Drugs / REP 2139-Ca
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT02233075 | Sep 2014 → Nov 2016 | chronic hepatitis B virus infection | Replicor Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the final results of the long term follow-up of its REP 301 study (REP 301-LTF study) in Hepatology Communications. |
| 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%). |
| 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. |
| 2018-04-13 | 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 patients with HBV/HDV co-infection completing treatment (with only a 15 week overlap of REP 2139-Ca and pegIFN) and 1.5-2 years of follow-up, functional control of HDV infection (HDV RNA target not detectable) currently persists in 7/11 patients (64%). |
| 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. |
| 2016-02-16 | Replicor Inc. | Results Replicor to present pre-clinical and updated clinical data on REP 2139-Ca based combination therapy in chronic HBV and HBV / HDV co-infection at APASL 2016 replicor.com ↗
An update on the clinical response data from HBV /HDV co-infected patients completing REP 2139-Ca / peg-interferon combination therapy and transitioning to peg-interferon monotherapy in the REP 301 protocol will be presented in an oral presentation on Feb 22 nd (O-130). |
| 2015-12-01 | Replicor Inc. | Results Replicor to present pre-clinical and clinical data on REP 2139-Ca based combination therapy in chronic HBV / HDV co-infection at HEPDART 2015 replicor.com ↗
HDV RNA is now currently undetectable in ten patients (~5-8 log reduction from baseline). |
| 2015-11-16 | Replicor Inc. | Results Replicor discloses continued improvement of the antiviral response in patients with HBV / HDV co-infection receiving REP 2139-Ca based combination therapy replicor.com ↗
HDV RNA continued to decline in all patients and is now currently undetectable in ten patients (~5-8 log reduction from baseline). |
| 2015-10-15 | Replicor Inc. | Results Replicor presents updated mechanistic data and pre-clinical interferon-free combination treatment data in HBV and HBV / HDV co-infection replicor.com ↗
Improving the speed of on-treatment antiviral response to REP 2139-Ca with the addition of tenofovir disoproxil fumarate or entecavir in the absence of immunotherapy. |
| 2015-06-30 | Replicor Inc. | Results Replicor discloses updated clinical trial data to the Global Virus Hepatitis Summit in Berlin replicor.com ↗
These data demonstrate the continued elimination of serum HDV RNA during combination treatment in all patients. |
| 2015-04-29 | Replicor Inc. | Results Significant reduction of HBsAg and HDV RNA by REP 2139-Ca in Caucasian patients with HBV / HDV co-infection replicor.com ↗
Interim data, primarily from the REP 2139-Ca monotherapy phase of the trial, has demonstrated that REP 2139-Ca was well tolerated and resulted in the rapid and simultaneous multi-log reduction of both serum HBsAg and HDV RNA. |
| 2015-04-10 | Replicor Inc. | Results Replicor to Present at the 2015 Lancet Viral Hepatitis Conference replicor.com ↗
These clinical trials indicated that REP 2139-Ca appears to significantly increase the 12-month SVR rate achieved compared to existing therapies. |
| 2014-10-07 | Replicor Inc. | Results Replicor to present updated clinical trial data with combination treatment using its HBsAg-release inhibitors in patients with chronic hepatitis B infection at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society. replicor.com ↗
Data presented by Replicor during its presentation at the OTS meeting on Oct 15th will demonstrate 1) the unique ability of Replicor’s NAP compounds to completely suppress HBsAg in the blood 2) the effect of HBsAg clearance on dramatically improving the activity of immunotherapy and 3) when used with a full course of Pegasys™, NAP therapy has resulted in the establishment of long term SVR in 80% of patients. |
| 2013-05-14 | Replicor Inc. | Results Replicor presents clinical efficacy and toxicology results in patients with chronic hepatitis B with short term exposure to immunotherapy after REP 2139-ca induced clearance of serum HBsAg. replicor.com ↗
Both REP 2055 and REP 2139-ca were shown to rapidly and effectively remove HBsAg from the blood of patients with HBV infection. |
| 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 ↗
Patients who had cleared HBsAg from their blood with REP 2139-ca monotherapy were subjected to combination treatment with REP 2139-ca and either Pegasys™ or Zadaxin™. |
| 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. |
All press releases naming this drug 18 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | REP 2139-Ca | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02233075 ↗ |