AV5080 / AllaChem, Viriom, ChemDiv - LARVOL DELTA

Antiviral Susceptibility of Influenza A(H5N1) Clade 2.3.2.1c and 2.3.4.4b Viruses from Humans, 2023-2024. (PubMed, Emerg Infect Dis) - "In the neuraminidase inhibition assay, all viruses displayed susceptibility to neuraminidase inhibitor antiviral drugs oseltamivir, zanamivir, peramivir, laninamivir, and AV5080...All viruses were susceptible to polymerase inhibitors baloxavir and tivoxavir and to polymerase basic 2 inhibitor pimodivir with 50% effective concentrations in low nanomolar ranges. Because drug-resistant viruses can emerge spontaneously or by reassortment, close monitoring of antiviral susceptibility of H5N1 viruses collected from animals and humans by using sequence-based analysis supplemented with phenotypic testing is essential."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Resistance profiles for the investigational neuraminidase inhibitor AV5080 in influenza a and B viruses. (PubMed, Antiviral Res) - "The resistance profiles and predicted binding modes of AV5080 and zanamivir are most similar, but dissimilar to those of oseltamivir, in part because of a guanidine moiety compensatory binding effect. Overall, our data suggests that AV5080 is a promising oral-dosed NAI that exhibited similar or superior in vitro efficacy against viruses with reduced or highly reduced inhibition phenotypes with respect to currently approved NAIs."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Antiviral susceptibility of clade 2.3.4.4b highly pathogenic avian influenza A(H5N1) viruses isolated from birds and mammals in the United States, 2022. (PubMed, Antiviral Res) - "Of 1015 sequences of HPAI A (H5N1) viruses collected in the United States during 2022, eight viruses (∼0.8%) had a molecular marker of drug resistance to an FDA-approved antiviral: three adamantane-resistant (M2-V27A), four oseltamivir-resistant (NA-H275Y), and one baloxavir-resistant (PA-I38T)...Oseltamivir was least potent at inhibiting NA activity, while the investigational NA inhibitor AV5080 was most potent, including against NA mutants...Viruses with PA-I38M or PA-A37T showed 5- to 10-fold reduced susceptibilities. As HPAI A (H5N1) viruses continue to circulate and evolve, close monitoring of drug susceptibility is needed for risk assessment and to inform decisions regarding antiviral stockpiling."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Study Evaluating the Efficacy and Safety of AV5080 in Patients With Uncomplicated Influenza (clinicaltrials.gov) - P3; N=700; Not yet recruiting; Sponsor: Viriom

Clinical • New P3 trial • Infectious Disease • Respiratory Diseases

Dose Range Study to Evaluate the Efficacy and Safety of AV5080 in Patients With Influenza (clinicaltrials.gov) - P2; N=135; Completed; Sponsor: Viriom

Clinical • New P2 trial • Infectious Disease • Respiratory Diseases

Viriom donates Elpida to Chinese and Russian governments for experimental use against COVID-19; also working with global health authorities to determine the efficacy and safety of Elpida and its other clinical candidates AV5080, AV5124 and AV5126 against Covid-19 (PRNewswire) - "Viriom Inc today announces...experimental use of the HIV medicine, Elpida (elsulfavirine) and Viriom's experimental flu medicines AV5080, AV5124 and AV5126 to determine their efficacy in the treatment of COVID-19....The company is collaborating with Chinese Center for Disease Control and Prevention and the Ministry of Health in Russia and select health authorities and institutions in US and globally....Viriom is collaborating with PLA Military Academy and Zhejiang University in China, ChemRar Group, Gamaleya Research Institute of Epidemiology and Microbiology, Research Center Institute of Immunology in Russia, Osang Healthcare in South Korea to support research of targeted medicines with novel mechanisms of action against COVID-19 and other pathogenic RNA viruses."

Licensing / partnership