About Hepatitis B
Attaining a functional cure for chronic hepatitis B virus (HBV) will likely require modulation of the immune system.
- Approximately 257 million people are chronically infected with the Hepatitis B virus (“HBV”), including approximately 17 million people in the United States and Europe.
- HBV leads to progressive liver disease and nearly 900,000 deaths each year.
- The current standard of care requires chronic treatment with antiviral therapies to suppress the HBV virus. Currently available treatments for HBV include direct-acting antivirals that suppress viral replication, Baraclude® (entecavir) and Viread® (tenofovir). In addition, in Europe, pegylated interferon-α, or PEG-IFN-α, products are indicated for first line treatment of HBV virus according to EASL guidelines for certain patient populations. However, direct-acting antivirals have a limited impact on clearing HBV surface antigen (HBsAg) while PEG-IFN-α has been associated with significant negative side effects.
- There remains an unmet need for antiviral and immunomodulatory therapies that are easily administered, have a favorable safety profile and can be used in combination as a functional cure for chronic HBV.
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About inarigivir soproxil
Inarigivir soproxil (inarigivir) is being developed as a simple, safe and selective oral immunomodulator for inclusion in a combinatorial treatment of the chronic hepatitis B virus with a goal to substantially increase functional cure rates.
Inarigivir, is an orally available candidate being developed for the treatment of chronic hepatitis B virus infection. We have designed inarigivir to be selectively active within cells infected with HBV. Inarigivir binds the cellular proteins retinoic acid-inducible gene 1 (RIG-I) and nucleotide-binding oligomerization domain-containing protein 2 (NOD2) to inhibit viral replication and to cause the induction of intracellular interferon signaling pathways for antiviral defense. We believe inarigivir has the potential to be part of a simple, safe and selective combinatorial treatment modality that elevates the functional cure rates for patients with chronic HBV.
We are currently conducting a Phase 2 multi-center clinical trial of inarigivir, which we refer to as the ACHIEVE trial. Part A of the ACHIEVE trial is a randomized, placebo-controlled, multiple ascending dose trial in up to 80 non-cirrhotic patients infected with chronic HBV using doses of 25 mg, 50 mg, 100 mg and 200 mg of inarigivir as an oral monotherapy administered daily for 12 weeks. Following this treatment, all patients will receive treatment with the oral antiviral agent tenofovir disoproxil fumarate (marketed by Gilead as Viread®) as a monotherapy for 12 weeks.
We initiated the ACHIEVE trial in June 2016 and we released results from the first three cohorts in May 2017, October 2017, November 2017 , April 2018, August 2, 2018
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Inarigivir Co-Administration with Tenofovir
Inarigivir will be studied in two separate fixed-dose combination studies with Gilead’s Viread® and Vemlidy®, with the goal of creating a combinatorial approach for an HBV functional cure. In Part B of the ACHIEVE Phase 2 trial, 100 mg inarigivir will be co-administered with Viread® for 12 weeks and compared to Viread® monotherapy. This trial is expected to begin in the second half of 2018. In a separate Phase 2 trial being conducted by Gilead, inarigivir will be co-administered with Vemlidy® and compared to Vemlidy® monotherapy. This trial began in the first quarter of 2018.