Drugs / ASVASIRAN SODIUM
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00496821 | Jul → Nov 2007 | respiratory syncytial virus infectious disease | Alnylam Pharmaceuticals | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT01065935 Comparator | Feb 2010 → Apr 2012 | respiratory syncytial virus infectious disease | Alnylam Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00658086 Comparator | Apr 2008 → Apr 2009 | respiratory syncytial virus infectious disease | Alnylam Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2012-09-04 | Alnylam Pharmaceuticals | Results Alnylam Presents Complete Results from Phase IIb Trial with ALN-RSV01, an Inhaled RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today complete results from its Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients. |
| 2012-05-30 | Alnylam Pharmaceuticals | Results Alnylam Announces Top-Line Results of Phase IIb Clinical Trial of ALN-RSV01, an Inhaled RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection alnylam.com ↗
The study missed the primary endpoint of reduced BOS in an “intent-to-treat” (ITTc) analysis of confirmed RSV infected patients (p=0.058), but achieved statistically significant reductions in prospectively defined analyses of ITTc patients with their “last observation carried forward” (LOCF) with a p-value of 0.028, and of ITTc patients treated “per protocol” (PP) with a p-value of 0.025. |
| 2010-09-29 | Alnylam Pharmaceuticals | Results Alnylam Publishes Results from Phase IIa Study of ALN-RSV01 in the Treatment of Respiratory Syncytial Virus Infection in Lung Transplant Patients alnylam.com ↗
The results also demonstrated statistically significant improvements in clinical symptom scores and reductions in the incidence of bronchiolitis obliterans syndrome (BOS), an irreversible and life-threatening complication of RSV infection in lung transplant patients resulting in approximately 50% mortality within three to five years of onset. |
| 2010-04-27 | Alnylam Pharmaceuticals | Results Alnylam Publishes Results from Phase II GEMINI Trial with ALN-RSV01 alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has published results from its Phase II GEMINI study in the Proceedings of the National Academy of Sciences (PNAS) (DOI: 10.1073/pnas.0912186107). |
| 2009-07-20 | Alnylam Pharmaceuticals | Results Alnylam and Cubist Announce Complete Data from Phase II Study of ALN-RSV01 in Lung Transplant Patients Naturally Infected with Respiratory Syncytial Virus alnylam.com ↗ |
| 2009-06-08 | Alnylam Pharmaceuticals | Results Alnylam and Cubist Report Preliminary Data from Phase II Study of ALN-RSV01 in Lung Transplant Patients Naturally Infected with Respiratory Syncytial Virus alnylam.com ↗
Overall, the study achieved its primary objective of demonstrating safety and tolerability of ALN-RSV01 over 30 days post treatment. |
| 2008-02-29 | Alnylam Pharmaceuticals | Results Alnylam Achieves First Human Proof of Concept for an RNAi Therapeutic with GEMINI Study alnylam.com ↗
Results from the company's GEMINI trial with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV), showed statistically significant anti-viral efficacy. |
| 2008-01-23 | Alnylam Pharmaceuticals | Results Alnylam Reports Positive Phase II Data for ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection alnylam.com ↗
Top-line results show that ALN-RSV01 was safe and well tolerated and demonstrated statistically significant anti-viral activity. |
| 2007-12-13 | Alnylam Pharmaceuticals | Results Alnylam Reports Continued Progress in Clinical Development of ALN-RSV01 for the Treatment of Respiratory Syncytial Virus (RSV) Infection alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced the presentation of results from its Phase I trial with ALN-RSV01 delivered via inhalation at the 18th Annual Drug Delivery to the Lungs meeting being held in Edinburgh, U.K. |
| 2007-05-07 | Alnylam Pharmaceuticals | Results Alnylam Reports Results of Human Experimental Infection Model with Respiratory Syncytial Virus alnylam.com ↗
72 percent of subjects were infected with a mean incubation period of 3.2 days, duration of infection of 7 days, and viral load (by an area under the curve analysis) of 61.9 log 10 |
| 2006-04-30 | Alnylam Pharmaceuticals | Results Alnylam Reports Phase I Clinical Safety Data for ALN-RSV01, an RNAi Therapeutic for the Treatment of RSV Infection; Results Reported at the 2006 Pediatric Academic Societies' Annual Meeting alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the company's lead product candidate, ALN-RSV01, was found to be safe and well tolerated when administered intranasally in two Phase I clinical studies. |
| 2005-11-01 | Alnylam Pharmaceuticals | Regulatory Alnylam Submits IND Application for ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection; Represents First RNAi Therapeutic for Viral Infectious Diseases and Alnylam's Lead Clinical-Stage Program alnylam.com ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a human clinical trial of ALN-RSV01, its proprietary RNAi therapeutic for the treatment of patients with respiratory syncytial virus (RSV) infection. |
| 2005-03-18 | Alnylam Pharmaceuticals | Results In Vivo Efficacy Data Presented from Alnylam RSV Program at the American Academy of Allergy, Asthma and Immunology Meeting alnylam.com ↗
Pre-clinical studies performed in mice demonstrated that a single low dose of ALN-RSV01 (2 mg/kg) protected against subsequent RSV infection. |
All press releases naming this drug 25 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASVASIRAN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137338 ↗ |
| Known as | ALN-RSV01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01065935 ↗ |
| Action | Inhibit | “ALN-RSV01 is a small interfering RNA targeting RSV replication.” PMID 20851929 ↗ Sep 2010 |
| Modality | Small interfering RNA (siRNA) | “ALN-RSV01 is a small interfering RNA targeting RSV replication.” PMID 20851929 ↗ Sep 2010 |
| Route | Intranasal | “The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo” NCT00496821 ↗ |