Model Medicines Announces AI-Discovered Oral Antiviral Therapeutic, MDL-001, Has Demonstrated Potential Best-In-Class Combination Of Viral Load Reduction, Symptom Reduction, Activity Against SARS-CoV-2 Variants And Pan Antiviral Activity

Company's CHEMprint^™ technology platform and drug hunting expertise responsible for one of the world's first AI-discovered drugs to achieve this stage of development.

La Jolla, CA /PRNewswire/ - Model Medicines, the pharmatech company working to transform the drug discovery and development industry using artificial intelligence (AI) and machine learning (ML), today announced submission of a Pre-IND Briefing Document and Meeting Request to the FDA (Food and Drug Administration) and receipt of a Meeting Request Granted letter for MDL-001. This places the company in an exclusive group of AI-drug discovery companies known to have discovered a small molecule therapeutic using AI and brought it to this stage of development. MDL-001's antiviral activity was discovered by Model Medicines' CHEMprint^TM AI-drug discovery platform and developed in collaboration with world-renowned researchers at Scripps Research and the Icahn School of Medicine at Mount Sinai. The drug is being developed as a therapeutic with broad antiviral activity with a lead indication in SARS-CoV-2/COVID-19.

MDL-001 has now demonstrated a combination of potential best-in-class antiviral characteristics. First, in a SARS-CoV-2 adapted mouse model of disease at the Icahn School of Medicine at Mount Sinai's Global Health and Emerging Pathogens Institute led by Adolfo García-Sastre, PhD and Kris White, PhD, MDL-001 demonstrated SARS-CoV-2 viral load reduction of log₁₀ 2.7 PFU/mL at 375 mg/kg BID dosing on Day 3 post infection. For comparison, Owen et al, in a November 2, 2021 Science article, reported that PF-07321332 (Nirmatrelvir) demonstrated a log₁₀ 1.91 CCID₅₀/mL reduction in viral load at 1000 mg/kg BID on Day 4, in a separate SARS-CoV-2 adapted mouse model of disease. Second, MDL-001 demonstrated statistically significant reduction of preclinical symptoms of COVID-19 at the earliest time point observable in the model. Third, in vitro studies at Mount Sinai found that MDL-001 inhibited SARS-CoV-2 Variants of Concern (VoC's) with nanomolar level activity in a cell based assay of disease. Fourth, MDL-001 was found to inhibit the H1N1 Influenza virus in cell based assays as well. Details of these findings will be reported in an upcoming peer-reviewed manuscript led by Kris White, PhD (Mount Sinai) with co-authors, including Adolfo García-Sastre, PhD (Mount Sinai), Arnab Chatterjee, PhD (Scripps Research), Davey Smith, MD (UCSD) and the Model Medicines team.

"MDL-001 has demonstrated a rare combination of nanomolar in vitro activity across VoC's, preclinical symptomatic reduction at the limit of detection of the model, preclinical viral load reduction greater than 2.5 logs, broad-spectrum antiviral activity and clinical safety and tolerability, which make it an exciting next generation oral SARS-CoV-2 and pan-antiviral therapeutic candidate," said Kris White, PhD, lead author of the manuscript and Assistant Professor of Microbiology at the Icahn School of Medicine at Mount Sinai.

"As an infectious disease doctor who treats patients with various respiratory infections from RNA viruses, like influenza and SARS-CoV-2, I know physicians need safe and effective antiviral therapies with broader activity than what is currently available. These respiratory viral infections often look the same clinically and it takes crucial time to obtain test results and choose the right antiviral for the infection. Like how we have antibiotics that treat many types of bacterial infections, so too should the next generation of antivirals have broader activity, allowing effective therapy to be started as quickly as possible. MDL-001 has the potential to fill this therapeutic void and create a new treatment paradigm for respiratory viral illnesses," Davey Smith, MD, Chief of Infectious Diseases and Global Public Health at UCSD added.

Based on the preclinical data reported above, Model Medicines has submitted a Pre-IND Meeting Request and complete Pre-IND Briefing Document to the FDA's Division of Antiviral Products (DAV). Sean Russell, Co-Founder and Vice President of Regulatory for Model Medicines commented, "We are pleased to advance MDL-001; a potential best-in-class oral antiviral medication for COVID-19, through nonclinical proof-of-concept and IND-enabling studies. Forthcoming feedback from the FDA will provide us with critical information relevant to defining our parallel development paths for Model Medicines' programs in both COVID-19 and other viral indications".

"We launched Model Medicines with the goal of building a technology first pharmaceutical company that would upend pharmacoeconomic models of drug development and create best-in-class life saving or disease-altering drugs at an unprecedented pace. Model's submission of a Pre-IND Briefing Document and Meeting Request to the FDA for MDL-001 places the company in an exclusive group of AI-drug discovery companies, known to have discovered a small molecule therapeutic using AI and brought it to this stage of development. The company has accomplished this feat with unprecedented, market leading efficiency in terms of both capital and time thanks to the dedication of our multidisciplinary team of chemists, biologists, computer and data scientists, clinicians and proven drug hunters. We look forward to bringing MDL-001, a potential best-in-class therapeutic, and numerous other drugs discovered by our AI platform to the clinic in rapid succession," remarked Daniel J. Haders II, PhD, Co-Founder and CEO of Model Medicines.

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 has submitted a Pre-IND Briefing Document and Meeting Request data package to the FDA (Food and Drug Administration) for MDL-001. This request for a pre-IND Meeting has been granted.

About Model Medicines
Model Medicines is an artificial intelligence and machine learning Drug Discovery company that reduces the time to bring a drug to market by 10+ years and the cost to bring a drug to market by $1B+. Model Medicines is transforming drug discovery by leveraging the historical compendium of drug development data, a drug and disease agnostic discovery platform, and unbiased AI to create Phase II/III ready drug candidates in months rather than years. The company has developed a robust pipeline of patent-pending therapeutics for oncology, infectious diseases, gastric disorders, neurological disorders, and weight disorders. The company is based in La Jolla, CA. www.modelmedicines.com