Model Medicines today announced that it has been selected for an oral presentation at ID Week 2025. Here, it will unveil the complete preclinical Proof-of-Concept data package for MDL‑001, its oral broad-spectrum antiviral clinical candidate. MDL‑001 is a non-nucleoside inhibitor of RNA-dependent RNA polymerase (RdRp) that demonstrates consistent multi-log reductions in viral load across multiple viral families in vivo.

• Preclinical Milestones: MDL-001 has demonstrated in vivo proof of concept (PoC) against three viral families and in vitro efficacy against seven, making it the most expansive oral broad-spectrum antiviral candidate to date.
• Advancing Toward Clinical Trials: Model Medicines is completing IND-enabling studies, has initiated a GMP manufacturing program, and is planning regulatory filings in 2026, with clinical trial initiation immediately following IND clearance. 
• New Era of Virology: MDL-001 is a first-in-category, non-nucleoside antiviral that challenges traditional virus-specific treatment approaches. The drug is part of Model Medicines’ virology program that has demonstrated broad antiviral activity, from viruses causing acute respiratory disease to viruses causing chronic liver diseases, as well as emerging viral threats.

New in vivo results build upon preliminary in vitro studies in corona, influenza and hepatitis viruses and demonstrate broad-spectrum therapeutic potential applicable to future outbreak response, stockpiling, and first-line monotherapy or combination therapy for seasonal and chronic viruses.  The data package reflects reproducible efficacy in preclinical models generated at multiple globally recognized research institutes, offering compelling support for the compound’s advancement into clinical trials.

"As a clinician, we need an antiviral that can be deployed the moment a patient presents. Like we do with antibiotics, we should have something ready to start before we know exactly what bug is causing the problem," said Davey Smith, MD, MAS, clinician and virologist at UCSD. "MDL‑001 is likely that, an antiviral with broad-spectrum activity that can be used as monotherapy or in combination with current standards of care at patient presentation. The data we are presenting at ID Week will, for the first time, publicly demonstrate its potential to reshape frontline clinical decision-making.”

“This is the definitive preclinical dataset we’ve been building toward,” said Daniel Haders II, Ph.D., Founder and CEO of Model Medicines. “Clear, reproducible, in vivo antiviral activity across diverse viral families, strong differentiation in mechanism, compelling pharmacokinetics and safety data and a direct path to clinical development. As we look ahead to regulatory filings in 2026 and human trials immediately following IND clearance, we’re confident MDL‑001 has the potential to reshape how broad-spectrum antivirals are designed and deployed.”

The presentation includes collaborations with researchers at the Icahn School of Medicine at Mount Sinai, UC San Diego, and Scripps Research, including virologists Dr. Adolfo García-Sastre, Dr. Kris White, Dr. Davey Smith, and Dr. Philippe Gallay, who were instrumental in the validation and characterization of MDL‑001’s antiviral activity across diverse viral families.

“Most antiviral drug development remains concentrated around a small set of viral targets, primarily proteases and nucleoside analogs,” said Dr. Philippe Gallay, Professor of Immunology at Scripps Research. “What differentiates MDL‑001 is the depth and breadth of the preclinical data. There has never been an orally available antiviral that has demonstrated multi-log viral load reductions across the breadth of viral families that MDL-001 inhibits. That’s what makes this dataset unprecedented, and what makes MDL‑001 a potential cornerstone of viral therapy.”

MDL‑001 has successfully achieved preclinical proof-of-concept in multiple viruses and is completing IND-enabling studies. Model Medicines has initiated a GMP manufacturing program and is planning regulatory filings in 2026, with clinical trial initiation immediately following IND clearance. MDL-001 is being advanced in multiple indications due to data that demonstrates the drug’s utility in multiple viral diseases.

Current Virology Standards of Care and Clinical Need for Broad-Spectrum Therapeutics

Current standards of care for major viral infections remain narrowly targeted, with most therapies developed for virus-specific indications and acting through a limited number of mechanisms. For respiratory viruses, treatment paradigms vary but remain reactive and indication-specific. COVID-19 management relies on Veklury® (remdesivir), Paxlovid® (nirmatrelvir/ritonavir), and Lagevrio® (molnupiravir). Influenza treatment options include neuraminidase inhibitors such as Tamiflu® (oseltamivir) and endonuclease inhibitors like Xofluza® (baloxavir marboxil). Respiratory syncytial virus (RSV) is typically managed through monoclonal antibody prophylaxis and select fusion inhibitors, though therapeutic options for active treatment remain limited. Chronic viral liver infections are similarly segmented. Hepatitis B virus (HBV) is managed using nucleos(t)ide analogs like Viread® (tenofovir disoproxil fumarate) and Baraclude® (entecavir), while hepatitis C virus (HCV) is treated with direct-acting antivirals such as Harvoni® (sofosbuvir/ledipasvir). For hepatitis D virus (HDV), therapeutic choices are minimal, primarily pegylated interferons, which have suboptimal efficacy and significant tolerability issues. Despite therapeutic success in isolated indications, these treatments do not address the broader threat landscape: co-infections, zoonotic spillover, rapid viral mutation, and limited coverage in outbreak response. A first-line, orally available, broad-spectrum antiviral that can be deployed at the point of care remains an unmet medical and strategic imperative.