In February 2022, Insilico Medicine announced yet another milestone – the Company had brought its novel AI-discovered and AI-designed IPF drug to Phase 1 trials in record time, advancing from start to Phase 1 in under 30 months
and for significantly less cost than traditional drug discovery.
Insilico's AI system, trained on disease and aging, had zeroed in on a compound that demonstrated highly promising results in multiple preclinical studies including in vitro biological studies, pharmacokinetic and safety studies. The compound also improved myofibroblast activation, a contributor to the development of fibrosis with a novel and was shown to have potential relevance in a broad range of fibrotic indications, not just IPF.
With these favorable findings, Insilico was able to advance the potentially first-in-class IPF drug to first-in-human studies with 8 healthy volunteers in Australia, successfully demonstrating clinical proof-of-concept.
The following Phase 1 clinical trial with 80 healthy volunteers was a double-blind, placebo controlled, single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetic of the compound. In the study, the healthy volunteers were enrolled in 10 cohorts consisting of 5 single ascending dose and 5 multiple ascending dose cohorts. The clinical study sought to determine maximum tolerated dose for a drug requiring regular peroral administration for the entire lifetime with very high safety requirements and establish dosage recommendations for future Phase 2 studies.