Develop safer drugs without unexpected toxicity

Frontier AI systems to predict, explain, and fix human toxicity risks better than animal testing.

Toxicity is a leading cause of clinical trial failures

Every year, unexpected toxicity denies patients many effective medicines and costs industry billions of dollars.

SOURCE GLP-1 pill for obesity discontinued due to liver toxicity April 14, 2025SOURCE Oral obesity drug dropped after seeing liver safety concern June 26, 2023SOURCE Phase II trials for Alzheimer’s terminated drug due to liver toxicity October 26, 2023SOURCE 2 deaths put gene therapy's liver safety in the spotlight once again August 12, 2022SOURCE FDA rejects would-be blockbuster over toxicity concerns August 19, 2022SOURCE Lead asset dropped over bilirubin side effects February 18, 2025

SOURCE Unfortunate and unexpected' clinical hold after liver failure in atopic dermatitis trial February 20, 2024SOURCE Stock Crashes 21% After A Surprise Side Effect Hammered Its Drug December 9, 2024SOURCE Latest victim of raised liver enzymes, shutters trial and sees shares slide December 15, 2022SOURCE FDA places warning on NK3 antagonist because it could cause liver damage September 12, 2024SOURCE Early Cancer Trial Stopped Over Liver Toxicity, Drops Out of Race May 23, 2024SOURCE BTK inhibitor again slows MS progression, but liver enzymes continue to be tricky September 20, 2024

SOURCE PTH1R agonist dropped over bilirubin side effects 4 months after going public February 18, 2025SOURCE Another Alzheimer's failure after BACE drug sparks liver safety fears June 13, 2013SOURCE Serious liver injury being observed in patients without cirrhosis taking treatment for biliary cholangitis December 12, 2024SOURCE ATR inhibitor promise for advanced solid tumors dimmed by liver toxicity April 10, 2024SOURCE In analysis of gene therapy deaths, points to underlying liver issue November 16, 2023SOURCE Stops Program Following Clinical Hold Due to Single SAE of Severe Liver Injury November 11, 2024

SOURCE Stock plummets after FDA raises safety concerns November 3, 2016SOURCE More anguish as safety signal sinks midphase kidney disease trial June 30, 2022SOURCE Strigle to escape toxicity labyrinth as safety signal sinks cancer program and share price July 13, 2023SOURCE Target candidate canned over off-target toxicity August 11, 2022SOURCE GI toxicity hits midstage GLP-1 drug as patients drop out April 27, 2018SOURCE Five Deaths in Prostate Cancer Trial Send Stock Plummeting May 10, 2024

SOURCE Out of KRAS race as toxicity sees ditched phase 1 effort July 30, 2022SOURCE Gene therapy trial halted after patient suffers serious toxicity November 12, 2019SOURCE FDA halts trial of ADC over 'significant risk of illness June 17, 2024SOURCE Halted sleep disorder med trial over 'visual disturbances' and CV effects November 29, 2023SOURCE Halted enrollment of lead trial after grade 3 side effects April 02, 2024SOURCE Paused phase 2 lung fibrosis trial on advice of safety committee February 10, 2025

SOURCE FDA Puts Clinical Hold on Drug Due to Preclinical Safety Signals April 15, 2024SOURCE Biopharma stock Crashes 21% After A Surprise Side Effect Hammered Its 'Very Safe' Drug December 9, 2024SOURCE Axed late-phase DMD drug over safety signal, FDA talks November 07, 2024SOURCE Shift in focus after FDA places hold on experimental Alzheimer’s drug January 26, 2026SOURCE FDA restricts use of drug due to liver injury risk May 27, 2021SOURCE Weight-loss meds get liver-injury warning May 27, 2010

SOURCE FDA officials worried over Ketek July 18, 2006SOURCE FDA withdraws approval of ADHD drug October 24, 2005SOURCE CGRP receptor antagonist meets Phase III migraine end points November 11, 2009SOURCE Discontinued Phase 3 Study of BTK inhibitor in Myasthenia Gravis February 7, 2023SOURCE Elevated liver enzymes force Centessa to drop a 2nd asset in 2 months August 10, 2022

Old Paradigm

40% - 50% of drugs fail because of toxicity.

90% of drugs fail clinical trials; clinical toxicity is a leading cause despite preclinical lab and animal toxicity experiments ¹ SOURCE Impact of a five-dimensional framework on R&D productivity at AstraZeneca Nature Reviews Drug Discovery ² SOURCE An analysis of the attrition of drug candidates from four major pharmaceutical companies Nature Reviews Drug Discovery ³ SOURCE Costs of Drug Development and Research and Development Intensity in the US, 2000-2018 JAMA Network Ope
Tens of billions of dollars are lost to late stage drug toxicity

Old Paradigm

Existing physical experiments are inaccurate and expensive.

Animal testing has poor predictive performance for human liver injury ⁴ SOURCE Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database Toxicology and Applied Pharmacology
Lab experiments show good specificity but lack sensitivity ⁵ SOURCE Setting Clinical Exposure Levels of Concern for Drug-Induced Liver Injury (DILI) Using Mechanistic in vitro Assays Toxicological Sciences ⁶ SOURCE Utility of spherical human liver microtissues for prediction of clinical drug-induced liver injury Archives of Toxicology
Experiments costs thousands to millions of dollars and take weeks to months to run

Changing Industry

Current experimental methods are becoming obsolete.

Congress dropped the legal requirement for animal testing⁷ SOURCE “The FDA no longer requires all drugs to be tested on animals before human trials” Science | AAAS
Congress and the FDA have announced they are phasing out animal experiments⁸ SOURCE "FDA Announces Plan to Phase Out Animal Testing Requirement" FDA Commissioner
Industry, big pharma, regulators, and academia are looking for alternative approaches

New Paradigm

It's time to accurately predict toxicity in humans.

AI that accurately assesses risk of a drug's toxicity in humans from the earliest stages of drug discovery and development
AI that explains reasons and mechanisms behind toxicity risk and drug exposure rather than just raising an alert