Drugs / REP 2139
REP 2139
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02646189 | Aug 2011 → Aug 2013 | chronic hepatitis B virus infection | Replicor Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02565719 | Mar 2016 → May 2019 | chronic hepatitis B virus infection | Replicor Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02726789 | Oct 2012 → Sep 2016 | chronic hepatitis B virus infection | Replicor Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2023-11-13 | Replicor Inc. | Results Replicor updates REP 2139-Mg compassionate use and mechanistic data at AASLD 2023 replicor.com ↗
REP 2139 is a unique bifunctional agent which directly targets HDV replication and subviral particle assembly. |
| 2023-09-25 | Replicor Inc. | Results Replicor announces the description of direct acting activity of REP 2139 against HDV replicor.com ↗
This evolving dataset demonstrates a 10-fold reduction in HDV RNA and disruption of the interaction between HDV RNA and the hepatitis delta antigen (HDAg) with a single dose of REP 2139. |
| 2023-05-01 | Replicor Inc. | Results Replicor updates clinical data on NAPs in three oral presentations at the 2023 Global Hepatitis Summit replicor.com ↗
In the REP 301 study, functional cure of HDV (undetectable HDV RNA with normal liver function) and functional and partial cure of HBV were preserved. |
| 2022-10-12 | Replicor Inc. | Results Replicor discloses anti-inflammatory properties of REP 2139 replicor.com ↗ |
| 2020-11-18 | Replicor Inc. | Results Replicor publishes its REP 301-LTF study achieving durable functional cure of HDV and HBV, inactivation of cccDNA and elimination of integrated HBV DNA replicor.com ↗
Importantly, the persistence of undetectable HDV RNA, normal liver function with improving fibrosis status continues for 3.5 years after removal of all therapy. |
| 2020-11-02 | Replicor Inc. | Results Replicor announces four presentations at AASLD including NAP target identification and well tolerated efficacy in cirrhotic infection replicor.com ↗
In collaboration with Abbott Diagnostics, analysis of HBsAg isoforms in the REP 301 and REP 401 studies providing evidence for the selective targeting of SVP by REP 2139 in humans (Poster 0819). |
| 2020-07-24 | Replicor Inc. | Results Replicor publishes follow-on study expanding its mechanistic understanding of REP 2139 replicor.com ↗
The specific inhibition of the assembly / secretion of HBV subviral particles with little to no impact on secretion of HBeAg or Dane particles. |
| 2020-05-12 | Replicor Inc. | Results Replicor announces publication of modelling study demonstrating potent activity of NAPs against HBV and HDV infection replicor.com ↗
The study established a model accurately predicting antiviral responses observed during REP 2139 modelling which included highly efficient inhibition of both HBsAg (98.2%) and HDV (99.7%). |
| 2020-03-09 | Replicor Inc. | Results Replicor announces publication of the REP 401 study achieving high rates of virologic control and functional cure in patients with chronic hepatitis B infection replicor.com ↗
Importantly 78% of participants achieved virologic control of HBV of whom 39% further achieved functional cure. |
| 2019-07-29 | Replicor Inc. | Results Replicor announces publication of new study examining HBsAg evolution during REP 2139 replicor.com ↗
From this deep sequencing analysis, no HBsAg quasispecies with mutations that would evade detection were observed throughout REP 2139 exposure. |
| 2019-02-18 | Replicor Inc. | Results Replicor announces publication of new study examining antiviral mechanisms of REP 2139 replicor.com ↗
This new data firmly establishes not only the ability of REP 2139 to block the release of HBsAg but also its ability to reduce intracellular HBsAg. |
| 2019-02-11 | Replicor Inc. | Results Replicor to update analysis of high rates of functional cure of HBV at APASL 2019 replicor.com ↗
demonstrating further treatment is no longer required in 85% of patients completing therapy |
| 2018-11-21 | Replicor Inc. | Results Replicor announces publication of new study validating HBsAg responses driven by REP 2139 replicor.com ↗
