Pharmacological effects of CS-0777, a selective sphingosine 1-phosphate receptor-1 modulator: results from a 12-week, open-label pilot study in multiple sclerosis patients

  • J Neuroimmunol. 2012 May 15;246(1-2):100-7. doi: 10.1016/j.jneuroim.2012.03.007.
James B Moberly  1 ,  Daniel M Ford ,  Hamim Zahir ,  Shuquan Chen ,  Takashi Mochizuki ,  Kenneth E Truitt ,  Timothy L Vollmer
Affiliations
  • 1. Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, New Jersey 08837, USA. [email protected]
PMID: 22465063 DOI: 10.1016/j.jneuroim.2012.03.007
Abstract

CS-0777 is a selective sphingosine 1-phosphate receptor-1 modulator under investigation for treatment of multiple sclerosis (MS). We conducted an open-label, pilot study in 25 MS patients to assess the safety, pharmacokinetics, pharmacodynamics and exploratory efficacy of oral CS-0777 (0.1, 0.3 and 0.6 mg), administered once weekly or every Other week for 12 weeks. CS-0777 resulted in a pronounced, dose-dependent decrease in lymphocytes and CD4 T cell subsets, which returned to baseline within 4 weeks after the last dose. Overall, CS-0777 was safe and well-tolerated. These results require confirmation in a double-blind, placebo-controlled and adequately powered phase 2 study in MS.

Products