Drugs / REP 2165
last change Nov 2020 re-read 9 days ago

REP 2165

also known as REP 2165-Mg
Developed for
chronic hepatitis B virus infection
Investigated by
Replicor Inc.

Trials 1

201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02565719 Mar 2016 → May 2019 chronic hepatitis B virus infection Replicor Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 9

DateIssuerRelease
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 ↗
Well tolerated compassionate use of TDF and REP 2165-Mg in a cirrhotic individual with HBV / HDV coinfection, achieving simultaneous clearance of HDV RNA and HBsAg and HBsAg seroconversion (Poster 0827).
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.
2019-06-10 Replicor Inc. Results Replicor presents final REP 401 data demonstrating persistent functional cure of HBV replicor.com ↗
Moreover, 40% of participants further maintained functional cure, indicating the successful restoration of strong immunological control of their chronic HBV infection in the absence of therapy.
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
2018-11-06 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
2018-06-18 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.
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
2017-06-28 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.
2017-02-20 Replicor Inc. Results Replicor discloses high rates of HBsAg loss with NAP combination therapy at APASL 2017 replicor.com ↗
With REP 2165, a REP 2139 variant with improved tissue clearance, 6/10 patients have > 4 log reductions in HBsAg with loss occurring in 5 of these patients.

All press releases naming this drug 10 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as REP 2165 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02565719 ↗
Known as REP 2165-Mg “REP 2165-Mg = magnesium chelate complex of REP 2165” NCT02565719 ↗