Shots:
- Rezolute has completed pts enrollment in P-III (sunRIZE/RZ358-301) trial of ersodetug as an add-on treatment of hypoglycemia in congenital hyperinsulinism pts, with 62 pts enrolled, exceeding the target of 56; the US FDA’s BLA filing is expected in 2026
- Trial assessed ersodetug (5 or 10mg/kg, Q2W during initial loading then Q4W for 6mos.) + SoC vs PBO + SoC in pts (3mos. to 45yrs.) with congenital hyperinsulinism; pts could then opt for an OLE phase
- Trial will evaluate change in average weekly hypoglycemia events from baseline as the 1EP & average percent time spent in hypoglycemia as the 2EP; topline data is anticipated in Dec 2025
Ref: Globenewswire| Image: Rezolute| Press Release
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