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SION-451 · 1 trial · 1 indication
Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.
Adverse events to the study drug combination SION-451 and SION-2222 will be measured
| Arm | Type | Description |
|---|---|---|
| SION-451 + SION-2222 | EXPERIMENTAL | All participants who receive SION-451 in combination with SION-2222 |
| Placebo matched to SION-451 and SION-2222 | PLACEBO_COMPARATOR | - |
| SION 451 + SION 109 | EXPERIMENTAL | All participants who receive SION-451 in combination with SION-109 |
| Placebo matched to SION-451 and SION-109 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SION-451 | DRUG | * Pharmaceutical form: tablet * Route of administration: oral |
| SION-2222 | DRUG | * Pharmaceutical form: capsule * Route of administration: oral |
| SION-109 | DRUG | * Pharmaceutical form: tablet * Route of administration: oral |
| Placebo SION-451 | DRUG | Placebo matched to SION-451 |
| Placebo SION-2222 | DRUG | Placebo matched to SION-2222 |
| Placebo SION-109 | DRUG | Placebo matched to SION-109 |
Inclusion Criteria: 1. Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent. 2. Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. Participant is willing to abstain from alcohol, caffeine, smoking and nic...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
SION-451 is an investigational small molecule being developed for cystic fibrosis, a respiratory disease. It is designed to be used in combination with complementary modulators SION-2222 and SION-109. Sionna Therapeutics is evaluating the combination in clinical trials, and SION-451 has not been approved for any use.
SION-451 targets CFTR, the cystic fibrosis transmembrane conductance regulator protein. CFTR dysfunction is the underlying cause of cystic fibrosis. By targeting this protein, SION-451 is intended to modulate CFTR activity as part of a combination regimen with SION-2222 and SION-109.
SION-451 is being developed by Sionna Therapeutics, Inc., which trades under the ticker SION. The company is advancing the compound for cystic fibrosis as part of a combination approach with its other modulators.
SION-451 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 program has evaluated the drug in healthy participants.
SION-451 has been studied in a Phase 1 trial, NCT07035990, titled Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants. The trial was completed, enrolled 120 participants, and was conducted in Australia.
No. SION-451, SION-2222, and SION-109 are distinct small molecule modulators developed by Sionna Therapeutics. They are studied together as a combination regimen, but each is a separate investigational compound.