AstraZeneca dumps Amgen-partnered drug after midphase fail

AstraZeneca has dropped (PDF) Amgen-partnered autoimmune drug prezalumab from its pipeline. The action follows the failure of the anti-B7RP1 antibody in a midphase Sjöogren’s syndrome trial.

AstraZeneca secured the right to co-develop prezalumab, also known as AMG 557 and MEDI-5872, with Amgen through the multidrug deal it struck with the big biotech in 2012. Amgen remained the lead developer of the autoimmune prospect, putting it through a series of early-phase tests in lupus and psoriasis.

Prezalumab never advanced in those indications but did move into phase 2a in autoimmune disease Sjöogren’s syndrome in 2015. Now, AstraZeneca and Amgen have closed off that R&D avenue, too.

Amgen posted results from the phase 2a last month, revealing prezalumab failed to outperform placebo against a primary endpoint that tracked Sjogren’s syndrome disease activity. Prezalumab did no better than placebo against some of the secondary endpoints, either, leading Amgen to remove the candidate from its pipeline earlier this month. 

AstraZeneca has now followed suit, listing prezalumab among the casualties of its latest round of pipeline updates. The action marks the end of another of the five drugs covered by the 2012 deal. 

Abrilimumab, also known as AMG 181, fell by the wayside early, jettisoned from AstraZeneca’s pipeline in 2016 following the completion of midphase studies in Crohn’s disease and ulcerative colitis. The other three candidates covered by the deal live on, albeit in most cases with minimal involvement from Amgen or AstraZeneca.  

Having paid Amgen $50 million for a stake in the assets in 2012, AstraZeneca landed upfronts worth $100 million and $250 million from Valeant and Allergan, respectively. In 2015, AstraZeneca passed brodalumab on to Valeant, which subsequently brought it to market as Siliq. The next year, AstraZeneca offloaded the rights to IL-23 drug brazikumab, also known as AMG 139 and MEDI2070, to Allergan. Allergan began phase 2/3 trials of the drug in Crohn’s and ulcerative colitis last year. 

AstraZeneca has retained control of tezepelumab, formerly known as AMG 157, and worked with Amgen to move it into phase 2 and 3 trials in asthma and atopic dermatitis over the past two years, albeit on the back of less-than-stellar data in the latter indication. 

The clinical setbacks and outlicensing agreements have left AstraZeneca with a thin pipeline of non-respiratory autoimmune disease prospects. AstraZeneca is still testing anifrolumab, although the failure of the drug in a phase 3 lupus trial last year has dampened expectations. And it has a bispecific aimed at the same indication in phase 1. 

AstraZeneca’s latest pipeline cull also removed four phase 1 and 2 solid tumor prospects. The most advanced of the culled candidates were FGFR inhibitor AZD4547 and PI3k inhibitor AZD8186.

by Nick Paul Taylor

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