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news.Critical Theraputics' asthma drug Zyflo has failed to significantly reduce the number of inflammatory lesions in patients with acne in a phase II study. However, the drug was found to be safe and well-tolerated and a trend towards significance was observed in certain endpoints.
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The study showed a mean percent decrease in inflammatory lesions of 33.5% in patients treated with Zyflo, compared to 26.9% in the placebo group. Critical Therapeutics said that it is continuing to analyze the data to determine the appropriate next steps for the development of the drug in the treatment of patients with acne.
The phase II study involved 101 patients with moderate to severe inflammatory facial acne who received a four-times-daily 600mg dosage of Zyflo, or placebo, for 12 weeks. Patients were enrolled into the study at 12 sites across the US and ranged in age from 12 to 44 years.
“We believe this small trial supports that 5-LO inhibition may be a useful therapy in patients with moderate to severe inflammatory acne,” said Critical Therapeutics president and CEO Dr Paul Rubin, “The relative severity of disease and size of the patient population in this study have given us valuable information to consider for the design of any clinical trials in acne patients that we may decide to pursue in the future.”
Zyflo blocks the activity of 5 lipoxygenase (5-LO), which is believed to play a central role in tissue inflammation related to asthma, acne and other diseases.