Drugs / ARC-520
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02535416 | Sep 2015 → Aug 2016 | — | Arrowhead Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01872065 | Jul 2013 → Sep 2014 | — | Arrowhead Pharmaceuticals | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT02738008 | Mar → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02577029 | Dec 2015 → Dec 2016 | hepatitis B virus infection, hepatitis D virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02604212 | Nov 2015 → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT02604199 | Sep 2015 → Jan 2017 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT02452528 | Aug 2015 → Dec 2016 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02349126 | Feb → Dec 2015 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT02065336 | Mar 2014 → Jan 2017 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2018-04-11 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents ARC-520 Clinical Data at The International Liver Congress™ arrowheadpharma.com ↗
A single dose of ARC-520 in combination with ETV reduced HBsAg for up to 44 weeks |
| 2018-03-28 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Announces Multiple Presentations at The International Liver Congress™ arrowheadpharma.com ↗
RNA interference therapy with ARC-520 Injection results in long term off-therapy antigen reductions in treatment naïve, HBeAg positive and negative patients with chronic HBV |
| 2017-12-06 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Clinical Data Demonstrating a Sustained Host Response in Hepatitis B Patients Following RNAi Therapy arrowheadpharma.com ↗
A maximum reduction from baseline in HBV surface antigen (HBsAg) of 5.0 log10 was achieved seven months following the administration of the last dose of ARC-520, with the lowest absolute level observed being just above the lower limit of HBsAg quantitation. |
| 2017-09-27 | Arrowhead Pharmaceuticals | Results Arrowhead Data Reveal Important Considerations for Future Hepatitis B Treatment arrowheadpharma.com ↗
These studies demonstrated that HBV DNA integrated into the host genome is an under-appreciated source of HBV surface antigen (HBsAg), a key protein implicated in maintaining chronic HBV infection. |
| 2017-04-20 | Arrowhead Pharmaceuticals | Results Arrowhead Presents ARC-520 and ARC-521 Clinical Data at The International Liver Congress™ arrowheadpharma.com ↗
We saw reductions in hepatitis B surface antigen, or HBsAg, of up to 3 logs following multiple doses with ARC-520 in combination with a NUC. |
| 2017-04-05 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Announces Presentations at The International Liver Congress™ arrowheadpharma.com ↗
Prolonged RNA interference therapy with ARC-520 Injection in treatment naïve, HBeAg positive and negative patients with chronic HBV results in significant reductions of HBs antigen |
| 2016-11-09 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Provides Update on Heparc-2004 Study arrowheadpharma.com ↗
Arrowhead was notified today verbally by the United States Food & Drug Administration (FDA) of its decision to place a clinical hold on Heparc-2004. |
| 2016-04-13 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents Promising ARC-520 Hepatitis B Data at The International Liver Congress™ 2016 arrowheadpharma.com ↗
There was a significant association between the development of an HBsAg Clearance Profile and ARC-520 therapy in HBV patients |
| 2015-12-07 | Arrowhead Pharmaceuticals | Results Arrowhead's ARC-520 Leads to Consistent Immune Reactivation in Chimpanzees with Chronic Hepatitis B Infection arrowheadpharma.com ↗
One chimpanzee also exhibited an on-treatment therapeutic ALT flare and sustained virologic improvements 31 weeks off all treatment. |
| 2015-11-16 | Arrowhead Pharmaceuticals | Results Arrowhead Late-Breaking Clinical Data Shows that ARC-520 Can Produce Deep and Durable Reductions of Hepatitis B Viral Antigens and DNA arrowheadpharma.com ↗
In this presentation, Dr. Yuen and co-authors show that in the Heparc-2001 clinical study, ARC-520 in combination with entecavir achieved maximum reductions of HBsAg, HBV DNA, HBeAg, and core-related antigen (HBcrAg) of 1.9 logs (99%), 4.3 logs (99.995%), 1.7 logs (98%), and 1.2 logs (93.7%), respectively. |
| 2015-11-15 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Data Showing Robust Sustained Anti-viral Effects with ARC-520 in Hepatitis B Infected Chimpanzees arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, presents data at the AASLD Liver Meeting 2015® in an oral presentation and a poster showing that ARC-520, its drug candidate against chronic hepatitis B infection (HBV), leads to robust, sustained anti-viral effects in chimpanzees with chronic HBV. |
| 2015-10-20 | Arrowhead Pharmaceuticals | Results Arrowhead Late-Breaker Abstract Accepted for Presentation at the AASLD Liver Meeting 2015 arrowheadpharma.com ↗
ARC-520 reduced HBeAg up to 1.7 log (mean max 1.2 log) |
| 2015-09-24 | Arrowhead Pharmaceuticals | Results Arrowhead Reports Peak Reduction in HBsAg of Up to 99% (1.9 log) After a Single Dose with Hepatitis B Candidate ARC-520 in Treatment Naïve Cohort of Phase 2a Study arrowheadpharma.com ↗
HBV E-antigen positive (HBeAg-positive) patients on a background of chronic entecavir receiving a 4 mg/kg single-dose of ARC-520 showed a mean maximal 92% (1.2 log) reduction in circulating HBeAg and a best reduction of 98% (1.7 log). |
| 2015-06-17 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Receives Regulatory Clearance to Begin Additional Phase 2b Studies of Hepatitis B Candidate ARC-520 arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that its Clinical Trial Application for ARC-520, its clinical candidate for chronic hepatitis B infection (HBV), has been approved by Germany's Federal Institute for Drugs and Medical Devices. |
