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Coversin

Phase 2

Paroxysmal Nocturnal Hemoglobinuria (PNH) | Small molecule | Other |Akari Therapeutics Plc|Last Updated: May 4, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03427060Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 PolymorphismsPHASE2 COMPLETED 1 — — May 14, 2018Feb 3, 2021May 4, 20251 United States
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Study Endpoints
Primary Endpoints
Measurement of Serum Lactate Dehydrogenase (LDH)
Baseline to Day 186

Measurement of serum lactate dehydrogenase (LDH)

Secondary Endpoints
Percentage Change in Haemoglobin (Hb) Compared to Screening
Baseline to Day 186
Number of Packed Red Blood Cells (PRBC) Transfusions
Baseline to Day 180
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Coversin treatmentEXPERIMENTALCoversin - 22.5mg followed by 45mg for 6 months.
Interventions
NameTypeDescription
CoversinDRUGCoversin - 22.5mg followed by 45mg for 6 months.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with known PNH. 2. Aged 18 and above. No upper age limit. 3. Lactate dehydrogenase (LDH) ≥1.5 upper limit of normal. 4. Must agree to use two methods of contraception that are ≥99% effective in preventing pregnancy. 5. Resistance to eculizumab (Soliris®). 6. Voluntar...

Countries:United States
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