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ALN-RSV01

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment199

FDA Designations

No designations recorded

Clinical trial landscape

ALN-RSV01 · 3 trials · 1 indication

Phase 2 3
NCT01065935Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)Respiratory Syncytial Virus Infections
COMPLETED87 Analytics
NCT00658086Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)Respiratory Syncytial Virus Infections
COMPLETED24 Analytics
NCT00496821Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial VirusRespiratory Syncytial Virus Infections
COMPLETED88 Analytics
PHASE2COMPLETED
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Respiratory Syncytial Virus InfectionsUnlock trial analytics
PHASE2COMPLETED
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Respiratory Syncytial Virus InfectionsUnlock trial analytics
PHASE2COMPLETED
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Respiratory Syncytial Virus InfectionsUnlock trial analytics

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 to 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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Frequently asked questions about ALN-RSV01

What is ALN-RSV01 used for?

ALN-RSV01 is an investigational drug being studied for the treatment of Respiratory Syncytial Virus (RSV) infections. It has been evaluated in clinical trials involving adult volunteers and lung transplant patients infected with RSV. The drug is administered intranasally and is currently in Phase 2 clinical development.

Who makes ALN-RSV01?

ALN-RSV01 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY. The company has conducted multiple clinical trials to evaluate the safety and efficacy of ALN-RSV01 in patients with Respiratory Syncytial Virus infections.

What phase is ALN-RSV01 in?

ALN-RSV01 is in Phase 2 clinical development. It has completed three Phase 2 trials, including a Phase 2b study in lung transplant patients infected with Respiratory Syncytial Virus. The drug is investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is ALN-RSV01 in?

ALN-RSV01 has been studied in three completed Phase 2 clinical trials. These include NCT00496821, a study in adult volunteers experimentally inoculated with RSV; NCT00658086, a Phase 2 study in lung transplant patients with RSV; and NCT01065935, a Phase 2b study in lung transplant patients with RSV. All trials have been completed.

Is ALN-RSV01 the same as other RSV treatments?

ALN-RSV01 is a distinct investigational drug being developed specifically for Respiratory Syncytial Virus infections. It is not known to be the same as any other marketed RSV treatment. Its development is focused on evaluating its potential as a therapeutic option for RSV, particularly in lung transplant patients.