UCB/Immunomedics's lupus drug positive in Phase IIb trial
This article was originally published in Scrip
UCB and Immunomedics's epratuzumab outperformed placebo in a Phase IIb trial of systemic lupus erythematosus (SLE) patients, show top-line results. In keeping with previous expectations, the companies plan to proceed into Phase III development in the second half of 2010.
Epratuzumab is a humanised anti-CD22 monoclonal antibody that lowers lymphocytic B cell activity and thereby inhibits the production of self-targeting antibodies. Developed by Immunomedics, for which it is the lead candidate, it is licensed to UCB for autoimmune disease uses. Immunomedics has maintained rights to the drug for oncology indications.
The Phase IIb lupus trial involved 227 patients with moderately to severely active disease in multiple organ systems, and lasted 12 weeks. Patients were randomised into six treatment arms – five different doses and regimens of the drug versus a placebo arm. The primary efficacy measure combined several indices of SLE disease activity, but emphasised improvement on the British Isles Lupus Assessment Group (BILAG) scale.
The treatment advantage of epratuzumab over placebo was 24.9% at week 12. The trial, which was aimed at identifying a dose and regimen to proceed with, was not powered to assess whether this was a statistically significant difference, said a company spokesman.
The drug is also being evaluated in an ongoing open-label Phase II trial, with 175 patients, which is not due for completion until 2014.
In a previous open-label Phase II study in 14 patients with moderately to severely active SLE, epratuzumab lowered global BILAG scores by 50% in nine patients. The drug was also previously in two Phase III trials for SLE, but these trials were terminated early because of manufacturing problems leading to drug shortages. Partial data from the trials showed that the drug reduced disease activity and patient reliance on corticosteroids (scripnews.com, November 14th, 2008).
It has been decades since a new SLE drug has made it to market, and recent research efforts have offered both promise and disappointment.
GSK/Human Genome Sciences' LymphoStat-B (belimumab), a B-cell activating factor, had favourable results in a Phase III trial in July, prompting a 277% increase in Human Genome Sciences share price on Nasdaq (scripnews.com, July 21st, 2009). By contrast, Genentech/Biogen terminated development of the blockbuster, CD20-antibody, Rituxan (rituximab) for SLE earlier this year when the drug failed in Phase III trials (scripnews.com, March 13th, 2009).
Pfizer's best-selling cholesterol drug Lipitor (atorvastatin) is in Phase II/III trials in the condition, and ImmuPharma's T-cell inhibitor Lupuzor (IPP-201101) is being prepared for Phase III trials.