DOYLESTOWN, Pa., June 8, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to advance treatments that can provide a bridge to a cure for chronic hepatitis B virus (HBV), today announced the acceptance of oral presentations highlighting ATI-2173, Antios' lead therapeutic HBV candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and ATI-1428 and ATI-1645, candidates from Antios' 4th generation capsid assembly modulators (CAM) program. These presentations will be given at the European Association for the Study of the Liver's International Liver Congress 2022 (EASL ILC 2022), taking place June 22 – 26, 2022 at the ExCeL London Exhibition Centre in London, UK.

Antios will be presenting the 90-day, Phase 2a study of ATI-2173 in combination with tenofovir disoproxil fumarate (TDF). This double-blind, randomized, placebo-controlled study of 20 adult patients was designed to assess the efficacy and safety of 25 and 50 mg doses of ATI-2173 daily for 90 days in combination with TDF compared with TDF plus placebo (control) in chronic HBV-infected subjects. The primary endpoints included the percentage of patients experiencing adverse reactions and time to HBV viral load relapse. In addition to adverse reactions, as a part of the primary safety endpoint, the safety evaluations recorded off-treatment ALT flares in all treatment groups.

Antios will also present preclinical data from ATI-1428 and ATI-1645, which are in investigational new drug enabling development. These candidates are class II CAMs with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted and beneficial antiviral response by the immune system. To date, data in a transgenic mouse model for both compounds provide initial evidence for potent in vitro and in vivo activity, an excellent pharmacokinetic profile, and no accumulation of empty capsids in the hepatocellular cytoplasm.

"We see ATI-2173 as a bridge to a cure – an important first step in the ultimate search for a cure for HBV," said Greg Mayes, Chief Executive Officer of Antios. "To date, the data have been encouraging, indicating that combining ATI-2173 with a nucleoside analogue such as TDF in a simple, once-a-day regimen has the potential to completely shut down HBV polymerase activity and viral replication. We look forward to presenting our Phase 2a data, as well as the initial data from our CAM program, at the upcoming International Liver Congress."

Title: Sustained 12-week off treatment antiviral efficacy of ATI-2173, a novel active site polymerase inhibitor nucleotide, combined with tenofovir disoproxil fumarate in chronic hepatitis B patients, a phase 2a clinical trial (#296)

•  Author/Presenter: Douglas Mayers, M.D.
•  Presentation Type: Oral Presentation
•  Date/Time: June 25, 2022, at 9:15am BST

Title: Novel ultra-potent capsid assembly modulators prevent abnormal accumulation of empty capsids and associated T-cell mediated liver injury in a mouse model of hepatitis B virus infection (#291)

•  Author/Presenter: Luca Guidotti, M.D., Ph.D.
•  Presentation Type: Oral Presentation
•  Date/Time: June 25, 2022, at 5:30pm BST

ATI-2173, Antios Therapeutics' lead once-daily, oral drug candidate for treating HBV, is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 has the potential, if approved, to be a bridge to a potential cure for HBV. It is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development, and its mechanism of action is designed to be complementary to other approaches that also seek to achieve a functional cure.

ATI-1428 and ATI-1645 are 4th generation, class II capsid assembly modulators (CAMs), both with a novel and unique ultra-potent mechanism of action design that may provide for a more targeted, productive antiviral response by the immune system. Derived from a novel chemical scaffold, these CAMs have shown strong in vitro and in vivo activity in a transgenic mouse model of HBV infection. As CAMs with an ultrapotent design inducing no accumulation of empty capsids based on an initial preclinical mouse study, ATI-1428 and ATI-1645 represent promising candidates for clinical development and have entered investigational new drug enabling development. ATI-1428 and ATI-1645 were acquired by Antios in November of 2021 from San Raffaele Hospital (OSR), Istituto Nazionale Genetica Molecolare (INGM), and IRBM/Promidis, a collaboration of Italian research institutes and a global contract research organization.

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection, which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that up to 300 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately two million people in the United States suffer from chronic HBV infection. Approximately 900,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Its lead drug candidate ATI-2173 – the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) for HBV in clinical development – has the potential, if approved, to become a potential bridge to a cure for chronic HBV. Antios is also developing a novel series of 4th generation capsid assembly modulators (CAMs) to further expand Antios' portfolio of differentiated molecules in the HBV space. HBV is a major unmet global health problem affecting up to 300 million people worldwide, more than hepatitis C and HIV combined. For more information, please visit www.antiostherapeutics.com.

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