In the current study, HBsAg strains which cannot be detected by the industry standard HBsAg test platforms used in Replicor’s clinical studies were not observed at any time during REP 2139 exposure. |
| 2018-11-06 | Replicor Inc. | Results Replicor to disclose achievement of high rates of functional cure of HBV at AASLD 2018 replicor.com ↗
Replicor’s poster presentation (Poster 393), to be presented on Friday, November 9, 2018, will showcase the on-going follow-up analysis after removal of all treatment (now beyond 24 weeks in most patients) indicating normalization of liver function |
| 2018-10-15 | Replicor Inc. | Results Replicor showcases HBV functional cure data with REP 2139-Mg replicor.com ↗
In the latest REP 401 study, 48 weeks of triple combination therapy with tenofovir disoproxil fumarate, pegylated interferon and REP 2139-Mg has currently allowed 85% of patients to achieve this goal |
| 2018-06-18 | Replicor Inc. | Results Replicor demonstrates high rates of persistent functional control of HBV infection following cessation of all therapy replicor.com ↗
Liver function is normal in 92% of these patients. |
| 2018-06-11 | Replicor Inc. | Results Replicor updates mechanistic and clinical data demonstrating high rates of functional control of HBV and HDV infection at The Science of HBV Cure 2018 replicor.com ↗
REP 2139’s antiviral effects against HBV infection include not only blocking the assembly and release of subviral particles but reductions in intracellular HBsAg which are accompanied by inhibition of viral replication in the liver early during treatment in pre-clinical studies. |
| 2018-04-13 | Replicor Inc. | Results Replicor discloses long term functional control of HBV and HDV infection in high proportions of treated patients at EASL 2018 replicor.com ↗
In REP 401 patients completing treatment and at least 12 weeks of follow-up, functional control of HBV infection (HBV DNA < 1000 IU/mL or HBV DNA< LLOQ) currently persists in 25/33 patients (75%). |
| 2017-12-20 | Replicor Inc. | Results Replicor announces publication of its latest pre-clinical hepatitis B study: replicor.com ↗
REP 2139 and TDF/ETV combine synergistically to establish control of cccDNA in the liver |
| 2017-12-12 | Replicor Inc. | Results Replicor announces publication of its in vitro study on NAP activity in HDV replicor.com ↗
displayed no entry inhibitory activity against HDV and negligible interaction with HDV or HBV virions. |
| 2017-10-23 | Replicor Inc. | Results Replicor discloses the persistence of functional control off-therapy in 80% of patients with chronic hepatitis B from the REP 401 study at AASLD 2017 replicor.com ↗
This functional control is persisting in all patients (80%) after removal of all therapy with data available for 24 weeks in 4 patients, 12 weeks in 3 patients and 4 weeks in 1 patient. |
| 2017-10-10 | Replicor Inc. | Results Replicor to disclose late-breaking follow-up data from its REP 401 study at AASLD 2017 replicor.com ↗
control of HBV infection (HBsAg, anti-HBs and HBV DNA) and normalization of liver function is currently persisting for up to 24 weeks after withdrawal of all therapy |
| 2017-09-28 | Replicor Inc. | Results Replicor announces publication of its REP 301 study in HBV / HDV co-infection in The Lancet Gastroenterology & Hepatology replicor.com ↗
The critical importance of HBsAg reduction below 1IU/mL was emphasized by the lack of potentiation of pegIFN in three patients who achieved HBsAg levels as low as 16.4, 5.74 and 1.88 IU/mL during exposure to pegIFN. |
| 2017-06-28 | Replicor Inc. | Results Replicor announces publication of its studies on the antiviral activity of NAPs in recognized in vitro models of HBV infection replicor.com ↗
These studies demonstrated that early generation NAPs like REP 2055 had an ability to block viral entry only at high concentrations (5-10μM) while later generation (RNA) NAPs like REP 2139 and REP 2165 had negligible entry effect. |
| 2017-04-20 | Replicor Inc. | Results Replicor discloses achievement of 1 year functional control of HBV and HDV with NAPs and new mechanistic insights in NAP pharmacology replicor.com ↗
Deep sequencing of HBsAg in the previous REP 102 study showed no selection pressure with REP 2139, further validating the serum HBsAg response to NAP therapy (Poster THU-155). |
