CT's acne drug Zyflo fails in Ph II trial

Critical Therapeutics of the USA says that data from a recent Phase II trial of its Zyflo Filmtab (zileuton) in patients with moderate-to-severe inflammatory facial acne did not show statistical significance in its primary efficacy endpoint. The group's shares closed down 2.8% at $6.90 following the news on July 14.

Results showed that patients receiving zileuton, which works via inhibition of the enzyme 5 lipoxygenase (5-LO), exhibited positive responses to therapy and a trend toward significance in certain endpoints, but these did not reach statistical significance when compared to the control arm.

Patients treated with the agent experienced a mean reduction in inflammatory lesions of 33.5% versus 26.9% in the placebo group (p=0.384). Those administered zileuton showed a mean reduction in the total number of lesions of 25.3 compared to 16.4 lesions in the control arm (p=0.085). It was also found that the drug was well-tolerated with no serious adverse events recorded.