Company's compound accepted into National Institute of Health's (NIH) Antiviral Program for Pandemics based upon submission of a significant data package including preclinical data demonstrating protection against the primary symptomatic endpoint of COVID-19 and reduction in the viral load of SARS CoV-2 in lungs, as well as clinical human safety and tolerability data, in vivo efficacy data, and preclinical pharmacokinetics data.
LA JOLLA, Calif. – Model Medicines, the pharmatech company working to transform the drug discovery and development industry and accelerate the creation of life-changing drugs using artificial intelligence (AI) and machine learning (ML), today announced preclinical results demonstrating once daily, oral dosing of MDL-001 significantly reduces the viral load of SARS-CoV-2 (the virus that causes COVID-19) in the lungs of an established mouse-adapted animal model of SARS-CoV-2 infection (two-way ANOVA, P < 0.01). The company previously reported data demonstrating that once daily, oral dosing of MDL-001 protected against the primary symptomatic endpoint (weight-loss) of COVID-19 (two-way ANOVA, P < 0.05). In combination, these results place MDL-001 in an exclusive group of drug candidates that have been reported to demonstrate both significant relief of the symptoms of COVID-19 and significant reduction of viral load in the lungs. These data are the subject of a manuscript being developed in collaboration with previously announced research partners, Arnab Chatterjee, PhD, at California Institute for Biomedical Research (Calibr), Scripps Research, as well as Adolfo Garcia-Sastre, PhD, and Kris White, PhD, at the Global Health and Emerging Pathogens Institute, Icahn Mount Sinai School of Medicine.
Today, on the strength of these promising preclinical results, Model Medicines also announced that the company has signed a Non-Clinical Evaluation Agreement (NCEA) with the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Disease (NIAID) and National Institutes of Health (NIH) as part of the Antiviral Program for Pandemics (APP). The Antiviral Program for Pandemics was created "to develop safe and effective antivirals to combat SARS-CoV-2..., as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential". Inclusion in APP is limited to "the most promising antiviral candidates" and unlocks significant NIH resources for Model Medicines and MDL-001 including "preclinical services to ensure antiviral candidates advance quickly to evaluation in human participants" and support of Phase 1 clinical trials.
Despite a significant global effort, the global community continues to search for a potent, orally available, direct-acting antiviral with an extended half-life and a safety and tolerability profile that enables dosing to all patient groups regardless of SARS-CoV-2 variant, age, gender, comorbidities or level of disease. Many monoclonal antibodies, like REGENCOV, do not work for certain variants. Other commercially available agents, like Veklury, must be given via IV and have not shown viral load reductions in outpatient settings. Drugs that are given orally, such as Paxlovid and Lagevrio, have reported issues with both drug-drug interactions and genotoxicity, respectively. Model Medicines discovered and developed MDL-001, a potent, orally available, direct-acting antiviral agent with an extended half-life, which makes it conducive for simplified patient dosing. The drug has previously been evaluated in Phase I clinical studies evaluating safety and tolerability in a separate indication, and no concerns were noted. Together, these characteristics make MDL-001 an attractive candidate for the next generation of COVID-19 therapies.
Davey Smith, MD, Chief of Infectious Diseases and Global Public Health at UCSD commented, "We are very pleased with the demonstrated potent antiviral activity of MDL-001. Such potent activity may lead to faster recovery time for patients with COVID-19 while minimizing the transmission of infection. As COVID-19 continues to evolve worldwide, we need a multi-pronged approach to control this disease. MDL-001, a potent, oral, safe and well tolerated, direct-acting agent may offer a convenient treatment to prevent disease progression and allow people to resume daily life more quickly, especially in areas where vaccines and antibody therapies are not readily available."
"The combination of the safety and tolerability profile, mode of administration and potency of MDL-001 continues to provide us with confidence that it has both the profile to be used in hospital and outpatient settings and the profile for treatment of mild, moderate and severe disease for all patient groups regardless of SARS-CoV-2 variant, age, gender or comorbidities, which should significantly alleviate the burden on healthcare systems," said Daniel Haders Ph.D, CEO at Model Medicines. "As we continue to advance our antiviral program, we look forward to sharing further results and analysis, including reporting detailed preclinical efficacy and pharmacokinetic results."
ABOUT THE MDL-001 DEVELOPMENT PROGRAM
MDL-001 is an oral, direct-acting antiviral agent that is currently undergoing IND (Investigational New Drug) enabling preclinical evaluation as a treatment for patients with COVID-19 in collaboration with partners including Calibr Scripps Research, the Global Health and Emerging Pathogens Institute, Icahn Mount Sinai School of Medicine and the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Disease (NIAID) and National Institutes of Health (NIH) as part of the Antiviral Program for Pandemics (APP). Model Medicine intends to submit a pre-IND briefing package to the FDA (Food and Drug Administration) for review in the coming weeks.
