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News breaking: 2017-04-20

Replicor presenteert 1-jarige functionele beheersing HBV en HDV met NAP en nieuw mechanisch inzicht in farmacologie van NAP

MONTREAL-(BUSINESS WIRE)- Replicor Inc., een niet-beursgenoteerde farmaceut die mikt op een medicijn tegen chronische hepatitis b en hepatitis d, heeft vandaag significante nieuwe gegevens gepubliceerd over NAP-activiteit bij hepatitis b- en hepatitis d-infecties. Replicor presenteerde de data op de jaarlijkse bijeenkomst van de European Association for the Study of the Liver (EASL), die van 19 tot 23 april plaatsheeft in Amsterdam.

Updates van de onderzoeken REP 301 (naar co-infecties van hepatitis b en d) en REP 401 (naar hepatitis b) lieten aanzienlijke vooruitgang zien:

1. In REP 301 bleef de reeds eerder gerapporteerde functionele beheersing na 24 weken van hepatitis b (5/12 patienten) en hepatitis d (7/12 patienten) behouden na 1 jaar. Dit is bewijs voor de duurzaamheid van de functionele beheersing die NAP-gerichte therapie tot stand brengt (poster LBP-507).

2. In het onderzoek REP 401 zijn 30 patienten ten minste 12 weken blootsgesteld aan NAP en de HBsAg-respons van het serum blijft naar verloop van tijd verbeteren: de huidige daling ten opzichte van de nulmeting zijn >1log bij 29 patienten, >2logs bij 25 patienten, >4logs bij 19 patienten en HBsAg-verlies bij 14 patienten. De verbeterde effectiviteit van pefIFN (gemarkeerde anti-HBs-productie en/of therapeutische aanwakkering van transaminase) was waarneembaar bij alle patienten met een HBsAg-reductie van > 4 log (poster THU-154).

3. Verrassend genoeg wijst analyse van HBsAG, HBeAG, HBcrAg, RNA van het hepatitis-b-virus, DNA van het hepatitis-b-virus en RNA van het hepatitis-d-virus erop dat HBsAg bijna geheel afkomstig is van integratie.

Replicor discloses achievement of 1 year functional control of HBV and HDV with NAPs and new mechanistic insights in NAP pharmacology

MONTREAL-(BUSINESS WIRE)- Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic HBV and HDV infection, today disclosed significant new data on NAP activity in HBV and HDV infections at the European Association for the Study of the Liver (EASL) 2017 annual meeting held April 19-23, 2017 in Amsterdam, The Netherlands.

Updates in the REP 301 (HBV/HDV coinfection) and REP 401 (HBV infection) studies demonstrated important advances:

1. In the REP 301 study, previously reported functional control at 24 weeks follow-up of HBV (5/12 patients) and HDV (7/12 patients) was shown to be maintained at one year, demonstrating the durability of functional control established with NAP based therapy (poster LBP-507).

2. In the REP 401 study, 30 patients have received at least 12 weeks of NAP exposure and serum HBsAg response over time continues to improve: current reductions from baseline presented were >1log in 29 patients, >2logs in 25 patients, >4logs in 19 patients, with HBsAg loss in 14 patients. Improved efficacy of pegIFN (marked anti-HBs production and/or therapeutic transaminase flares) occurred in all patients with HBsAg reduction > 4 log (poster THU-154).

3. Surprisingly, analysis of serum HBsAg, HBeAg, HBcrAg, HBV RNA, HBV DNA and HDV RNA in both studies indicated that circulating HBsAg appears to be almost completely derived from integration.

"The notion that almost all circulating HBsAg is derived from integration has important therapeutic implications," said CSO Dr. Andrew Vaillant. "As the primary immunosuppressive agent in HBV and HDV infections, HBsAg removal will be critical. It's very likely that new investigational agents with other antiviral mechanisms will still require agents directly targeting HBsAg release like NAPs in order to achieve a high rate of functional control." Dr. Bazinet, CEO, added "our continually expanding clinical data continues to demonstrate that significant rates of functional control of HBV and HDV can be achieved with currently approved drugs and NAPs."

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). A recently developed tissue culture system now reproduces for the first time the post-entry effects of NAPs on secretion of HBV particles observed preclinically and clinically (Poster THU-156).

Dr. Vaillant remarked, "The ability to model the post-entry effects of NAPs in tissue culture is the culmination of more than 6 years of work which including various collaborators worldwide. With this tool finally in place, the host mechanisms targeted by NAPs can now begin to be explored."

Replicor's presentations from EASL 2017 are now available at www.replicor.com/science/conference-presentations. For the 2017 EASL Meeting: https://ilc-congress.eu/.

About Replicor

Replicor is a privately held biopharmaceutical company with the most advanced clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV infection. www.replicor.com

View source version on businesswire.com: http://www.businesswire.com/news/home/20170418006582/en/

Contacts

Natacha Dorget

ndorget@replicor.com

514-733-1998