Model Medicines presented an update on its lead candidate MDL-001 at the Biocom Global Partnering Conference in California, positioning the asset as a first-in-class oral direct-acting antiviral with demonstrated preclinical activity across various viral families, including respiratory, hepatic, and gastrointestinal viruses. With such a broad therapeutic spectrum, MDL-001 has potential to address unmet needs including pandemic preparedness across multiple infectious diseases, says GlobalData, a leading intelligence and productivity platform.
MDL-001 targets the Thumb-1 domain of viral ribonucleic acid (RNA)-dependent RNA polymerases (RdRp), a structurally conserved site across multiple RNA virus families. The drug candidate has demonstrated in vitro efficacy across respiratory viruses (respiratory syncytial virus (RSV), SARS-CoV-2, and influenza), hepatic viruses (hepatitis C virus (HCV), hepatitis B virus (HBV), and hepatitis D virus (HDV), and gastrointestinal viruses (norovirus).
Model Medicines has also reported that MDL-001 demonstrated preclinical equivalence to Gilead’s remdesivir in SARS-CoV-2 animal models and to Gilead’s sofosbuvir in HCV models. It also reported superiority to Pfizer’s nirmatrelvir based on comparative analyses of antiviral activity against SARS-CoV-2 in preclinical models.
Abigail Harris, Infectious Disease Analyst at GlobalData, comments: “Direct-acting antivirals have transformed outcomes in HCV, with most patients now able to achieve a functional cure. However, greater unmet needs remain in HBV, and particularly HDV, an infection that only occurs in those already infected with HBV.”
HBV therapy currently remains largely suppressive rather than curative and often requires long-term administration, although several functional cure components are currently in late-stage development. Additionally, HDV infection continues to be associated with poorer liver-related outcomes and limited approved treatment options.
According to GlobalData’s Pipeline Products Database, there are several early-stage pipeline products—aside from MDL-001—that are in development for both HBV and HCV infections, including UBI Pharma’s UB-551 and Bolder Biotechnology’s BBT-012, both in preclinical development. However, many investigational approaches continue to explore interferon-based or immune-modulating strategies.
Harris continues: “Model Medicine’s single oral direct-acting antiviral demonstrating activity across HCV, HBV, and HDV, including co-infection models, represents a differentiated approach, particularly in terms of addressing unmet needs for patients infected with more than one hepatic virus.”
Beyond hepatic infections, MDL-001’s reported activity against respiratory viruses such as RSV, SARS-CoV-2, and influenza may carry strategic implications. In respiratory settings, broad-spectrum antiviral activity could support early empiric treatment when the specific viral pathogen has not yet been confirmed, or in cases where patients are co-infected with more than one virus. Such versatility may offer advantages during seasonal surges or outbreak scenarios, where rapid therapeutic deployment is critical.
Harris concludes: “Broad-spectrum antiviral development has long been a goal in infectious disease research and development (R&D), particularly in the context of pandemic preparedness and chronic viral burden. A single oral agent demonstrating activity across multiple viral families could also be viewed favorably in government stockpiling strategies, where therapeutic flexibility and rapid deployability are key considerations. While MDL-001 remains in preclinical development, its breadth of reported activity positions it as a programme to watch as it advances toward IND submission and clinical evaluation.”
