Novira completes Phase 1a clinical study of NVR-1221 for treatment of HBV infection

Sep 4 2014

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."