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Pharmos initiates gout drug proof-of-concept trial

Pharmos has initiated the Phase 2a proof-of-concept trial of its compound levotofisopam (S-tofisopam) as a uric acid lowering agent in patients with hyperuricemia and gout at the Duke Clinical Research Unit of Duke University in the US.

Levotofisopam, the S-entantiomer of the racemic mixture RS-tofisopam, is said to be a well tolerated, effective, nonsedating agent used to treat various disorders related to stress or autonomic instability.

The trial follows two Phase 1 clinical studies that were completed by Vela Pharmaceuticals in collaboration with Pharmos in October 2006.

The previous studies showed that levotofisopam treatment was generally well tolerated and was associated with a large and rapid reduction in serum uric acid values.

Pharmos, which owns the rights to both R- and S-tofisopam, the two enantiomers of racemic tofisopam, through two US issued composition-of-matter patents, plans to seek a partner to further develop levotofisopam for the treatment of gout after completion of this proof-of-concept clinical trial.