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DX-88

Phase 2

Hereditary Angioedema (HAE) | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 18, 2021

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
CONTROLLEDDMC
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01826916EDEMA2: Evaluation of DX-88's Effect in Mitigating AngioedemaPHASE2 COMPLETED 77Nov 1, 2003Jan 1, 2006May 18, 2021 -
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Study Endpoints
Primary Endpoints
Proportion of attacks treated with successful outcome
24 hours

successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours

Proportion of attacks with a partial response
24 hours

partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Secondary Endpoints
Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response
24 hours
Time to resolution onset of each acute attack, as determined by patient report
24 hours
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5mg/m2 DX-88 IVEXPERIMENTAL5mg/m2 DX-88 (ecallantide)administered intravenously
10mg/m2 DX-88 IVEXPERIMENTAL10mg/m2 DX-88(ecallantide)administered intravenously
20mg/m2 DX-88 IVEXPERIMENTAL20mg/m2 DX-88 (ecallantide) administered intravenously
30 mg DX-88 SCEXPERIMENTAL30mg DX-88(ecallantide)administered subcutaneously
Interventions
NameTypeDescription
DX-88 (ecallantide)DRUGsolution for injection 10 mg/mL
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 10 years of age or older * Documented diagnosis of HAE (Type I or II) * Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack * Willing and able to give informed consent Exclusion Criteria: * Patients with a serious i...

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