Company: SION
Filing Date: 2025-02-03
Form Type: S-1/A
Source: 0001193125-25-018825
Chunk: 182

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-03
Form: S-1/A
Chunk 182
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| • |     | The mean absolute change from baseline in ppFEV1 from baseline                                                                                                                                                                           
 through Day 29 ranged from -0.1 to 3.5 percentage points for the five dual combination dose groups (navocaftor 150mg and galicaftor across a range of doses). The least squares means (“LS means”) change from baseline in ppFEV1 was    
 statistically significant in the 200mg and 300mg galicaftor combination groups, 3.5 ppFEV1 (p<0.05) and 3.1 ppFEV1 (p<0.05),                                                                                                             
 respectively. These data are from the analysis in which all spirometry values were used, regardless of usage status of bronchodilator or airway clearance regimen before spirometry collection. LS means with standard errors (“SE”) and 
 p-values are from mixed-effect model repeat measures analysis.                                                                                                                                                                           |

| • |     | AbbVie also assessed sweat chloride improvement as a secondary efficacy endpoint. Mean SwCl improvement occurred in all                              
 groups with galicaftor 30 mg or higher, with improvement of 18.6 mmol/L in the 200 mg group (p<0.001) and 19.9 mmol/L in the 300 mg group (p<0.001). |

| • |     | Galicaftor was generally well-tolerated in combination with navocaftor in this trial. Most reported AEs were mild to                                                                                                                           
 moderate in severity. Two serious adverse events (“SAEs”) occurred in two subjects receiving galicaftor in combination with navocaftor (ileus and cholecystitis acute); both were considered unrelated to the trial drugs by the investigator. |

| • |     | Trial GLPG-2222-CL-202 was a Phase 2 dose-ranging trial conducted by Galapagos in Europe and the U.S. to evaluate the                                                                                                                      
 safety and tolerability and the effect on CFTR function (as assessed by sweat chloride), pulmonary function and the Cystic Fibrosis Questionnaire—Revised (“CFQ-R”), which measures health-related quality of life, of galicaftor in 59 CF 
 patients that were homozygous for F508del mutation. The trial was completed in October 2017.                                                                                                                                               |

| • |     | Four doses of galicaftor were tested in this trial (50 mg,