ATI-2173 / Antios Therap - LARVOL DELTA

Active site polymerase inhibitor nucleotides (ASPINs): Potential agents for chronic HBV cure regimens. (PubMed, Antivir Chem Chemother) - "Although currently available nucleos(t)ide analogues (eg, tenofovir disoproxil fumarate, tenofovir alafenamide, entecavir) effectively control HBV replication, they are seldom curative (functional cure rate ∼10%) and require lifelong treatment for most patients. Thus, ATI-2173 is currently in clinical development as an agent for HBV cure. Here, we review the mechanism of action and preclinical and clinical profiles of clevudine and ATI-2173 to support the role of ASPINs as part of curative regimens for chronic HBV infection."

Journal • Review • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Myositis

Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects (clinicaltrials.gov) - P1 | N=37 | Terminated | Sponsor: Antios Therapeutics, Inc | Active, not recruiting ➔ Terminated | Trial primary completion date: May 2022 ➔ Aug 2022; Terminated by the Sponsor

Trial primary completion date • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection (clinicaltrials.gov) - P2a | N=40 | Terminated | Sponsor: Antios Therapeutics, Inc | Active, not recruiting ➔ Terminated; Terminated by the Sponsor

Combination therapy • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Randomized Phase 1b Trial of the Active Site Polymerase Inhibitor Nucleotide ATI-2173 in Patients With Chronic Hepatitis B Virus Infection. (PubMed, J Viral Hepat) - P1 | "In this 28-day monotherapy study, ATI-2173 demonstrated safety and antiviral activity, with sustained off-treatment effects and substantially reduced systemic clevudine exposure. These results support evaluation of ATI-2173 with tenofovir disoproxil fumarate in phase 2 studies."

Clinical • Journal • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

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 (EASL-ILC 2022) - P2a | "Background and aims: ATI-2173 is a novel phosphoramidate livertargeted prodrug of clevudine that functions as an active site polymerase inhibitor nucleotide (ASPIN). Similar on- and off-treatment HBV DNA antiviral activity was observed between 25 mg and 50 mg cohorts of ATI-2173 + TDF. In the off-treatment period, ATI-2173 + TDF provided prolonged HBV DNA suppression, longer time to rebound, and absence of ALT flares compared toTDFalone. 24-week off-treatment data will be presented at the conference."

Clinical • P2a data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Non-alcoholic Fatty Liver Disease

A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2a | N=2 | Terminated | Sponsor: Antios Therapeutics, Inc | N=10 ➔ 2 | Trial completion date: Feb 2023 ➔ May 2022 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2023 ➔ May 2022; Sponsor stopped due to partner collaboration ending

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2a | N=10 | Recruiting | Sponsor: Antios Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: Antios Therapeutics, Inc | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection (clinicaltrials.gov) - P2a | N=40 | Active, not recruiting | Sponsor: Antios Therapeutics, Inc | Trial primary completion date: Apr 2022 ➔ Jul 2022

Combination therapy • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Antios Therapeutics, Inc

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Antios Therapeutics, Inc | Recruiting ➔ Completed

Trial completion

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection (clinicaltrials.gov) - P2a | N=40 | Active, not recruiting | Sponsor: Antios Therapeutics, Inc | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2a | N=10 | Not yet recruiting | Sponsor: Antios Therapeutics, Inc

Combination therapy • New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Antios Therapeutics, Inc | Recruiting ➔ Completed

Trial completion

Assembly Biosciences Outlines Anticipated 2022 Pipeline Development Milestones (GlobeNewswire) - "Assembly Biosciences, Inc...today outlined anticipated progress and milestones for its development pipeline in 2022....1H 2022...Complete enrollment for the two ongoing triple combination studies with VBR + NrtI and AB-729, Arbutus Biopharma’s RNAi therapeutic candidate, and with VBR + NrtI + PEG-IFNα. Initiate triple combination cohort with VBR + NrtI and ATI-2173, Antios Therapeutics’ investigational active site polymerase inhibitor nucleotide (ASPIN). Initiate Phase 1b study of ABI-H3733 in patients with chronic HBV infection...2H 2022...Report initial on-treatment data from triple combination cohort with VBR + NrtI and ATI-2173; Report initial Phase 1b data for ABI-H3733."

