Shire, Xenetic see hemophilia A candidate flunk key test

Shire said it was disappointed by the new data.

Shire and drug partner Xenetic have released new data for their collaborative bleeding disorder drug SHP656, and the news isn’t good.

Despite Xenetic using the first 100 words of its press release to talk up the med’s data, the key sentence for investors reads: “In this study, a pre-defined once-weekly dosing criterion was not met.”

The phase 1/2 test, undertaken by partner Shire, was looking at SHP656 as a long-acting therapeutic for the treatment of hemophilia A. The med works by using Xenetic’s PolyXen platform tech, a system that conjugates polysialic acid to therapeutic blood-clotting factors and is designed to boost the half-life of a drug.

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There were no drug-related adverse events, or serious adverse events in the study: but nor was there success.

“While Shire is disappointed by this outcome, the company is encouraged by the knowledge gained through this research and remains committed to transforming the treatment landscape for patients with bleeding disorders. Given the potential application of polysialic acid technology, the companies will explore future collaborations,” said Philip Vickers, Ph.D., global head of R&D at Shire.

M. Scott Maguire, Xenetic’s CEO, added: “Moving forward, we believe data from Shire’s SHP656 program continues to support the broad utility of our proprietary PolyXen technology platform, and we remain focused on building a growing pipeline of partnerships utilizing this proven platform. We truly value our continuing relationship with Shire and look forward to exploring other potential applications of PolyXen within the Shire portfolio.”