Abbott starts head-to-head MS trial
pharmafile | May 25, 2010 | News story | Research and Development, Sales and Marketing |Â Â Abbott, Avonex, Biogen, Gilena, daclizumabÂ
Abbott has started enrolment for a phase III trial of daclizumab, a once-monthly injection for relapsing-remitting multiple sclerosis that it is developing with Biogen Idec.
A humanised monoclonal antibody, daclizumab was part of a collaboration between Biogen and Facet Biotech, which Abbott acquired in April.
The new trial puts daclizumab head-to-head with Avonex (interferon beta 1-a), the blockbuster standard therapy for relapsing-remitting multiple sclerosis (RRMS) developed by Biogen.
The global phase III is know as DECIDE and is expected to enroll approximately 1,500 RRMS patients across 28 countries.
Abbott’s VP of global pharmaceutical clinical development Eugene Sun said: “Initiating the phase III DECIDE trial is a tremendous milestone for the collaboration as it brings daclizumab one step closer to becoming a potential new treatment option for patients with MS.
“Extensive preclinical and clinical experience with daclizumab suggest this drug holds promise as a new approach for the treatment of MS, and we look forward to expanding our knowledge further with the DECIDE trial.”
Daclizumab is also being investigated in the ongoing phase IIb registration-enabling SELECT trial, which is evaluating the efficacy and safety of monthly subcutaneous doses of either 150mg or 300mg of daclizumab monotherapy.
There are currently two new oral RRMS treatments filed for regulatory review that daclizumab may compete with if it comes to market.
The first is from Merck Serono, which also markets its own injectable form of interferon beta1-a Rebif, and has filed its oral MS treatment cladribine with the FDA.
The second is Novartis’ Gilenia (FTY720), a once-daily oral treatment that was found to reduce relapse rates significantly in its recent phase III FREEDOMS trial.
Novartis’ Gilenia sees regulatory review extension
But Gilenia has just suffered a setback in the race to bring the first oral RRMS treatment to market after the FDA extended its priority review by three months.
Novartis expected this decision when the priority review was announced in February and remains in a strong position to get to market before Merck Serono’s cladribine – which suffered a regulatory setback of its own in November last year after receiving a ‘refuse to file’ letter.
The FDA originally granted Gilenia priority review status in February 2010, reducing the standard 10-month review period to six months, and this was set to end on 21 June. The regulator grants priority reviews for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists.
The end date for Gilenia’s review has now been extended to September after the FDA requested a further analysis of the available data.
Ben Adams
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