Despite promising looking Phase 1 and initial Phase 2 dose finding studies, Incyclinide will no longer be developed as a treatment for rosacea. Incyclinide is a chemically modified tetracycline that its developers – Collagenex, was hoping would become another systemic treatment for rosacea. We did get a warning in May that clinical trials for Incyclinide weren’t all going smoothly – when the dose finding trials for acne found that 40mg a day causes photo-toxicity.
From the press release: CollaGenex Pharmaceuticals Announces Results of Phase 2 Dose-Finding Study of Incyclinide for the Treatment of Rosacea
The study demonstrated that incyclinide was well-tolerated, with most adverse events being mild or moderate. However, the patients who were administered incyclinide did not demonstrate a greater reduction in inflammatory lesions than the patients on placebo at any time point during the study.
…
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, “We are surprised and disappointed that the results of this large, well-controlled Phase 2 study did not support the findings of an earlier, much smaller pilot study in rosacea patients. On the basis of these results, we will not be pursuing further clinical development of incyclinide in rosacea patients.
This is disappointing for rosacea sufferers, and again proves the high risk of developing new treatments for rosacea. Collagenex will continue to develop Incyclinide as an acne treatment (and indeed as a treatment for diseases other than rosacea) and also continue to develop COL-118/Sansrosa for facial redness. Collagenex is of course also responsible for the low dose doxycycline treatment it called Oracea.
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Well now the entire incyclinide program has been canned for now. But since Oracea is a similar antibiotic product that works, I don’t think it’s a huge loss.
Very true Ben, I’m sure Collagenex, and indeed Galderma are too busy counting the cash from Oracea sales to worry about what might have been with Incyclinide.