By Frances Bishopp
With Phase II results of its product ConXn for scleroderma reported only two months ago, Connetics Corp., true to its short-time-to-market strategy, has reported positive Phase III results of betamethasone valerate for psoriasis ahead of schedule.
The Palo Alto, Calif.-based company plans to file a new drug application (NDA) with the FDA to market the product for use in all steroid-responsive dermatoses, including psoriasis, in the first quarter of 1998, Thomas Wiggans, president and CEO of Connetics, told BioWorld Today.
The placebo-controlled, randomized, double-blind trial involved 190 patients. The multicenter Phase III study demonstrated that patients treated with betamethasone mousse, administered twice a day for 28 days, experienced a statistically significant improvement over patients in the groups treated with betamethasone lotion (the same concentration of betamethasone in a lotion form) or placebo in all primary endpoints, including erythema (redness of the skin), plaque thickness and scaling.
Overall, a physicians' global assessment showed 71 percent of patients treated with the mousse formulation had complete or almost complete clearance compared with 46 percent treated with the lotion and 18 percent treated with placebo.
Both the betamethasone mouse and lotion were generally well tolerated.
Betamethasone mousse is a stabilized foam formulation of betamethasone 17-alpha-valerate. When applied to the body, betamethasone mousse liquefies and remains localized at the disease site. It is currently on the market in the U.K. for the treatment of scalp psoriasis and seborrheic dermatitis.
Connetics' short-time-to-market strategy involves licensing promising or approved products from other companies, Wiggans explained. The Phase III results of betamethasone mousse were another validation of company strategy, he said.
"Rather than a technology focus, we have a market focus," Wiggans said. "We are looking for marketed or late-stage products within that strategic focus."
Connetics currently has four products in clinical trial. The Phase II clinical trial of ConXn (recombinant human relaxin H2) for scleroderma involved 64 patients randomized into one of two treatment groups, 25 mg/kg per day or 100 mg/kg per day, and a placebo group.
In the lower dose group, statistical significance was found in skin score improvement, with a 31 percent reduction in skin scores. The higher dose, however, had no effect on the treatment group compared to placebo.
Wiggans said Connetics hopes to meet with the FDA before the end of the year and will seek an expedited review process to move ahead to a pivotal trial.
Another product for Connetics is gamma interferon for the treatment of atopic dermatitis and keloids, which was the subject of a completed Phase III clinical trial. Wiggans said results currently are being analyzed and will be reported in early October. Gamma interferon was acquired from Genentech Inc., of South San Francisco, in 1995.
Connetics also has a multiple sclerosis vaccine in a Phase I/II, 100-patient clinical trial, with results expected by the end of the year.
Connetics changed its name in May 1997 from Connective Therapeutics Inc., with the launch of the company's first product, ridaura (an oral gold product) for rheumatoid arthritis, and the establishment of its first sales force, Wiggans said. Ridaura was acquired from SmithKline Beecham, of Philadelphia, last December and has been on the market for approximately 10 years.
Connetics had approximately $20 million cash on hand as of June 30, 1997. Connetics' stock (NASDAQ:CNCT) closed Tuesday at $8.375, up $0.50. *