Phase 1b Clinical Studies Ongoing in Patients with Chronic HBV Infection
DOYLESTOWN, Pa., Nov. 10, 2014
/PRNewswire/ -- Novira Therapeutics, Inc., a privately held
biopharmaceutical company developing novel therapies for curative
treatment of chronic hepatitis B virus (HBV) infection, today announced
the presentation of Phase 1a safety and pharmacokinetic data for its
lead HBV antiviral candidate, NVR 3-778 (also known as NVR-1221), in a
late-breaking poster presentation at the 2014 annual meeting of the
American Association for the Study of Liver Diseases in Boston. Dr. Edward J. Gane, Chief Hepatologist and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital in Auckland, New Zealand is the lead author on the poster and the principal clinical investigator for the study.
The
randomized, placebo-controlled Phase 1a trial enrolled 40 healthy adult
volunteers to assess the safety and tolerability of NVR 3-778 after
single oral doses of 50 to 800 mg/day, followed by an assessment of 200
mg once-daily dosing for 14 days. The study results indicated that NVR
3-778 was well-tolerated at all doses. There was no pattern of
treatment-related or dose-related clinical adverse events (AEs), and no
serious or severe AEs. All AEs were of common types, and most were not
attributed to study drug treatment. The AEs were all transient and mild
(grade 1) in severity except for two grade 2 AEs not attributed to study
treatment (sprain and tooth pain). The pharmacokinetic profile of NVR
3-778 indicated substantial dose-related plasma levels that were
consistent across the subjects within each dosing cohort. At doses of
200 mg or more, plasma concentrations of NVR 3-778 remained above in vitro HBV-inhibitory concentrations for more than 24 hours, supporting evaluation of once-daily dosing in HBV patients.
"These
encouraging Phase 1a results indicate that NVR 3-778 was well-tolerated
at all dose levels in human volunteers, and once-daily doses of 200 mg
or more provided systemic levels of NVR 3-778 high enough to potentially
be associated with antiviral efficacy in hepatitis B patients," said Nathaniel Brown
MD, Novira's Chief Medical Officer. "The Phase 1a results support
advancement to Phase 1b testing in patients with chronic HBV infection,
which is now underway. The Phase 1b clinical study is designed to
evaluate the safety and antiviral efficacy of NVR 3-778 in HBV patients
as both a single agent and in combination with current HBV therapies
after a four week dosing period."
About NVR 3-778
NVR
3-778 is a small molecule, direct acting antiviral, for oral
administration in patients with Chronic Hepatitis B (CHB) that inhibits
the HBV core or capsid protein. HBV core is a novel and promising drug
target with multiple activities required for viral replication and
persistence. Inhibition of HBV core protein function by NVR 3-778 offers
the potential for more efficient suppression of the virus leading to
improved durable viral suppression and functional cure rates.
About Novira Therapeutics
Novira
Therapeutics, Inc., is a privately held biopharmaceutical company
focused on discovery and development of first-in-class antiviral drugs
for the treatment of chronic HBV infection (CHB), a global disease with a
high level of unmet medical need. The company is employing innovative
chemistry and biology technologies to discover small molecule inhibitors
of the HBV core or capsid protein as well as other drugs with novel
mode of action. The company's novel antivirals will offer the potential
to address the limitations of current CHB therapies when used either as
mono-therapy or in combination with existing standards of care.
SOURCE Novira Therapeutics, Inc.
Read complete press release hereLabels: AASLD 2014, Novira clinical trial, NVR 3-778, NVR-1221