DOYLESTOWN, Pa., May 8, 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 that it initiated a Phase 1a clinical study of NVR-1221. The
Phase 1a clinical study is designed to assess the pharmacokinetic
profile and dose-related safety and tolerability of NVR-1221 in healthy
"We are thrilled to begin the clinical development NVR-1221," said Lalo
Flores, Ph.D., the co-Founder, President and Chief Scientific Officer at
Novira. "NVR-1221 belongs to a new class of antiviral agents that
target the viral core or capsid protein of the hepatitis B virus.
Achievement of this important milestone positions NVR-1221 to be the
first agent to test the curative potential of HBV core inhibitors in the
The Phase 1a clinical study follows successful completion of the
Clinical Trial Application (CTA) regulatory process in New Zealand. The
clinical study will investigate the dose-related safety/tolerance and
pharmacokinetics (PK) of NVR-1221 in approximately 40 healthy
volunteers. Upon completion and satisfactory outcome of the Phase 1a
clinical study, Novira will commence a Phase 1b clinical study to test
the safety, PK and initial antiviral activity of NVR-1221 in patients
with chronic HBV infection.
"The initiation of this Phase 1a clinical study marks an important
milestone for Novira as it moves closer to bringing innovative and
potentially curative approaches to patients with chronic HBV infection,"
said Christian S. Schade, Chief Executive Officer at Novira. "We look
forward to completing this Phase 1a trial over the coming months and
commencing a Phase 1b clinical study to test NVR-1221 in chronic HBV
patients as mono-therapy and in combination with approved agents."
NVR-1221 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-1221 offers
the potential for a more efficient suppression of the virus leading to
improved durable viral suppression and cure rates.
Hepatitis B infection presents a significant unmet medical need with an
estimated 350 million people worldwide living with chronic HBV
infection. A significant number of patients with chronic infection incur
a higher risk of developing cirrhosis and cancer. It is estimated that
60% of hepatocellular carcinoma (liver cancer) is a direct consequence
of HBV infection. Current drugs approved for the management of CHB
include PEG-Interferon and nucleot(s)ides which can effectively suppress
virus replication, but rarely lead to a cure.
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.
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Labels: Novira clinical trial, NVR-1221