Sionna Therapeutics Reports Data From Phase 1 Clinical Trials Of SION-719 And SION-451, First-In-Class NBD1 Stabilizers, In Healthy Volunteers

SION-719 and SION-451 were generally well tolerated and achieved desired pharmacokinetic targets that reinforce their potential as either an add-on to standard of care or in a Sionna dual combination

Sionna plans to advance SION-719 to a Phase 2a proof-of-concept add-on to standard of care trial in cystic fibrosis patients, and SION-451 to a Phase 1 healthy volunteer dual combination trial

Next trials to initiate in the second half of 2025 with topline data expected in mid-2026

Sionna to hold a conference call today at 8:00 a.m. ET

WALTHAM, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (NASDAQ:SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that normalize the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein, today announced positive data from its Phase 1 clinical trials of SION-719 and SION-451, the company's first-in-class nucleotide-binding domain 1 (NBD1) stabilizers, in healthy volunteers. Both NBD1 stabilizers were generally well tolerated and achieved pharmacokinetic (PK) concentration targets established using Sionna's preclinical CF human bronchial epithelial (CFHBE) model. These data reinforce the potential of both NBD1 stabilizers to provide clinically meaningful benefit for CF patients, including the potential for wild-type CFTR function, either as an add-on to standard of care (SOC), or in a proprietary dual combination with complementary modulators. Sionna plans to advance both NBD1 stabilizers to the next stage of clinical development — SION-719 to a Phase 2a proof-of-concept (POC) trial in CF patients as an add-on to SOC, and SION-451 to a Phase 1 proprietary dual combination trial in healthy volunteers.