Phase III Data On A Low-Residue Clobetasol Propionate Foam Used In The Treatment Of Scalp Psoriasis Is Presented At The American Academy Of Dermatology 58th Annual Meeting

Market Wire, 20050229

Phase III clinical trial data, on OLUX™ (clobetasol propionate) Foam, 0.05%, an investigational low-residue foam formulation used to treat scalp psoriasis, were presented today at the annual meeting of the American Academy of Dermatology. Scalp psoriasis, a difficult-to-treat condition affecting more than 3.2 million Americans, is marked by redness and scaling of the scalp, severe itching and irritation. A new drug application for OLUX for the treatment of corticosteroid-responsive scalp dermatoses is pending review by the Food and Drug Administration.

At the end of the 14-day study of twice daily treatments, 74 percent of the patients treated with OLUX (clobetasol propionate) Foam, 0.05%, were clear or almost clear of their scalp psoriasis, versus 63 percent of those treated with the clobetasol propionate (CLO) solution, 0.05%. Additionally, only 10 percent and 6 percent of those treated with placebo foam and placebo solution, respectively, showed similar improvement.

Efficacy was evaluated by grading the signs and symptoms of scalp psoriasis, including plaque thickness, scaling, erythema and pruritus, and by assessing the overall response to treatment at the end of the study. The difference between OLUX and CLO solution for scaling was statistically significant, favoring OLUX.

In the study, OLUX and CLO solution treatments were equally well tolerated. This new data indicates that OLUX was successful in treating moderate-to-severe scalp psoriasis, was well tolerated and moves Connetics closer to providing low-residue treatments for all degrees of the condition, said Ken Washenik, M.D., Ph.D. a clinical investigator in the trial. Dr. Washenik is Director of Dermatopharmacology at New York University Medical Center. "If approved, OLUX has the potential to complement Luxíq in a continuum of care for scalp psoriasis.

Luxíq™ (betamethasone valerate) Foam, 0.12%, another topical drug from Connetics using the foam delivery system, was approved for marketing by the Food and Drug Administration (FDA) in March 1999, for the treatment of corticosteroid-responsive dermatoses of the scalp. Luxíq is a mid-potency steroid.

Connetics Corporation, headquartered in Palo Alto, California, is focused on the acquisition, development and commercialization of marketed and late-stage products. Connetics currently markets Ridaura® (auranofin), a treatment for rheumatoid arthritis, and Luxíq for the treatment of corticosteroid-responsive dermatoses of the scalp. Besides OLUX, another investigational product under development is ConXn® (recombinant human relaxin) for the treatment of scleroderma, infertility, peripheral vascular disease and other fibrotic diseases. For more information on Connetics, you may visit the Connetics Web Site at http://www.connetics.com.