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ADX-629

Phase 2

Covid19 | Small molecule | Infectious Disease |Aldeyra Therapeutics, Inc.|Last Updated: Feb 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04847544A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.PHASE2 COMPLETED 11Mar 31, 2021Oct 15, 2021Feb 17, 20251 United States
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Study Endpoints
Primary Endpoints
Number of Subjects With Serious Adverse Events
The safety assessment period was Days 1 - 28.

Safety was assessed through serious adverse event reporting.

Secondary Endpoints
Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale
The efficacy assessment period was 4 weeks; baseline was defined as Day 1 prior to first dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.EXPERIMENTAL -
Placebo administered orally BID for up to 28 days.PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ADX-629DRUGADX-629 administered orally twice daily (BID) for up to 28 days.
PlaceboDRUGPlacebo administered orally BID for up to 28 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Is a male or female greater than or equal to18 years of age at Screening; * Is willing and able to sign and date (or has a legally authorized representative willing to sign and date) a written (or electronic) informed consent form or provide equivalent consent per Food and Dru...

Countries:United States
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