Sobi’s investigational gout therapy, pozdeutinurad, has been shown to meaningfully reduce levels of a key chemical that drives the disease in a late-stage trial, marking a positive step forward for the company as it awaits results from another Phase III study.
These positive results stem from the REDUCE-2 study (NCT06439602), where researchers randomised 811 patients with uncontrolled gout to receive either 50mg or 75mg of pozdeutinurad or placebo.
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As per late-breaking data presented at ACR Convergence 2026, pozdeutinurad met its primary endpoint – with 56.6% and 69.2% of patients achieving serum urate (SU) levels below 6mg/dL at the six-month mark in the low- and high- dose pozdeutinurad cohorts, versus 8.1% in the placebo arm. Researchers widely use SU, a bodily waste product, as a marker of disease severity in gout.
The selective URAT1 inhibitor’s beneficial effects were seen as early as month one following treatment initiation and were sustained over time, up to 12 months, with researchers observing clinically meaningful reductions in blood levels of the waste product with the once-daily, oral therapy.
Alongside its promising efficacy, patients generally tolerated pozdeutinurad well, with rates of treatment-emergent adverse events (TEAEs) remaining similar across the low-dose, high-dose and placebo arms at 60.7%, 61.7% and 60.9%, respectively.
These positive results will come as welcome news for the gout patient population, which continues to face significant unmet needs, said REDUCE-2 investigator, Puja Khanna.
“Achieving and maintaining target SU levels is fundamental to effective gout management, yet many patients remain inadequately controlled with currently available oral therapies, which can lead to permanent joint and tissue damage,” Khanna comments.
As pozdeutinurad has been shown to offer durable and clinically meaningful SU-lowering benefits, alongside a safety profile comparable to placebo, Khanna noted that the REDUCE-2 data supports the drug’s promise as a potential treatment option for patients with uncontrolled gout.
Next steps for pozdeutinurad
With these positive results in the bag, Sobi will now look ahead to the results of REDUCE-1, its other pivotal gout study on pozdeutinurad. If this readout is positive, the Swedish pharma could be poised to vie for the drug’s approval in uncontrolled gout.
If this pans out, pozdeutinurad would join a gout market primarily dominated by generic medicines, with only 2% of marketed therapies being innovator medicines, as per GlobalData’s Pharmaceutical Intelligence Center.
GlobalData is the parent company of Clinical Trials Arena.
Sobi is also hoping for market approval of its other investigational gout therapy, NASP (nanoencapsulated sirolimus plus pegadricase), though the therapy received an approval rejection from US regulators in June 2026. This is due to the US Food and Drug Administration’s (FDA) need to see additional chemistry, manufacturing and controls (CMC) data, as well as the need for the company to address certain contract manufacturing facility deficiencies.
Elsewhere in the gout development landscape, biotech Crystalys recently banked $130m in a Series B financing round to push its therapy, dotinurad, further down the pipeline, while gearing the drug up for commercialisation.