| 2015-04-13 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-520 arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the United States Food and Drug Administration (FDA) informed the Company that it can proceed with a multiple-dose Phase 2b clinical study of ARC-520, its clinical candidate for the treatment of chronic hepatitis B infection, under an investigational new drug (IND) application previously filed with the FDA. |
| 2015-01-12 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Provides Update on IND for ARC-520 Phase 2b Study arrowheadpharma.com ↗
The FDA requested that the Company start the multiple-dose study at 1 mg/kg of ARC-520 rather than the proposed parallel study design of 2 and 4 mg/kg, and requested additional information be provided to the agency. |
| 2014-12-15 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Files IND for RNAi Therapeutic ARC-520 to Begin Phase 2b Multiple-Dose Studies in Chronic Hepatitis B Patients arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for ARC-520, it's drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. |
| 2014-11-10 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Data on ARC-520 and ARC-AAT at AASLD The Liver Meeting® 2014 arrowheadpharma.com ↗
ARC-520 shows statistically significant reduction in HBsAg through day 43 after a single injection (p < 0.05) |
| 2014-10-08 | Arrowhead Pharmaceuticals | Results Arrowhead to Present ARC-520 Phase 2a Data in Late-Breaking Session at AASLD Liver Meeting® 2014 arrowheadpharma.com ↗
Our ongoing Phase 2a dose finding study is an important step, and in cohort 1 at a dose of 1 mg/mg and cohort 2 at 2 mg/kg we saw a clear reduction in HBsAg, the surface antigen of HBV. |
| 2014-08-12 | Arrowhead Pharmaceuticals | Results Arrowhead Reports Fiscal 2014 Third Quarter Financial Results and Provides Update on ARC-520 arrowheadpharma.com ↗
Initial blinded data suggest that the magnitude of HBsAg knockdown is similar to non-human primate studies, including the chronically infected chimpanzee reported on previously |
| 2014-03-03 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Receives Regulatory Approval to Begin Phase 2a Trial of Chronic Hepatitis B Candidate ARC-520 arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it received regulatory approval to begin a Phase 2a clinical trial of ARC-520, its RNAi-based drug candidate for the treatment of chronic hepatitis B virus (HBV) infection. |
| 2013-12-09 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Phase 1 Data on ARC-520 at HepDART 2013 arrowheadpharma.com ↗
New data including pharmacokinetics (PK) and adverse event (AE) attribution presented today in a poster and in an oral presentation tomorrow, support the previous findings that ARC-520 appears to be generally safe and well-tolerated at all six dose levels studied. |
| 2013-11-25 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Submits Application to Begin Phase 2a Trial of ARC-520 for the Treatment of Chronic Hepatitis B Infection arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it recently filed an application for approval to begin a phase 2a clinical trial of its RNAi-based therapeutic candidate, ARC-520, for the potential treatment of chronic hepatitis B virus infection. |
| 2013-11-04 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Data Suggesting ARC-520 Induces Therapeutic Flare in Chronic Hepatitis B arrowheadpharma.com ↗
This is suggestive of a therapeutic immunological flare, which is thought to be part of a cascade that under chronic therapy may lead to HBsAg seroconversion and functional cure. |
| 2013-05-28 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Files to Begin Phase 1 Trial of RNAi Therapeutic ARC-520 Against Chronic Hepatitis B Infection arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced that it recently filed an application for approval to begin a phase 1 clinical trial of its RNAi-based therapeutic candidate, ARC-520, against chronic hepatitis B virus infection. |
| 2013-03-25 | Arrowhead Pharmaceuticals | Results Arrowhead Induces 90% Reduction in Hepatitis B Antigens in Chimpanzee with Chronic Infection: Data Follow Previous Report of Reduction in Viral DNA arrowheadpharma.com ↗
Arrowhead identified a well-tolerated dose of ARC-520 that lead to a 95% reduction in circulating viral DNA, and approximately 90% reductions in hepatitis e-antigen (HBeAg) and s-antigen (HBsAg), which are thought to be important in establishing a functional cure. |
| 2013-03-14 | Arrowhead Pharmaceuticals | Results Arrowhead RNAi Candidate ARC-520 Induces Greater than 90% Reduction in Circulating HBV DNA in Chimpanzee with Chronic Hepatitis B arrowheadpharma.com ↗
Arrowhead RNAi Candidate ARC-520 Induces Greater than 90% Reduction in Circulating HBV DNA in Chimpanzee with Chronic Hepatitis B |
| 2013-02-26 | Arrowhead Pharmaceuticals | Results Arrowhead Data Demonstrates RNAi Candidate ARC-520 Silences Hepatitis B Virus arrowheadpharma.com ↗
Arrowhead Research Corporation (NASDAQ: ARWR), a targeted therapeutics company, today announced the publication of data demonstrating multi-log reductions in hepatitis B viral DNA and proteins lasting over 30 days after a single injection in animal models. |
All press releases naming this drug 39 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARC-520 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01872065 ↗ |
| Known as | ARC-520 Injection | “ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism.” NCT02349126 ↗ |
| Action | Inhibit | “Treatment with ARC-520 for injection is expected to reduce all HBV proteins and replicative intermediates via ribonucleic acid (RNA) interference.” NCT02065336 ↗ |
| Route | Intravenous | “Single dose, intravenous administration of ARC-520.” NCT01872065 ↗ |