Company CHEMprint™ technology platform and drug discovery expertise responsible for one of the world’s first AI-discovered drugs to reach this stage of development.
LA JOLLA, Calif., May 17, 2022 /PRNewswire/ — Model Medicines, the pharmaceutical company working to transform the drug discovery and development industry using artificial intelligence (AI) and machine learning (ML), announced today submission of a pre-IND briefing document and meeting request to the Food and Drug Administration (FDA) and receipt of an granted meeting request 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. Antiviral activity of MDL-001 was discovered by CHEMprint from Model MedicinesMT AI drug discovery platform and developed in collaboration with world-renowned researchers from 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 primary indication in SARS-CoV-2/COVID-19.
MDL-001 has now demonstrated a best-in-class combination of potential antiviral characteristics. First, in a mouse disease model adapted to SARS-CoV-2 at the Icahn School of Medicine of the Mount Sinai Institute for Global Health and Emerging Pathogens led by Adolfo García-Sastre, PhD and Kris WhitePhD, MDL-001 demonstrated a log reduction in SARS-CoV-2 viral loadten 2.7 PFU/mL at 375 mg/kg twice daily on day 3 post infection. By way of comparison, Owen et al, in a November 2, 2021 Science article, reported that PF-07321332 (Nirmatrelvir) demonstrated a logten 1.91CCID50/mL reduction in viral load at 1000 mg/kg BID on day 4, in a separate SARS-CoV-2-adapted mouse disease model. Second, MDL-001 demonstrated a statistically significant reduction in preclinical COVID-19 symptoms at the first observable time point in the model. Third, in vitro studies at Mount Sinai found that MDL-001 inhibited SARS-CoV-2 variants of concern (VoCs) with nanomolar-level activity in a cell-based assay for disease. Fourth, MDL-001 has also been shown to inhibit the H1N1 influenza virus in cell assays. Details of these findings will be reported in an upcoming peer-reviewed manuscript led by Kris WhitePhD (Mount Sinai) with co-authors including Adolfo García-Sastre, PhD (Mount Sinai), Arnab ChatterjeePhD (Scripps Research), David SmithMD (UCSD) and the Model Medicines team.
“MDL-001 demonstrated a rare combination of in vitro nanomolar activity on VoCs, preclinical symptom reduction at the model detection limit, preclinical viral load reduction greater than 2.5 logs, antiviral activity at spectrum and clinical safety and tolerability, making it an exciting new generation of oral SARS-CoV-2 and pan-antiviral therapeutic candidate,” said Kris WhitePhD, senior author of the manuscript and assistant professor of microbiology at the Icahn School of Medicine at Mount Sinai.
“As an infectious disease physician who treats patients with various respiratory infections caused by RNA viruses, such as influenza and SARS-CoV-2, I know that physicians need safe and effective antiviral therapies with broader activity than is currently available.These respiratory viral infections often appear the same clinically and it takes crucial time to get test results and choose the right antiviral for the infection.Like how we have antibiotics that treat many types of bacterial infections, the next generation of antivirals should also have broader activity, allowing effective therapy to begin as soon as possible. MDL-001 has the potential to fill this therapeutic void and create a New Treatment Paradigm for Viral Respiratory Diseases,” David SmithMD, head of infectious diseases and global public health at UCSD added.
Based on the preclinical data reported above, Model Medicines submitted a pre-IND meeting request and a comprehensive pre-IND briefing document to the FDA’s Division of Antiviral Products (AVD). Sean Russellco-founder and vice president of model drug regulation, said, “We are excited to advance MDL-001; a potentially best-in-class oral antiviral drug for COVID-19, based on evidence from non-clinical concept and IND activation. Upcoming comments from the FDA will provide us with essential information to define our parallel development pathways for Model Medicines programs in COVID-19 and other viral indications.”
“We launched Model Medicines with the goal of creating a first technology pharmaceutical company that would disrupt pharmacoeconomic models of drug development and create the best medicines that save lives or modify disease at an unprecedented rate. a pre-IND briefing The 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 therapeutics using AI and have brought to this stage of development with unprecedented efficiency and leading the market in terms of capital and time thanks to the dedication of our multidisciplinary team of chemists, biologists, computer and data scientists, clinicians and proven drug hunters. of class and many other drugs discovered by our AI platform at the clinic in suc quick surrender,” remarked Daniel J. Haders IIPhD, co-founder and CEO of Model Medicines.
ABOUT THE MDL-001 DEVELOPMENT PROGRAM
MDL-001 is a direct-acting oral antiviral agent that is currently undergoing an IND (Investigational New Drug) allowing preclinical evaluation as a treatment for patients with COVID-19 in collaboration with partners such as 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) of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH) under the Pandemic Antiviral Program (APP). Model Medicine has submitted a pre-IND backgrounder and meeting request dataset to the Food and Drug Administration (FDA) for MDL-001. This request for a pre-IND meeting was granted.
ABOUT MODEL DRUGS
Model Medicines is an Artificial Intelligence and Machine Learning Drug Discovery company that reduces the time to market of a drug by more than 10 years and the cost of bringing a drug to market by more than 1 billion dollars. Model Medicines is transforming drug discovery by leveraging historical drug development data compendium, an independent drug and disease discovery platform, and unbiased AI to create Phase II/III-ready drug candidates in months rather than a few years. The company has developed a strong portfolio of patent-pending therapeutic products for oncology, infectious diseases, gastric disorders, neurological disorders and weight disorders. The company is based in La Jolla, California. www.modelmedicines.com
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