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OVX836 480µg

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Harmony Biosciences Holdings, Inc.|Last Updated: Oct 31, 2024

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 Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05284799Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.PHASE2 COMPLETED 180 — — May 9, 2022Dec 9, 2022Oct 31, 20241 Australia
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Study Endpoints
Primary Endpoints
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29 versus pre-injection baseline (Day 1)

Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.

Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
During 7 days after vaccine administration
Proportion of subjects reporting unsolicited AEs
During 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases
During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
During the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
During the whole study duration, 180 days
Secondary Endpoints
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine.
At Day 1 (pre-injection baseline) and Day 29
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
At Day 1, Day 8 and Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial doseEXPERIMENTALOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.
Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + PlaceboACTIVE_COMPARATORFluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1
OVX836 480µg + PlaceboPLACEBO_COMPARATOROVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1
Interventions
NameTypeDescription
OVX836 480µgBIOLOGICALOne single administration intramuscularly at Day 1
Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)BIOLOGICALOne single administration intramuscularly at Day 1
PlaceboBIOLOGICALOne single administration intramuscularly at Day 1
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written informed consent. 2. Healthy male or female subjects, as determined by medical history and medical examination. 3. Between the age of 18 and 55 years, inclusive. 4. Subjects who have fully been vaccinated with licensed Severe Acute Respiratory Syndrome Coronavirus-2 (...

Countries:Australia
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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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