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news.CollaGenex Pharmaceuticals has suspended enrollment in a phase II dose-finding study incyclinide for the treatment of acne after one patient experienced significant phototoxicity.
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Phototoxicity involves an extreme reaction to sunlight, which can cause burning and blistering to the skin. It is a known side effect of tetracyclines, the drug class that incyclinide belongs to.
CollaGenex is currently investigating this adverse event and plans to meet with the FDA to discuss the ongoing development program for the drug candidate.
Colin Stewart, president and CEO of CollaGenex, said: “Our principal concern is the safety of our patients, and we are suspending further enrollment in the 40mg cohort of this trial while we investigate this adverse event.
“Since we observed no adverse events at lower doses, we are continuing the phase II dose-finding trial of incyclinide for the treatment of rosacea.”