Assembly Biosciences completes enrolment in two Phase IIa HBV trials

8th January 2019 (Last Updated January 8th, 2019 09:47)

Assembly Biosciences has completed patient enrolment in two ongoing Phase IIa trials evaluating ABI-H0731 for the treatment of chronic hepatitis B virus (HBV).

Assembly Biosciences completes enrolment in two Phase IIa HBV trials
Hepatitis B virus under electron microscope. Credit: Sanofi Pasteur via Flickr.

Assembly Biosciences has completed patient enrolment in two ongoing Phase IIa trials evaluating ABI-H0731 for the treatment of chronic hepatitis B virus (HBV).

Interim data from both the ABI-H0731-201 and ABI-H0731-202 studies are expected to be available during the second quarter of this year.

Assembly Biosciences president and CEO Derek Small said: “The data from these studies will serve to inform the timelines of the HBV cure programme as well as the design of future registrational studies.

“We anticipate sharing interim data from the ongoing studies at scientific conferences this year.”

"The data from these studies will serve to inform the timelines of the HBV cure programme."

ABI-H0731-201 is a viral antigen proof-of-concept trial that included HBeAg positive and negative patients whose viral load has exceeded on the active nucleos(t)ide (NUC) therapy.

Patients will continue to receive their NUC therapy and will be randomised in 3:2 ratio to be treated with either placebo or ABI-H0731 for a period of six months.

The trial aims to assess the effectiveness of ABI-H0731 in inhibiting the generation of new covalently closed circular DNA (cccDNA).

It also intends to investigate the de novo combination of ABI-H0731 and NUC therapy (entecavir) to NUC monotherapy alone.

ABI-H0731-202 is a ‘viral load’ that hired treatment-naïve HBeAg positive patients.

Once the six-month study period ends, patients will get an opportunity to rollover to an open-label combination (ABI-H0731 plus NUC) phase to receive treatment for up to one additional year.

Findings from the trial are anticipated to help create timelines and registration strategies for potent core inhibitor ABI-H0731.