Setrusumab OI trials on track; alvelestat FDA alignment; leflutrozole licensed for up to $64.25M

Mereo BioPharma Group plc

Setrusumab: Phase 3 Orbit study (195 patients) expected full enrollment around end Q1 2024; Cosmic study (~65 patients) expected full enrollment 1H 2024.
Phase 2 data showed 67% reduction in annualized fracture rate; additional data expected 2024.
Alvelestat: FDA aligned on Phase 3 design with SGRQ Total Score as primary endpoint; could support full U.S. approval.
Leflutrozole: global license deal with ReproNovo; Mereo received upfront payment and up to $64.25M in milestones plus tiered royalties.
Cash runway guidance reaffirmed: existing cash expected to fund operations into 2026.

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