A groundbreaking development in the field of medicine has occurred as the first drug fully generated by artificial intelligence (AI) enters clinical trials with human patients. Insilico Medicine, a biotech startup based in Hong Kong that has received over $400 million in funding, has created the drug, INS018_055, as a potential treatment for idiopathic pulmonary fibrosis (IPF) – a chronic disease that causes scarring in the lungs. This condition, which has seen an increase in prevalence in recent decades, currently affects approximately 100,000 individuals in the United States. If left untreated, IPF can lead to death within two to five years, according to the National Institutes of Health.
Revolutionizing the Field of Medicine
Insilico Medicine’s CEO, Alex Zhavoronkov, revealed that this drug marks a significant milestone as it is the first fully generative AI drug to reach the stage of human clinical trials, specifically Phase II trials with patients. While there are other AI-designed drugs currently undergoing trials, INS018_055 stands out as the first drug that combines a novel AI-discovered target with a novel AI-generated design. The development process for this innovative drug began in 2020 with the aim of creating a revolutionary treatment for IPF. Existing treatments for the condition primarily focus on slowing disease progression but can cause uncomfortable side effects. Zhavoronkov expressed the motivation behind Insilico’s focus on IPF, citing the condition’s implications in the aging process. Additionally, the company has two other AI-generated drugs in the clinical stage, one targeting Covid-19 and the other focused on cancer treatment.
From Algorithms to Clinical Trials
Insilico Medicine initially started as a company dedicated to developing algorithms and technology capable of discovering and designing new molecules. However, the company’s progress has surpassed expectations, and their AI-generated drugs are now entering clinical trials with human patients. Zhavoronkov expressed his surprise at this development, highlighting the need to validate the AI platform by not only designing a new drug but also bringing it into clinical trials to demonstrate the efficacy of their technology.
Current and Future Trials
The clinical study for the IPF drug is currently a randomized, double-blind, placebo-controlled trial taking place over a span of 12 weeks in China. Insilico Medicine has plans to expand the testing population to 60 subjects across 40 sites in both the United States and China. If the ongoing phase two study proves successful, it will progress to another study involving a larger cohort. Subsequently, the drug may reach phase three studies with hundreds of participants. Zhavoronkov cautiously mentioned that predicting the exact timing for future phases is challenging, especially considering the rarity of the disease and the specific criteria patients must meet. However, he expressed optimism that the drug will be ready for the market within the next few years, benefiting patients who suffer from IPF.
In summary, the entry of the first fully AI-generated drug into clinical trials for the treatment of IPF signifies a groundbreaking advancement in the field of medicine. Insilico Medicine’s achievement showcases the potential of AI technology in revolutionizing drug discovery and development. With the promise of innovative treatments that may improve patient outcomes, the future of AI-generated drugs holds immense potential.