systemic lupus erythematosus is an autoimmune disease, which can result in inflammation and tissue damage.

We currently have a Zacks #2 Rank (short-term Buy rating) on UCB. We view the initiation of patient enrollment in the late-stage trial of epratuzumab as a positive for the company, given the dearth of effective treatment options available to patients suffering from SLE. However, we note that GlaxoSmithKline plc (GSK) and Human Genome Sciences Inc. (HGSI) could gain approval for their SLE candidate, Benlysta, in the first quarter of 2011.