Pharmacokinetics, Safety and Tolerability of NVR-1221 Support
Advancement to Phase 1b Clinical Studies in Patients with Chronic HBV
Infection
DOYLESTOWN, Pa., Sept. 4, 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 successful completion of a Phase
1a clinical study of NVR-1221. The results for the Phase 1a clinical
study demonstrated NVR-1221 was safe and well-tolerated at all doses in
40 healthy volunteers. The complete safety and pharmacokinetics (PK)
analysis of the Phase 1a data will be presented at an upcoming
scientific conference.
Novira also announced that it has commenced
enrollment of its Phase 1b clinical studies of NVR-1221. The Phase 1b
clinical studies are planned to test the safety, PK and initial
antiviral activity of NVR-1221 in patients with chronic HBV infection as
mono-therapy and in combination with approved therapy. The Phase 1b
clinical studies are expected to enroll up to 48 patients with chronic
HBV infection in the mono-therapy dose-ranging study, followed by up to
an additional 48 HBV patients in the combination clinical study of
NVR-1221 with approved therapy.
"We are very pleased with the results of the Phase
1a clinical study and look forward to advancing NVR-1221 into Phase 1b
clinical studies and patients with chronic HBV infection," said
Christian S. Schade, Novira's Chief Executive Officer. "Either as
mono-therapy or in combination with current standards of care, NVR-1221
represents a new class of small molecule to potentially offer HBV
patients the opportunity for sustained viral suppression leading to
higher functional cure rates."
About NVR-1221
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 more efficient suppression of the
virus leading to improved durable viral suppression and cure rates.
Read complete press release here: Labels: clinical trials, NVR-1221