KRRO-110 / Korro Bio - LARVOL DELTA

REWRITE: A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110 (clinicaltrials.gov) - P1/2 | N=64 | Active, not recruiting | Sponsor: Korro Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alpha-1 Antitrypsin Deficiency • Genetic Disorders • Pulmonary Disease • Respiratory Diseases

Korro Receives European Medicines Agency Orphan Drug Designation for KRRO-110 (The Manila Times) - "Korro Bio, Inc...announced today that it has been granted orphan drug designation by the European Medicines Agency (EMA) Committee, who adopted a positive opinion on KRRO-110, Korro’s investigational medicine for the treatment of Alpha-1 Antitrypsin Deficiency (AATD)...In March 2025, KRRO-110 received orphan drug designation from the U.S. Food and Drug Administration for the treatment of AATD. KRRO-110 is currently being evaluated in the Phase 1/2a REWRITE clinical study for AATD, and an interim readout is expected in the second half of 2025."

CHMP • Orphan drug • Alpha-1 Antitrypsin Deficiency

Korro Reports Full Year 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "Upcoming Milestones: Interim readout from Phase 1/2a REWRITE clinical study of KRRO-110 for AATD expected in the second half of 2025, and completion of the REWRITE clinical study expected in 2026. Korro expects to nominate a development candidate for its rare metabolic disorder program targeting the liver (GalNAc) with subcutaneous delivery to create de novo protein variants by the end of 2025....Cash runway into the second half of 2026 expected to fund KRRO-110 through completion of the Phase 1/2a REWRITE clinical study and progress additional product candidates."

Commercial • New molecule • P1/2 data • Trial completion date • Alpha-1 Antitrypsin Deficiency

KRRO-110 Receives Orphan Drug Designation from U.S. FDA for Alpha-1 Antitrypsin Deficiency (GlobeNewswire) - "Korro Bio, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational medicine KRRO-110 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD)...Dosing of the first two single ascending dose cohorts in healthy adult volunteers has been completed, and an interim readout is expected in the second half of 2025."

Orphan drug • P1/2 data • Alpha-1 Antitrypsin Deficiency

Korro Bio Announces Dosing of First Participants in REWRITE Phase 1/2a Study of KRRO-110 for Alpha-1 Antitrypsin Deficiency and Provides Pipeline Update (GlobeNewswire) - "Secondary and exploratory endpoints include pharmacokinetic and pharmacodynamic parameters that will guide optimal dose selection for later stage studies. Interim data from Part 1 (single ascending doses in healthy volunteers and individuals with AATD) is expected in the second half of 2025, and completion of the study is anticipated in 2026....In addition to advancing KRRO-110, Korro is progressing a pipeline of wholly owned programs and a Novo Nordisk partnered program in a cardiometabolic indication towards the clinic."

P1/2 data • Trial status • Alpha-1 Antitrypsin Deficiency