Daclizumab HYP tops Avonex in multiple sclerosis trial

Biogen Idec and AbbVie’s multiple sclerosis candidate daclizumab HYP has moved a little closer to approval after outperforming interferon beta therapy in a Phase III trial.

The subcutaneously-administered, once-monthly drug achieved a significant reduction in disease activity in patients with the relapsing-remitting form of MS compared with Biogen Idec’s $3bn-a-year Avonex (interferon beta-1a) therapy, cutting the number of relapses by 45% over the course of a year.

Daclizumab HYP (high yield process) – which will be marketed as Zinbryta if approved – also reduced the number of new MS lesions by 54% compared to the older drug and seemed to slow down disability progression by around 16%, although the latter finding was not statistically significant.

The results of the DECIDE study “help us better understand Zinbryta as a potential treatment option for people with relapsing-remitting MS,” commented lead investigator Ludwig Kappos of University Hospital in Basel, Switzerland.

The active ingredient in the drug was previously on the market in Roche’s organ transplant rejection therapy Zenapax, which was withdrawn from sale in 2008 after competing products entered the market, although Biogen Idec and AbbVie have tweaked the formulation.

AbbVie acquired rights to daclizumab when it bought Facet Biotech in 2010 and the two partners now say they intend to move ahead with .

Just where daclizumab HYP might fit into the increasingly crowded MS treatment category is not yet clear, given that injectables are starting to be squeezed out by new oral agents such as Biogen Idec’s own Tecfidera (dimethyl fumarate) – which is on course to make $3bn in sales this year – along with Novartis’ Gilenya (fingolimod) and Sanofi’s Lemtrada (teriflunomide).

Meanwhile, Biogen Idec is also in the roll-out phase for its Avonex follow-up Plegridy (peginterferon beta-1a), which became its fifth MS drug on the market after being approved by the US Food and Drug Administration (FDA) in July.

Biogen Idec’s executive vice president of global commercial operations Tony Kingsley said recently the combination of good efficacy and self-administered, once-monthly dosing – along with the fact that it has a different mechanism of action than other drugs on the market – will stand in its favour.

Plegridy is administered once every two weeks, while Avonex is given weekly.

With a proportion of patients switching from both injectable and oral drugs daclizumab provides “a package…that could have a meaningful place in the market,” he said.

Despite the encouraging efficacy, the safety data on the drug was not quite a home run, however, as earlier concerns about liver toxicity have not been laid to rest in the DECIDE trial, with some patients experiencing increases in liver enzyme levels. Others showed signs of skin reactions, according to the data.

Biogen Idec is also developing BIIB033, an anti-LINGO-1 antibody for MS, which is currently in trials to see if it can repair (re-myelinate) nerves in active relapsing MS patients.

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