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ALN-RSV01

Phase 2

Respiratory Syncytial Virus Infections | Small molecule | Respiratory |Alnylam Pharmaceuticals, Inc.|Last Updated: Feb 5, 2018

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_CONTROLLEDDMC
Total Trials3
Total Enrollment199
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01065935Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)PHASE2 COMPLETED 87 — — Feb 1, 2010May 1, 2012Feb 5, 201833 United States, Australia +4
NCT00658086Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)PHASE2 COMPLETED 24 — — Apr 1, 2008Jun 1, 2009Jan 29, 201813 United States, Australia
NCT00496821Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial VirusPHASE2 COMPLETED 88 — — Jul 1, 2007Nov 1, 2007Nov 30, 20071 United States
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Study Endpoints
Primary Endpoints
The occurrence of new or progressive BOS grade 0p through 3 in RSV-infected lung transplant recipients
180 days after randomization
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
Day 30
Safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus
28 days
Secondary Endpoints
Proportion of patients with FEV1 >80% of pre-infection baseline value
90 and 180 days after randomization
RSV symptoms as measured by mean cumulative daily total symptom score
14 days after randomization
Viral load as measured by viral area under the curve (AUC)
6 days after randomization
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-RSV01ACTIVE_COMPARATOR -
Normal salinePLACEBO_COMPARATOR -
1ACTIVE_COMPARATORALN-RSV01
2PLACEBO_COMPARATORNormal saline
Interventions
NameTypeDescription
ALN-RSV01DRUGAdministered by nebulization once daily for 5 days
Normal SalineDRUGAdministered by nebulization once daily for 5 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Single or bilateral lung transplant recipients * Confirmed RSV infection * Greater than 90 days post current lung transplant * Rejection free for a minimum of 30 days Exclusion Criteria: * Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosi...

Countries:United StatesAustraliaAustriaCanadaFranceGermany
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