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Replicor update

Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, today announced that an updated interim analysis from its latest REP 401 clinical trial has been selected by the Asia Pacific Association for the Study of Liver (APASL) for oral presentation at its annual meeting to be held February 15-19, 2017 in Shanghai, China.

The REP 401 protocol (NCT02565719) is a randomized, controlled trial assessing the safety and efficacy of its first in class HBsAg release inhibitor, REP 2139 and a REP 2139 derivative with improved plasma and tissue clearance (REP 2165) in combination with tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha-2a (peg-IFN) in treatment naïve patients with chronic HBeAg negative HBV infection.
The updated clinical analysis, to be presented on Feb 18th (OP 116) will include substantially longer exposure analysis in experimental and control groups and include for the first initial analysis of antiviral response when NAP therapy is added 24 weeks after peg-IFN therapy in crossover patients in the adaptive comparator control arm.
Replicor’s presentation from APASL 2017 will be available on the company’s website following its disclosure at the meeting at www.replicor.com/science/conference-presentations. For further information about the 2017 APASL Meeting visit: http://www.apasl2017.org/#/.
3 Responses
Avatar universal
APASL2017:
OP116
Update on safety and efficacy in the REP 401 protocol: REP
2139-Mg or REP 2165-Mg used in combination with tenofovir
disoproxil fumarate and pegylated interferon alpha 2A
in treatment naı¨ve caucasian patients with chronic HBeAg
negative HBV infection
Michel Bazinet1, Victor Pantea2, Gheorghe Placinta2, Iurie
Moscalu3, Valentin Cebotarescu2, Lilia Cojuhari2, Pavlina
Jimbei4, Liviu Iarovoi2, Valentina Smesnoi4, Tatiana Musteata4,
Alina Jucov2,3, Adalbert Krawczyk5, Andrew Vaillant1
1Replicor Inc., Montre´al, Canada; 2Department of Infectious
Diseases, Nicolae, Testemitanu State University of Medicine and
Pharmacy, Testemitanu, Moldova; 3ARENSIA Exploratory Medicine,
Republican Clinical Hospital, Testemitanu, Moldova; 4Toma Ciorbaˇ
Infectious Clinical Hospital, Bucharest, Romania;
5Universita¨tsklinikum Essen, Institute for Virology, Essen, Germany
Background: The nucleic acid polymer REP 2139 clears serum
HBsAg in chronic HBV infection, improving the efficacy of
immunotherapy and facilitating establishment of functional control
off treatment. The REP 401 protocol (NCT02565719) is a randomized,
controlled trial assessing the safety and efficacy of REP 2139
and a REP 2139 derivative with improved clearance (REP 2165) in
combination with tenofovir disoproxil fumarate (TDF) and pegylated
interferon alpha 2a (peg-IFN) in treatment naı¨ve patients with chronic
HBeAg negative HBV infection.
Methods: Forty patients will receive 26 weeks of lead-in TDF
(300 mg PO qD) followed by randomization (1:1) into experimental
and control groups. The experimental group will receive 48 weeks of
TDF (300 mg PO qD), peg-IFN (180 lg SC qW) and REP 2139-Mg
or REP 2165-Mg (1:1, 250 mg IV infusion qW). Patients in the
control group will receive 48 weeks of TDF + peg-IFN but will
crossover to 48 weeks of experimental therapy in the absence of a 3
log drop in HBsAg after 24 weeks of peg-IFN. Serum viremia is
being monitored offsite at the Institute for Virology, Universita
¨tsklinikum Essen, Essen, Germany.
Result: Twenty-nine patients have received C12 weeks of treatment
in control and experimental groups. After TDF lead-in, most patients
have serum HBV DNA B10 IU/ml prior to peg-INF exposure. Triple
combination therapy is well tolerated in all patients. One patient
receiving REP 2165-Mg developed infusion reactions after the 20th
dose, otherwise no infusion reactions have been observed with either
NAP. Serum HBsAg reductions, increases in serum anti-HBs or
serum ALT/AST/GGT flares were negligible or absent during the
TDF lead-in and in all but 2 patients in the control groups to date. In
patients having completed 12 weeks of NAP exposure, 9/9 receiving
REP 2139-Mg and 6/9 patients receiving REP 2165-Mg have experienced[
1 log reductions in serum HBsAg. HBsAg reductions are[3
log in 7/9 REP 2139 patients and 4/9 REP 2165 patients. Increases in
serum anti-HBs are the most dramatic in these patients. NAP-mediated
HBsAg reductions are accompanied by otherwise asymptomatic
ALT/AST/GGT flares substantially greater than those in the control
group.
Conclusion: These updated preliminary data continue to confirm the
tolerability and efficacy of REP 2139 and REP 2165 when used in
combination with peg-IFN and TDF in patients with HBeAg negative
chronic HBV infection. Early clearance in serum HBsAg mediated by
NAPs is correlated with the onset of an intense transaminase flare and
suggests NAP-mediated HBsAg clearance improves the efficacy of
peg-IFN in this patient population.
Hepatol Int (2017) 11 (Suppl 1):S1–S1093 S85
4 Comments
This sounds close to the aasld 2016 report and has most likely not included the further status improvements that one is expecting in the combo treated patients. It looks like we will have to wait until the February 18 presentation details will be available on the replicor website. Since November 2016 the combo had substantial time to show its effects and the results will be quite revealing to see if the impressive data in the hbv/hdv coinfected group can be repeated in the e antigen negative mono infected group
studyforhope, do you know when we can expect some follow-up results for people who finished treatment with decent number of antibodies ? So it may prove that it's not just temporary effect. I guess hbv/hdv trial started first so people from that trial are not on any treatment now ?
At the 2016 aasld meeting, most hdv/hbv combo patients were getting close to the end of treatment. Of these almost 50% still had a very high antibody level.

By now the true follow up is in progress and I hope we can also see some of these follow up data at the upcoming APASL and EASL meetings.
found that presentation: Despite the suboptimal combination regimen used, 5/12
patients maintained HBsAg loss and 7/12 patients
maintained undetectable HDV RNA 24 weeks after
treatment withdrawal.

I hope other naps in combo with nucs and peginf will get even better results :)
Avatar universal
We cross our fingers for favourable results.
2 Comments
Its selected for presentation, so i am expecting this one may go good.
Is this is final phase or some more rails are there?
At this time, our hope is mostly vested on Replicor as various companies have abandoned their trials, like the birinapant and arrowhead, etc. I ggues replicor's trials are currently in phase 2, and their results are in general promising resulting in reduction of hbsag, a protein which is reponsible for the persistence of the hbv infection.
Avatar universal
It's February 18, was the presentation released?
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