Clinical data • Enrollment status • New P1 trial • P1 data • Trial status • Hepatitis B • Infectious Disease

Antios Therapeutics and Arbutus Biopharma Announce First Patient Dosed in Phase 2a Combination Trial of ATI-2173, AB-729 and Tenofovir Disoproxil Fumarate in Patients with Chronic Hepatitis B Virus Infection (GlobeNewswire) - "Antios Therapeutics, Inc...and Arbutus Biopharma Corporation...announced that the first patient has been dosed in a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 (Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple combination of Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nucleotide reverse transcriptase inhibitor."

Trial status • Hepatitis B • Infectious Disease

Antios Therapeutics Announces Presentations on ATI-2173 at Hep DART 2021 Meeting (PRNewswire) - "Antios Therapeutics, Inc...announced two oral presentations will be presented at the Hep DART 2021 meeting being held December 5-9, 2021, in Cabo San Lucas, Mexico...Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies."

Preclinical • Hepatitis B • Infectious Disease

A Phase 1 Drug-Drug Interaction Study Between ATI-2173 and Midazolam or Clarithromycin in Healthy Subjects (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Antios Therapeutics, Inc

Clinical • New P1 trial

A Phase 1 Drug-Drug Interaction Study Between ATI-2173 and Tenofovir Disoproxil Fumarate in Healthy Subjects (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Antios Therapeutics, Inc

Clinical • New P1 trial

A Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection (clinicaltrials.gov) - P2a; N=40; Recruiting; Sponsor: Antios Therapeutics, Inc; N=30 ➔ 40; Trial completion date: Jun 2022 ➔ Oct 2022; Trial primary completion date: Dec 2021 ➔ Apr 2022

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV (PRNewswire) - "Antios Therapeutics, Inc...announced the successful closing of a $75 million Series B-1 financing. The financing round was co-led by GordonMD Global Investments...The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios' lead Phase 2b clinical candidate."

Financing • Hepatitis B • Infectious Disease

Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients with Chronic Hepatitis B Virus Infection (PRNewswire) - "Antios Therapeutics, Inc. and Assembly Biosciences, Inc...announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios' investigational proprietary active site polymerase inhibitor nucleotide (ASPIN), vebicorvir (VBR), Assembly Bio's investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor...This cohort is expected to start in the first half of 2022 and will enroll 10 treatment naïve or off-treatment HBeAg negative or positive patients in a 12-week treatment study."

Enrollment status • Licensing / partnership • Hepatitis B • Infectious Disease

Antios Therapeutics Announces Presentation at ICE-HBV Toronto Annual Symposium in Conjunction with the International HBV Meeting (PRNewswire) - "Antios Therapeutics, Inc...announced that Douglas Mayers, M.D., Chief Medical Officer and Co-Founder of Antios, will be giving a presentation on ATI-2173, an investigational liver-targeting Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development as a critical component of a combination regimen to potentially provide a functional cure for chronic hepatitis B (HBV) infection. The presentation will take place at the International Coalition to Eliminate HBV (ICE-HBV) Toronto Annual Symposium in conjunction with the International HBV Meeting on September 30, 2021."

Clinical data • Hepatitis B • Infectious Disease

A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P1; N=88; Completed; Sponsor: Antios Therapeutics, Inc; Active, not recruiting ➔ Completed; Trial completion date: Sep 2021 ➔ May 2021

Clinical • Trial completion • Trial completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Arbutus Biopharma and Antios Therapeutics Announce Clinical Collaboration Agreement to Evaluate AB-729 in Combination with ATI-2173 in Subjects with Chronic Hepatitis B Virus Infection (GlobeNewswire) - "Antios Therapeutics, Inc. and Arbutus Biopharma Corporation...announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus’ proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios’ proprietary active site polymerase inhibitor nucleotide (ASPIN), ATI-2173, and Viread (tenofovir disoproxil fumarate), for the treatment of subjects with chronic hepatitis B virus (HBV) infection. ATI-2173, AB-729 and Viread will be evaluated in combination in a single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial...This cohort is expected to initiate in the second half of 2021."

Licensing / partnership • Trial status • Hepatitis B • Infectious Disease