West Coast Editor
Encouraged by anecdotal reports that its approved tablet treatment for periodontal disease can work against rosacea, CollaGenex Pharmaceuticals Inc. said 210 patients with the inflammatory skin condition will be enrolled in a Phase III study with Periostat (doxycycline hyclate).
"After we launched the drug [about three and a half years ago], we began to hear these reports back from dentists that patients had remarkable improvements in their complexion," said Nancy Broadbent, vice president and chief financial officer of Newton, Pa.-based CollaGenex.
"Quite frankly, we didn't believe there was an association, but now we're really excited about it," she added.
Patients in the Phase III study will get four months of dosing with either Periostat or placebo. Primary endpoints include the number of facial lesions at the end of the study compared with baseline, and an assessment by the investigator of the patient's facial redness. The trial will be finished and the data analyzed by mid-2003, Broadbent estimated.
Rosacea afflicts more than 12 million people in the U.S., and there is no cure, although topical and systemic antibiotics - with their unpleasant side effects - often are used. Tetracycline, for example, is often used off-label for the condition, but brings with it gastrointestinal upset and photosensitivity.
Metronidazole also is used topically as a cream or gel, but "doctors don't see it as a cure-all, and they're crying out for a systemic medication that patients can take every day and maintain the clearness of their faces," Broadbent said.
The main symptom of rosacea is erythema, or skin redness, which can be worsened by spicy foods and alcohol and which often spreads across the nose, cheeks and forehead. Patients can develop spider veins, called telangiectasia, near the surface of the skin of the cheeks and nose, and may develop lesions as the disease advances.
CollaGenex believes Periostat may have benefit against moderate acne vulgaris, which has symptoms similar to rosacea. Last year, the company ran a 40-patient trial in college students who showed a more than 50 percent reduction in acne lesions and blackheads.
"We called it a Phase II trial but we really did it as a pilot study," Broadbent said, and the company set up an advisory board afterward.
"Our CEO likes to tell the story that he had put the kibosh on them doing the acne trial because he was so convinced it wouldn't work, and they went ahead and did it anyway," she told BioWorld Today.
CollaGenex is going ahead with a Phase III trial in rosacea because the disease is similar to acne, but the need for a new drug is greater in rosacea.
"We've been conducting market research groups with dermatologists," Broadbent said. "A number of them have been prescribing [Periostat for rosacea] themselves, on their own. We're getting a lot of buzz out there."
If results are promising from the Phase III trial in rosacea, would the company go into Phase III trials in acne?
"It's too early to say, but the view currently is that we wouldn't need to," Broadbent said. "Many dermatologists may make the connection, and we can only fund so many trials."
Periostat also may be applicable to such disorders as meibomianitis (inflammation of the sebaceous glands of the eyelids) and cancer metastasis, and the company is exploring the possibility of treating those indications with Periostat, while looking into a series of other compounds known as IMPACS, or Inhibitors of Multiple Proteases and Cytokines.
The company's stock (NASDAQ:CGPI) closed Tuesday at $5.90, up 27 cents.