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Single dose of L9LS

Phase 2

Malaria | Monoclonal antibody | Infectious Disease |Harvard Bioscience, Inc.|Last Updated: Feb 17, 2026

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07060508L9LS in Women of Childbearing Potential in MaliPHASE2 RECRUITING 290Jul 22, 2025Apr 1, 2026Feb 17, 20263 Mali
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Study Endpoints
Primary Endpoints
Incidence of local and systemic adverse events (AEs)
Days 0, 1, 3, and 7.

Occurring within 7 days after the administration of study agent

Severity of local and systemic adverse events (AEs)
Days 0, 1, 3, and 7.

Occurring within 7 days after the administration of study agent

Incidence of laboratory abnormalities
Days 7 and 14.

Occurring within 14 days after the administration of study agent

Number of participants with treatment-related laboratory adverse events
Days 7 and 14.

Occurring within 14 days after the administration of study agent

Pf blood-stage infection as detected by microscopic examination of thick blood smear
Once every 2 weeks post injection through 24 weeks.
Secondary Endpoints
Pf blood-stage infection as detected by thick blood smear and RT-PCR
Blood smear once every 2 weeks post injection through 24 weeks.
Concentration of L9LS in sera of recipients.
Through 24 weeks.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
L9LS in healthy Malian WOCBPEXPERIMENTAL -
Placebo in healthy Malian WOCBPPLACEBO_COMPARATOR -
L9LS in healthy Malian adult malesEXPERIMENTAL -
Interventions
NameTypeDescription
Single dose of 1800 mg L9LS SCBIOLOGICALA human monoclonal antibody to protect against Plasmodium falciparum.
PlaceboOTHERNormal saline
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg. 2. Males aged ≥18 and ≤49 years (no weight restrictions). 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. In good general health and without...

Countries:Mali
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Competitive Landscape -Malaria 8 trials
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07060508studyFirstPostDate: changed