| 2017-02-20 | Replicor Inc. | Results Replicor discloses high rates of HBsAg loss with NAP combination therapy at APASL 2017 replicor.com ↗
In patients receiving NAPs in combination with TDF and peg-IFN, 8/9 patients receiving REP 2139 have experienced HBsAg reductions > 4 logs with HBsAg loss (HBsAg ≤ 0.01 IU / ml) in 7 of these patients. |
| 2016-11-15 | Replicor Inc. | Results Replicor discloses late breaking HBV and follow-up HBV / HDV clinical data at AASLD 2016 replicor.com ↗
Patients receiving REP 2139 or REP 2139 in addition to peg-IFN and TDF experienced robust, multilog reductions in HBsAg, increased levels of circulating anti-HBsAg antibodies and serum transaminase flares indicating restored immune response in the liver. |
| 2016-06-07 | Replicor Inc. | Results Replicor announces publication of its REP 101 and REP 102 studies demonstrating the therapeutic effect of NAPs and the achievement of functional control off treatment in human patients with chronic hepatitis B infection. replicor.com ↗
In both studies, NAP monotherapy was accompanied by 2 – 7 log reductions of serum HBsAg, 3 – 9 log reductions in serum HBV DNA, seroconversion of HBeAg and the appearance of serum anti-HBsAg antibodies. |
| 2015-06-30 | Replicor Inc. | Results Replicor discloses updated clinical trial data to the Global Virus Hepatitis Summit in Berlin replicor.com ↗ |
| 2015-06-10 | Replicor Inc. | Results Replicor to Present at the Israel Association for the Study of Liver Conference and the Global Virus Hepatitis Summit in Berlin in June replicor.com ↗
The data from the previous three clinical trials, together with the preliminary data from the REP 301 trial, demonstrate that REP 2139 used alone or in combination with Pegasys® or ZADAXIN® or Pegasys® and ETV is safe and well-tolerated. |
| 2013-04-26 | Replicor Inc. | Results Replicor presents updated clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139-ca and new clinical data in patients receiving this combination treatment while currently on entecavir (triple combination therapy). replicor.com ↗
All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. |
| 2013-02-27 | Replicor Inc. | Results Replicor updates clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. |
| 2012-11-12 | Replicor Inc. | Results Replicor updates clinical results demonstrating the achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. |
| 2012-09-25 | Replicor Inc. | Results Replicor discloses achievement of therapeutic vaccine-like responses in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139 replicor.com ↗
Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. |
| 2012-06-22 | Replicor Inc. | Results Replicor to disclose interim REP 2055 / 2139 clinical efficacy data in patients with chronic hepatitis B at the 14th International Symposium of Viral Hepatitis and Liver Disease (ISVHLD 2012) replicor.com ↗
Replicor will present updated clinical efficacy results and metadata analysis of antiviral responses in patients receiving REP 2055 or REP 2139 in an oral presentation on Sunday June 24th, 2012. |
All press releases naming this drug 52 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REP 2139 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02565719 ↗ |
| Known as | REP 2139-Ca | “the NAP REP 9AC' (REP 2139, given as a calcium chelate complex [REP 2139-Ca])” NCT02726789 ↗ |
| Known as | REP 2139-Mg | “REP 2139-Mg = magnesium chelate complex of REP 2139” NCT02565719 ↗ |
| Known as | REP 9AC' | “REP 9AC' (REP 2139) is a modified version of its predecessor, REP 9AC (REP 2055).” NCT02646189 ↗1“the NAP REP 9AC' (REP 2139, given as a calcium chelate complex [REP 2139-Ca])” NCT02726789 ↗ |
| Action | Inhibit | “Nucleic acid polymers (NAPs; REP 2139-Ca and REP 2139-Mg) are new antiviral drugs that block the assembly of subviral particles” PMID 31323705 ↗ Aug 2019 |
| Modality | Oligonucleotide (other) | “Nucleic acid polymers (NAPs; REP 2139-Ca and REP 2139-Mg)” PMID 31323705 ↗ Aug 2019 |
| Route | Intravenous | “REP 2139-Ca is administered weekly at 250 or 500mg doses by slow IV infusion.” NCT02646189 ↗ |