By Mary Welch
Connetics Corp. started a Phase III trial of clobetasol propionate, a foam formulation for the treatment of severe dermatoses of the scalp, including psoriasis.
The drug, called Clobetasol ViaFoam, will be given to 190 scalp psoriasis patients to compare the effectiveness of foam — similar to a mousse — with an approved clobetasol solution and a placebo.
The endpoints of the two-week study are changes in the clinical signs of psoriasis — plaque thickness, scaling and erythema, or redness. Decreases in itching and patients' opinions of the treatment also will be evaluated.
Severe scalp psoriasis is a chronic, recurrent dermatologic disease affecting some 3 million sufferers in the U.S. More than 1 million are receiving treatment at any given time. Typically, the disease involves periods of remission followed by acute reccurrence. Current treatment consists of corticosteriods in cream or liquid formulations.
"Clobetasol ViaFoam, is our second product for psoriasis and other dermatoses. It is part of our strategy to develop a family of ViaFoam products," said John Higgins, vice president of finance and administration and chief financial officer of the Palo Alto, Calif.-based company.
"Our first ViaFoam product, Luxiq, is a mid-potency steroid and is designed for moderate cases of psoriasis. Clobetasol ViaFoam is a super- high-potency steroid and is for severe cases. Both are steroids — but in two distinct classes — and call for a doctor's decision as to which product is more suitable."
When applied, both products liquefy and remain localized at the disease site. ViaFoam is designed to be easier to apply and less messy than current products, which are found in lotions, creams, ointments and gels.
Connetics expects Clobetasol's path to market will closely follow that of its sibling, Luxiq. Both were licensed from Sotec Research Pty Ltd., of Melbourne, Australia, and then formulated by Connectics.
Marketing Application Expected In Early 1999
"With Luxiq, we obtained the license, did the formulation and some preclinical work, conducted a Phase III trial, and submitted our application with the FDA within 18 months," said Higgins. "We expect to match that with Clobetasol."
The company plans to file for Clobetasol approval in early 1999, with marketing beginning in 2000. Connectics submitted its NDA for Luxiq in December 1997.
"We understand that we are moving through the FDA process (with Luxiq) and hopefully should hear by the end of the year. The FDA tries to respond within 12 months of submission, which would be December at the latest," Higgins said.
The company estimates the market for mid-potency topical steroids could hit $200 million, and $300 million for high-potency steroids.
Connetics, which changed its name from Connective Therapeutics Inc. in 1997, is a market-driven company rather than a "technology focused one," said Higgins. "Our strategy is to rapidly commercialize novel therapeutics. We get drugs in late-stage development and, by licensing them, can rapidly bring them to market and still own the commercialization rights in the U.S."
The company concentrates on two therapeutic areas: dermatology and rheumatoid arthritis.
"Both markets have large patient populations with unmet medical needs and small physician groups treating them," Higgins said. "That allows us to have a relatively manageable sale force. Fifty salespersons could effectively serve with both markets. This business strategy can yield significant opportunities."
In April, Connetics inked a $14 million deal with Suntory Ltd., of Osaka, Japan, to develop and sell ConXn (recombinant human relaxin-H2) for scleroderma in Japan. A 15- to 20-center Phase III trial should start within weeks. Connetics licensed the relaxin product from Genentech Inc. of South San Francisco. (See BioWorld Today April 27, 1998. p. 1.)
Scleroderma is characterized by thickening of the skin, caused by swelling of fibrous tissue, with the threat of eventual spread to internal organs. Patients number only 5,000 to 10,000 in Japan, and 300,000 in the U.S. About 80 percent of the victims are women.
In the more severe cases, the heart, lungs and liver become sclerotic. Between 50 and 70 percent of those patients die within five years.
Connetics also licensed from Genentech a gamma interferon product for atopic dermatitis, but it failed to achieve its primary endpoints in Phase III trials last year. (See BioWorld Today Aug. 28, 1997, p. 1.)
Connetics' stock (NASDAQ:CNCT) closed Wednesday at $3.875, down $0.125. *