incyclinide dosage trials: 40mg too much

Collagenex has announced that their ongoing trials to find the best dosage for Incyclinide have discovered that 40mg can cause photo-toxicity.

Collagenex is conducting parallel Phase II trials for Incyclinide for both acne and rosacea.

As detailed in a recent news item, incyclinide targets conditions other than rosacea, Incyclinide differs from a non-antibiotic tetracycline in that it is also chemically modified. Thus we might expect that Incyclinide will offer different benefits compared to oracea.

It will be interesting to see how Collagenex decides to market Incyclinide, especially given that it has invested heavily in the development of another tetracycline based systemic treatment targetted at rosacea – namely Oracea.

From: CollaGenex Pharmaceuticals Discontinues 40 mg Cohort of Phase II Dose-Finding Study of Incyclinide for the Treatment of Acne

Klaus Theobald, M.D., Ph.D., said, “One of the objectives of our Phase II dose-finding study of incyclinide for the treatment of acne was to determine a maximum effective or maximum tolerated dose. We have already identified a minimum effective dose at 10 mg and greater efficacy at 20 mg, with side effects similar to placebo at these doses. Because we have determined there to be unacceptable drug-related adverse events in the 40 mg cohort, we are discontinuing this cohort. Since we observed no adverse events at lower doses, we are evaluating our options for the continuing development of incyclinide in acne at lower doses, and we are continuing the Phase II dose-finding trial of incyclinide for the treatment of rosacea.”

Research has shown that compounds can be created by chemically modifying certain tetracyclines and that these new compounds have properties that may make them effective in treating diseases involving inflammation and/or destruction of the body’s connective tissues. CollaGenex is evaluating various chemically modified tetracyclines (so called “IMPACS”(TM) compounds because they are Inhibitors of Multiple Proteases And CytokineS) to assess whether they are safe and effective in these applications.

Further Reading ;

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