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Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 CORAL-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis
Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations KB407 transduction confirmed in all six
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations KB407 transduction confirmed in all six patients with successful bronchoscopies irrespective of modulator-status; percentage of conducting airway cells transduced in each patient ranged from 29.4% to 42.1% Registrational repeat dosing CORAL-3 study design submitted to FDA in late December; anticipating enrollment in study to start in 1H 2026 following alignment with the FDA Investor call to be held January 8 at 4:30 pm ET to discuss data update and timelines for KB407 repeat dosing study start PITTSBURGH, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced a positive interim clinical update from the highest dose cohort of CORAL-1, the Company’s multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407. “Molecular confirmation of delivery and expression of unmodified, wild-type CFTR protein in clinically relevant ciliated and secretory cells of the lungs of patients with CF is a tremendous breakthrough and a first for our field,” said Jorge Lascano, MD, Professor of Medicine, Associate Director of the Adult Cystic Fibrosis Program, and Director of the Cystic Fibrosis Therapeutics Development Center at the University of Florida. “High rates of KB407 transduction and broad distribution across patient airways irrespective of underlying lung disease, genetic background, or modulator status – combined with the redosability of KB407 and demonstrated functionality of its full-length CFTR payload – underscore the transformative potential of KB407 as a mutation-agnostic therapy for the many patients either ineligible for or underserved by currently availably modulators.” The Company will host an investor conference call and webcast today, Thursday, January 8, 2026, at 4:30 pm ET, to discuss the clinical data updates. Investors and the general public can access the live webcast at: https://www.webcaster5.com/Webcast/Page/3018/53466. For those unable to listen to the live webcast, an archived version will also be available on the Investors section of the Company’s we...