Pharmos Corp. (PARS.PK) provided an update on the ongoing clinical trial using its compound levotofisopam (S-tofisopam) to treat patients with hyperuricemia and gout.
This phase 2a proof-of-concept trial is being conducted at the Duke Clinical Research Unit of Duke University and the principal investigator is John Sundy, MD, PhD an expert in the treatment of gout. The trial is designed to assess the safety and efficacy of levotofisopam as a uric acid lowering agent in patients with gout, the company said.
On January 10, 2012 the Company announced that the first patients in this clinical trial had been dosed. The trial expects to enroll 20 patients in an open label study with patients confined in the Duke facility. The study enrolls patients with serum urate between 8 and 12 mg/dL. Subjects receive a single dose of 50 mg on days 1 and 7 and 50 mg TID on days 2 through 6.
As of April 5, 2012, 13 patients have completed treatment and all patients showed a significant reduction in serum urate concentration. The mean reduction was over 45%. Additionally there was an increase in the fractional excretion of urate confirming the compound's mechanism of action as enhancing urate excretion.
The Phase 2a trial is expected to be completed in May 2012 and the Company's strategy is to seek a partner for the further development of levotofisopam.
Levotofisopam is the S-enantiomer of the racemic mixture RS-tofisopam, a well tolerated agent used for the treatment of a variety of disorders associated with stress or autonomic instability. Dextofisopam, the R-enantiomer, is being developed for the treatment of irritable bowel syndrome (IBS) and has completed testing through phase 2b in the US.
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