Viral disease biotech Antios Therapeutics shut down earlier this year after an FDA hold on its lead hepatitis B therapy due to a serious adverse event proved insurmountable.
First, the data: Antios reported on the midstage trial of ATI-2173 over the weekend at the European Association for the Study of the Liver's International Liver Congress 2022. The 90-day study combined ATI-2173 with tenofovir disoproxil fumarate, which is marketed by Gilead as Viread.
DOYLESTOWN, Pa., June 25, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing transformative treatments for hepatitis B virus (HBV), today announced new data from the Phase 2a clinical trial of ATI-2173, its lead investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. Antios also announced new data on its 4th generation capsid assembly modulator (CAM) program evaluating ATI-1428 and ATI-1645. In the 90-day Phase 2a trial, adult patients receiving ATI-2173 in combination with tenofovir disoproxil fumarate (TDF) showed slower virologic rebound than patients receiving TDF plus placebo after stopping treatment.
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 Therapeutics announced that ATI-2173, its investigational proprietary active site polymerase inhibitor nucleotide, has been placed on clinical hold by the U.S. FDA following submission of a safety report. The report involved a patient who received a triple combination therapy involving ATI-2173 in an ongoing hepatitis B trial who subsequently experienced bradycardia and hypotension. The FDA has requested an independent cardiology review. Due to this clinical hold, Assembly Biosciences has terminated the Clinical Trial Collaboration Agreement between the two companies.
Assembly disclosed the FDA clinical hold and the termination of the collaboration in a regulatory filing. Doylestown, Pennsylvania-based Antios, which is the party of record for the clinical trial, said Wednesday that it has observed no signs of safety problems associated with its drug, ATI-2173. Nevertheless, the FDA has asked for an independent cardiology assessment of the Antios molecule.
DOYLESTOWN, Pa., March 30, 2022 /PRNewswire/ -- Antios Therapeutics, Inc. (Antios), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced new data from the Phase 1b and 2a clinical trials of ATI-2173, its investigational proprietary drug candidate and the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development for HBV. These data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity. Data from these trials will be presented in two poster sessions during the 31st Conference of the Asian Pacific Association for the Study of Liver (APASL), taking place in Seoul, South Korea on March 30, 2022 – April 3, 2022.
MENDHAM, N.J. and WARMINSTER, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- nAntios Therapeutics, Inc. (“Antios”) and Arbutus Biopharma Corporation n(Nasdaq: ABUS) today announced that the first patient has been dosed in antriple combination treatment in patients with chronic hepatitis B virusn(HBV) infection. A single cohort in the ongoing Antios Phase 2a SAVE-1 n(Sustained Anti-Viral Efficacy) clinical trial will evaluate a triple ncombination of Antios’ proprietary active site polymerase inhibitor nnucleotide (ASPIN), ATI-2173, Arbutus’ proprietary GalNAc delivered RNAintherapeutic, AB-729, and tenofovir disoproxil fumarate (TDF), a nnucleotide reverse transcriptase inhibitor.