Celgene (CELG) Reports Data On Lupus Drug In Phase II Trial

 | Jun 15, 2017 05:45AM ET

Celgene Corporation (NASDAQ:CELG) announced results from the phase II trial, SLE-001 at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid. The trial evaluated investigational candidate, CC-220,

The data showed greater improvement with CC-220 (an oral immunomodulatory compound) treatment compared with placebo in multiple measures of disease activity, as measured by standard scores employed in clinical trials in patients with systemic lupus erythematosus (SLE), commonly known as lupus.

The trial randomized 42 patients who were diagnosed with lupus at least six months before and had a baseline SELENA-SLEDAI score greater than or equal to four. The patients were randomized to one of four escalating doses of CC-220 (CC-220 0.3 mg every other day, 0.3 mg once daily, 0.3 mg alternating with 0.6 mg once daily and 0.6 mg once daily) or placebo for 12 weeks. This was followed by 12 weeks of observational follow-up or long-term extension. The study evaluated safety, tolerability and pharmacokinetics.

The data was presented by Celgene International Sàrl, a wholly owned subsidiary of Celgene.

However, serious adverse events (AEs) were reported in two patients in the two highest CC-220 doses combined (pneumonia in both cases) and in two patients in the placebo group. Five patients in the two highest CC-220 dose groups and one patient in the placebo group discontinued due to AEs.

CC-220 is also being evaluated for multiple myeloma.