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SION-451

Phase 1

Cystic Fibrosis (CF) | Small molecule | Respiratory |Sionna Therapeutics, Inc.|Last Updated: Sep 3, 2025

Target and mechanism

Molecular targetCFTR
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment144

FDA Designations

No designations recorded

Clinical trial landscape

SION-451 · 1 trial · 1 indication

Phase 1 1
NCT07035990Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.Cystic Fibrosis (CF)
RECRUITING144 Analytics
PHASE1RECRUITING
Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.
Cystic Fibrosis (CF)Unlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-109 when administered in combination to healthy participants
From Day 1 through day 21

Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.

To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-2222 when administered in combination to healthy participants
From Day 1 through day 21

Adverse events to the study drug combination SION-451 and SION-2222 will be measured

Secondary Endpoints

Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
From Day 1 through day 17
Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
From Day 1 through day 17
AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
From Day 1 through day 17
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SION-451 + SION-2222EXPERIMENTALAll participants who receive SION-451 in combination with SION-2222
Placebo matched to SION-451 and SION-2222PLACEBO_COMPARATOR -
SION 451 + SION 109EXPERIMENTALAll participants who receive SION-451 in combination with SION-109
Placebo matched to SION-451 and SION-109PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SION-451DRUG* Pharmaceutical form: tablet * Route of administration: oral
SION-2222DRUG* Pharmaceutical form: capsule * Route of administration: oral
SION-109DRUG* Pharmaceutical form: tablet * Route of administration: oral
Placebo SION-451DRUGPlacebo matched to SION-451
Placebo SION-2222DRUGPlacebo matched to SION-2222
Placebo SION-109DRUGPlacebo matched to SION-109
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

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...

Countries:Australia
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Competitive Landscape -Cystic Fibrosis 17 trials (matched to "Cystic Fibrosis (CF)")

Frequently asked questions about SION-451

What is SION-451 used for?

SION-451 is an investigational small molecule being developed for the treatment of Cystic Fibrosis (CF). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in combination with other modulators to potentially address the underlying cause of the disease.

What does SION-451 target?

SION-451 targets the CFTR protein, which is defective in people with Cystic Fibrosis. By modulating this protein, the drug aims to restore its function, potentially improving chloride transport and reducing the symptoms associated with the disease. This mechanism is being evaluated in early-stage clinical trials.

Who is developing SION-451?

SION-451 is being developed by Sionna Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol SION. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of the drug in healthy participants and individuals with Cystic Fibrosis.

What phase is SION-451 in?

SION-451 is in Phase 1 clinical development. The drug is currently being studied in a randomized, double-blind, placebo-controlled trial to assess its safety, tolerability, and pharmacokinetics. It is an investigational agent and has not yet received regulatory approval for any indication.

What clinical trials is SION-451 in?

SION-451 is being evaluated in a Phase 1 clinical trial with the identifier NCT07035990. This study is recruiting 144 healthy participants in Australia and is investigating multiple dose combinations of SION-451 with complementary modulators SION-2222 and SION-109. The trial is randomized, double-blind, and placebo-controlled.

Is SION-451 the same as SION-2222 or SION-109?

No, SION-451 is a distinct investigational drug from SION-2222 and SION-109. These are separate complementary modulators being studied in combination with SION-451 in a clinical trial. Each agent has its own unique properties and is being evaluated together to assess their combined effects in treating Cystic Fibrosis.