Rezolute receives EMA PRIME eligibility for RZ358 in congenital hyperinsulinism

Rezolute, Inc.

EMA grants PRIME eligibility to RZ358 for congenital HI, citing unmet medical need and positive Phase 2b data.
PRIME provides enhanced regulatory support to accelerate development and evaluation.
Phase 3 study for RZ358 planned to initiate in Q4 2023.
Phase 2b RIZE study showed ~75% average improvement in hypoglycemia at intended Phase 3 doses.
Improvement was consistent across age groups (2-6, 6-12, >12 years).

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