Unlock stock picks and a broker-level newsfeed that powers Wall Street.

Korro Announces Regulatory Filing for Initiation of KRRO-110 First-In-Human Study and Formation of Clinical Advisory Board

In This Article:

Korro Bio, Inc.
Korro Bio, Inc.

-Regulatory filing of Phase 1/2 clinical study for Alpha-1 Antitrypsin Deficiency (AATD) submitted to Australian Bellberry Human Research Ethics Committee (HREC)

-Clinical Advisory Board of lung and liver experts formed to support development of KRRO-110

-First participant dosing anticipated in first quarter of 2025

-Interim readout expected in second half of 2025 and completion of Phase 1/2 study anticipated in 2026

CAMBRIDGE, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a biopharmaceutical company focused on developing a new class of genetic medicines based on editing RNA for both rare and highly prevalent diseases, today announced a submission to the Bellberry HREC for a Phase 1/2 clinical study of KRRO-110 for AATD. A Clinical Advisory Board (CAB) comprised of distinguished lung and liver researchers and experts in AATD has also been assembled to help guide the clinical development strategy for KRRO-110.

“This regulatory filing reflects Korro’s transition to a clinical-stage company, and another important milestone in the development of KRRO-110,” said Kemi Olugemo, MD, Chief Medical Officer at Korro. “There remains significant unmet medical need for people living with AATD, and based on our preclinical data, KRRO-110 has the potential to be a best-in-class therapy given our differentiated approach for RNA editing. The breadth of pulmonary and hepatic expertise in our CAB will be invaluable to our clinical and regulatory strategy, ensuring we consider the holistic needs of patients with AATD. We are honored to work alongside the world's leading experts in AATD who share our commitment to scientific excellence and improving patient outcomes.”

Subject to approval by the HREC and acceptance of the clinical trial notification (CTN) by Australia’s Therapeutic Goods Administration (TGA), Korro anticipates dosing the first participant in the Phase 1/2 study in the first quarter of 2025. An interim data readout for the Phase 1/2 study of KRRO-110 is anticipated in the second half of 2025, and completion of the study is expected in 2026.

“This is a major achievement for a company founded on RNA editing – to go from initial concepts and ideas to a first-in-human clinical study. I am immensely proud of the progress we have made since nomination of KRRO-110 for AATD in December 2023 and the contributions of the entire team at Korro,” added Ram Aiyar, PhD, CEO and President of Korro. “Our robust pipeline of fully owned and partnered programs showcases the transformative potential of our OPERA™ platform. With a strong balance sheet to support completion of the Phase 1/2 study and to advance the next set of programs, I am excited to see the potential of our platform realized.”

Waiting for permission
Allow microphone access to enable voice search

Try again.