Connective Therapeutics Inc. said within the next two months itexpects to begin a Phase III trial of gamma interferon for peoplesuffering from severe atopic dermatitis, a debilitating inflammatoryskin disease characterized by redness, swelling, itching and abrasionscaused by scratching.
The Palo Alto, Calif., company Friday also reported positive long-term follow-up data from patients who participated in a 12-weekPhase II study. The analysis showed the body surface area andsymptoms associated with the disease were significantly reducedfollowing one and two years of gamma interferon therapy. Thefindings also revealed side effects were minimal.
Scott Harkonen, Connective Therapeutics' senior vice president ofproduct development and operations, said the Phase III trial, which isslated to begin in the next four to eight weeks, will have as itsprimary endpoints reduction of symptoms and reduction inmeasurement of disease activity, such as redness of skin, swelling andscratching-related abrasions.
A major secondary endpoint, he said, will be improvement in qualityof life so that patients can return to normal activities. People withatopic dermatitis experience numerous interruptions in their lives,such as an inability to work or sleep.
Current treatments for the disease include steroids, which can haveserious side effects.
Gamma interferon is a lymphokine involved in regulation of theimmune system. Connective Therapeutics licensed the drug fromGenentech Inc., of South San Francisco, for treatment ofdermatological diseases. Genentech already sells gamma interferonunder the brand name Actimmune for chronic granulomatous disease,which is an immunodeficiency disorder leaving patients susceptibleto bacterial and fungal infections.
Genentech conducted Phase I and II studies of gamma interferon foratopic dermatitis. Connective Therapeutics, in addition to the PhaseIII study, is planning a Phase II trial of the drug for keloids, whichare enlarged scars caused by excessive collagen in the skin.
Connective Therapeutics' placebo-controlled Phase III trial for atopicdermatitis will involve 450 patients with moderate to severe diseaseand take 12 weeks to complete.
Patients will be divided equally into a placebo and two treatmentgroups. Those receiving the drug will get injections either daily orevery other day. All patients will receive the same dose _ 50micrograms per meter squared of body surface. Those taking the drugevery other day will receive a placebo on the off day.
In the long-term evaluation of participants in the 12-week Phase IIstudy, patients continued to receive gamma interferon for one andtwo years. Those who took the drug for a year entered the trial withdermatitis over an average 56 percent of their bodies and experiencedan average 35 percent reduction in disease area. Patients whoreceived the treatment for two years went from an average 60 percentbody surface covered by the dermatitis down to 36 percent.
Connective Therapeutics' stock (NASDAQ:CNCT) closed Friday at$11, up 50 cents. n
-- Charles Craig
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