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ADS-8902

Phase 2

Influenza | Small molecule | Infectious Disease |Supernus Pharmaceuticals, Inc.|Last Updated: Apr 14, 2014

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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00979251Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised SubjectsPHASE2 COMPLETED 2 — — Sep 1, 2009Aug 1, 2011Apr 14, 201425 United States, Australia +3
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Study Endpoints
Primary Endpoints
Time to clearing of viral shedding
Baseline, Days 2, 4, 6, 8, 10, 15 and 20
Secondary Endpoints
Time to alleviation of influenza clinical symptoms
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza
Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment
Baseline, Days 2, 4, 6, 8, 10, 15, 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADS-8902EXPERIMENTALAmantadine and Ribavirin administered with Oseltamivir phosphate
ComparatorACTIVE_COMPARATOROseltamivir Phosphate
Interventions
NameTypeDescription
Oseltamivir PhosphateDRUGOseltamivir Phosphate, q8h
ADS-8902DRUGAmantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
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Eligibility Criteria
Age Range1 Year — 65 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Confirmed influenza A by rapid antigen testing * Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive * Cl...

Countries:United StatesAustraliaCanadaNetherlandsSingapore
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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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