Selecta and Sobi Report P-III Trial (DISSOLVE I & II) Results of SEL-212 for Chronic Refractory Gout
Shots:
- The P-III trial (DISSOLVE I & II) evaluates 2 dose levels of SEL-212 vs PBO in adult patients. Both trials met its 1EPs i.e., patients who received monthly doses of SEL-212 achieved a response at high & low doses (0.15 & 0.1mg/kg) in the (DISSOLVE I) trial (56% & 48% vs 4% in PBO); 47% & 41% vs 12% in (DISSOLVE II) trial at 6mos.
- At both doses, the response rate in patients aged ≥50yrs was 65% & 47% in (DISSOLVE I) and 48% & 45% in (DISSOLVE II) over 14% in PBO with a 69% reduction in mean SU levels at 0.15mg/kg in (DISSOLVE I) trial
- The therapy showed a favorable safety profile & was well-tolerated across both doses with 3.4% of patients with infusion reactions at high doses. Regulatory submission in the US is expected in H1’24
Ref: Globenewswire | Image: Mynewsdesk
Related News:- Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gou
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