By Karen Pihl-Carey
Staff Writer
In response to positive Phase II data, Biogen Inc. began a pivotal trial with Amevive in patients with chronic plaque psoriasis.
Investigators presented the Phase II data Friday at the Psoriasis: Gene to Clinic meeting in London. The Phase III trial, just initiated in the U.S., is intended to support registration.
Assuming that all goes well, I would say we could anticipate a commercial launch in 2002, said Kathryn Bloom, director of communications at Biogen, of Cambridge, Mass. But obviously, the drug has to be proven to be safe and effective.
The Phase II trial was a placebo-controlled, randomized, double-blind study in patients with moderate to severe chronic plaque psoriasis.
A total of 229 patients at 22 sites in the U.S. were treated with placebo or Amevive, at does of .025 mg/kg, .075 mg/kg, or .15 mg/kg, by intravenous bolus injection once a week for 12 weeks. They were observed an additional 12 weeks.
Data showed Amevive (recombinantly engineered LFA-3/IgG1 human fusion protein) was well tolerated with a favorable safety profile. It also provided a significant therapeutic effect, clearing psoriasis rapidly, and caused no increase in infection or evidence of cytokine-release or capillary-leak syndromes, the investigators said.
In fact, the two highest doses of Amevive produced statistically significant clearance or almost complete clearance of psoriasis. And patients treated with Amevive reported significantly more improvements in skin-related symptoms, role and social function and emotional well-being, compared with patients receiving placebo.
Researchers measured disease severity by physician assessments and the Psoriasis Activity and Severity Index. The quality of life data was measured by the Dermatology Life Quality Index and the Dermatology Quality of Life Scales.
Bloom said Amevive would offer psoriasis patients a better alternative to their current therapies. The existing therapies are not optimal, she told BioWorld Today. There are problems with long-lasting toxicities. We feel that Amevive may offer a novel approach in treating psoriasis.
Also in the Phase II study, Amevive reduced memory-effector T cells, which play a role in the pathogenesis of psoriasis. The drug, however, did not reduce naove T cells, indicating it did not suppress immune function broadly.
Psoriasis is an inflammatory disorder characterized by red, scaly, thick plaques that cause discomfort. About 1 percent to 2 percent of people in North America and Europe have the disorder, and about 1 million people have the moderate to severe form.
Aside from Amevive, Biogen has Adentri (adenosine A1 antagonist) in Phase II trials for edema associated with congestive heart failure and in an open-label study for renal transplantation.
Biogen also has Avonex in Phase III trials for people who are at a high risk formultiple sclerosis (MS) and in people with secondary progressive MS. Avonex has been on the market since May 1996 for relapsing forms of MS. Analysts expect the blockbuster MS drug will reach $1 billion in sales by 2002.
In October, Biogen halted six Phase II trials of Antova, a humanized anti-CD40 ligand antibody, because several patients developed blood clots. Antova was being tested in Factor VIII inhibitor syndrome, islet cell transplantation, MS, immune thrombocytopenic purpura, kidney transplantation and systemic lupus erythematosus. (See BioWorld Today, Oct. 25, 1999, p. 1.)
Bloom said the company is still reviewing what to do with Antova.
The companys stock (NASDAQ:BGEN) closed Friday at $76.50, down 50 cents.