By Brady Huggett
Biogen Inc. and partner Elan Corp. reached their previously announced goal of beginning Phase III trials of Antegren (natalizumab) in both multiple sclerosis and Crohn¿s disease this year.
¿We are on track and things are going well,¿ said Kathryn Bloom, senior director, public affairs at Biogen, adding that the Elan-Biogen partnership is functioning smoothly.
Biogen, of Cambridge, Mass., and Elan, of Dublin, Ireland, have a mound of clinical work ahead of them. They will conduct two Antegren Phase III trials in multiple sclerosis (MS) ¿ the AFFIRM trial (Antegren safety and efficacy in relapsing-remitting MS) and the SENTINEL trial (safety and efficacy of natalizumab in combination with Avonex in subjects with relapsing-remitting MS).
The AFFIRM trial is a two-year, double-blind, randomized, placebo-controlled, multicenter study involving about 900 patients. It is designed to determine if Antegren is effective in slowing the rate of disability in MS and reducing the rate of clinical relapses. The SENTINEL trial is similar in design except that it will involve 1,200 patients and will seek to determine whether Antegren in combination with Avonex is more effective than Avonex alone in slowing the rate of disability in MS and in reducing the rate of clinical relapses.
The second batch of Phase III studies, the Crohn¿s disease trials, is nearly as hefty.
The first is a randomized, multicenter, placebo-controlled, double-blind study of about 850 patients ¿ making it the largest ever to be conducted in Crohn¿s disease, Biogen said ¿ and is designed to measure both the response and ability to induce remission in patients at week 10 of administration of Antegren. The second trial will evaluate 300 patients and is designed to evaluate the effect of Antegren on the duration of response and remission in patients with Crohn¿s disease. Patients in these trials will be treated for 15 months, Bloom said.
Biogen entered its collaboration with Elan in August 2000, gaining exclusive worldwide development, manufacturing and commercialization rights to Antegren. Financial details of the agreement were not disclosed. Antegren was in Phase II trials at the time. Since then, the companies released positive Phase II data in January and set their sights on Phase III work. (See BioWorld Today, Jan. 24, 2001.)
Besides the MS and Crohn¿s disease indications, Bloom said Biogen is investigating Antegren¿s use in other autoimmune afflictions. But, as 2002 approaches, Biogen also has other products on its mind.
¿In 2002, we have Amevive, our psoriasis drug, up for approval with regulatory authorities ¿ that review will be taking place,¿ Bloom said. ¿We have a very aggressive and attractive pipeline, both near term and long term, as well.¿
Biogen filed its applications for Amevive, designed to selectively target the CD45RO+ subset of T cells, simultaneously in the United States and Europe using a common technical document. (See BioWorld Today, Oct. 7, 2001.)