Sansrosa Phase 3 Delayed until END of 2008

Written by on March 13, 2008 in Sansrosa with 3 Comments

According to the just published earnings call, Collagenex have been asked to undertake a additional Phase 2 study before commencing Phase 3. These additional studies will take several months, delaying the start of Phase 3. Collagenex are still hopeful of commencing Phase 3 studies some time before the end of 2008.

These additional studies are to confirm that the diseased rosacea skin does not allow more of the active ingredient to absorbed into the blood, compared to healthy volunteers. The Phase 1 trials showed that healthy volunteers did not have measurable quantities in their blood plasma.

From CollaGenex Pharmaceuticals Q4 2007 Earnings Call Transcript

Prior to starting the Phase III studies, the FDA has requested that we do a small additional Phase II study, which we anticipate will enroll about 20 patients and take several months to complete. The purpose of this study is to augment data from a Phase I bioavailability study that we conducted — that showed that administration of COL-118 to the skin of healthy volunteers did not yield measurable levels of 118 in plasma.

As a safety precaution, FDA has requested that we repeat this study in rosacea patients to demonstrate that plasma levels of COL-118 are not increased in patients with the disease skin of rosacea. We anticipate completing the study in the third quarter of 2008 and commencing our Phase III clinical trials before the end of 2008.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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3 Reader Comments

  1. Ben says:

    Very frustrating…

    There was some good news however… They agreed on phase 3 criteria guidelines, which was the first step to get the ball rolling on phase 3.

  2. Yeah I guess the news could be worse – if healthy skin was allowing the active ingredient to get into the blood then there would probably be no more product !

  3. Ben says:

    Yeah. the patent shows a concentration similar to Alphagan P, which is safe for use on the eye. The eye is known to absorb more to the body than the skin anyway… so is should be very very safe. But I guess we’ll stayed tuned…

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