Connetics Corp.'s second foam formulation for the treatment of scalp psoriasis cleared a Phase III trial as Olux (clobetasol propinate, 0.05 percent) showed statistically significant improvement over a placebo. The 188-patient, randomized, double-blind, multicenter study showed that patients given Olux twice a day for 14 days improved over the placebo group in the endpoints of erythema, plaque thickness and scaling.
In addition, a physicians' global assessment showed that, overall, 74 percent of the patients treated with Olux had complete or almost complete clearance of disease compared with 63 percent for a currently approved clobetasol solution and 8 percent for the placebo. A new drug application (NDA) should be filed by mid-1999, the company said.
"Skin diseases are typically treated with topical agents, such as lotions, gels or ointments, which can be greasy," said John Higgins, chief financial officer for the Palo Alto, Calif.-based company. "The delivery vehicle is really important, not only for patient preference but for the effectiveness of the drug."
Connetics' initial target indication is severe psoriasis and other dermatoses of the scalp. Scalp psoriasis is a chronic, recurrent dermatologic disease that affects some 3 million people in the U.S., with more than 1.2 million patients in treatment at any time. Current treatment consists of corticosteriods in cream or liquid formulations.
Patients with severe scalp psoriasis suffer from various degrees of erythema, scaling, plaque and itching associated with the disease. The disease course typically involves periods of remission followed by acute exacerbation.
"We believe the market for high and super-high potency steroids — and Olux is a super-high potency steroid — is about $300 million in the United States," Higgins said. "We believe we could capture 5 to 10 percent of that market."
Connetics licensed the FDA-approved clobetasol from Soltec Research Pty Ltd., of Melbourne, Australia, and then formulated it into a foam-mousse delivery version. Now dubbed Olux, this super high-potency corticosteriod, liquefies when applied to the scalp and is designed to achieve rapid and targeted delivery of the active drug to the disease site.
Connetics' first drug for scalp psoriasis, Luxiq (betamethasone valerate foam 0.1 percent), is a mid-potency steroid designed for moderate cases of psoriasis — a market of about $200 million. The company submitted the NDA for Luxiq in December 1997.
Connetics' stock (NASDAQ:CNCT), closed Wednesday at $4.187, up $0.563. n