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Good news for AZ on gout candidate lesinurad

Phase III trial backs planned filing in 2014
AstraZeneca AZ headquarters London UK

AstraZeneca's (AZ) candidate treatment for gout - lesinurad - has met its objectives in a phase III trial and remains on track for filing next year.

The LIGHT study looked at the role of lesinurad in the management of patients with gout who are unable to be treated with xanthineoxidase inhibitors such as allopurinol and febuxostat, sold by Takeda as Uloric and Ipsen as Adenuric.

Gout is an excruciatingly painful condition in which uric acid crystals are deposited in the joints, creating symptoms similar to an acute arthritis flare.

Lesinurad is the lead compound in a new class of gout treatments called selective uric acid re-absorption inhibitors (SURIs), which tackle gout by encouraging uric acid excretion from the body and reducing serum uric acid (sUA). AZ acquired the drug as part of its $1bn takeover of Ardea Biosciences last year.

In the LIGHT trial, lesinurad met the primary endpoint of a statistically significant increase in the proportion of patients meeting an sUA goal of less than 6.0mg/dL after six months treatment compared to placebo.

AZ's chief medical officer Briggs Morrison said the data are encouraging in the "small population of patents who can't take xanthine oxidase inhibitors." The company has three other phase III studies ongoing that are testing the use of the drug alongside allopurinol and febuxostat, and these should generate results in the middle of 2014.

Despite affecting some 15 million people in the developed world, gout remains a fairly small market for the pharma industry at around $500m in 2011, although it is tipped to grow rapidly as new treatment options are launched.

Decision Resources is predicting that the market will reach around $1bn in the US, Japan and the largest EU markets (France, Germany, Italy, Spain and the UK), with lesinurad and BioCryst's purine nucleoside phosphorylase (PNP) inhibitor ulodesine expected to drive growth.

Of the two, lesinurad is expected to be the market leader by 2018 as it has a more favourable safety profile than existing drugs, according to the market research firm.

Despite lying dormant in terms of new therapies for decades, gout is not an automatic success indication for pharma. Another company with high expectations - Savient Pharma - was forced to file for bankruptcy protection in October after sales of its gout treatment Krystexxa (pegloticase) remained stubbornly low despite being launched in 2011.

Krystexxa's poor performance has been attributed to its high price and tendency to induce neutralizing antibodies which limit the duration of effect.

Article by
Phil Taylor

13th December 2013

From: Research



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