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First fully A.I.-created drug enters clinical trials in humans

By Lee Cleveland - June 30, 2023

A groundbreaking achievement in the field of medicine has taken place as the first drug fully generated by artificial intelligence (AI) has entered clinical trials with human patients.

Insilico Medicine, a biotech startup based in Hong Kong, developed the drug, INS018_055, as a potential treatment for idiopathic pulmonary fibrosis (IPF), a chronic lung disease characterized by scarring in the lungs.

IPF is a severe condition that has seen an increase in prevalence in recent years, affecting approximately 100,000 people in the United States alone. If left untreated, it can lead to death within two to five years.

Recognizing the urgent need for more effective treatments, Insilico Medicine embarked on a mission to create revolutionary medicine using AI technology.

Alex Zhavoronkov, the founder and CEO of Insilico Medicine, expressed his excitement about this milestone, stating via CNBC, “It is the first fully generative AI drug to reach human clinical trials, and specifically Phase II trials with patients.” He further explained that while there are other AI-designed drugs in trials, INS018_055 stands out for both its novel AI-discovered target and its novel AI-generated design.

The discovery process for this groundbreaking drug began in 2020. Insilico Medicine aimed to develop a “moonshot” medicine that could overcome the limitations of current IPF treatments, which mainly focus on slowing disease progression and can cause uncomfortable side effects.

Zhavoronkov highlighted the significance of IPF not only as a serious health condition but also due to its implications in aging.

Insilico Medicine is actively working on two other drugs that are partially generated by AI and are in the clinical stage.

One of them is a COVID-19 drug currently in phase one clinical trials, while the other is a cancer drug, specifically a “USP1 inhibitor for the treatment of solid tumors,” which recently received FDA approval to initiate clinical trials.

Insilico Medicine’s journey began with a focus on developing algorithms and technology capable of discovering and designing new molecules. Zhavoronkov reflected on the early days, stating, “I never imagined in those early days that I would be taking my own AI drugs into clinical trials with patients. But we realized that in order to validate our AI platform, we needed to not only design a new drug for a new target but bring it into clinical trials to prove that our technology worked.”

The current study for the IPF drug is a randomized, double-blind, placebo-controlled trial conducted over 12 weeks in China. Insilico Medicine plans to expand the testing population to 60 subjects across 40 sites in the United States and China. If the ongoing phase two study yields positive results, the drug will proceed to further studies with larger cohorts, potentially reaching phase three studies involving hundreds of participants.

Zhavoronkov cautiously anticipates results from the current phase two trial to be available next year. However, precise timing for future phases is challenging to predict, considering the relative rarity of the disease and the specific criteria patients must meet. Nonetheless, he remains optimistic that the drug will be ready for the market in the next few years, benefiting patients in need.

The achievement of the first fully A.I.-generated drug entering clinical trials marks a significant breakthrough in the realm of medical research and showcases the potential of AI to revolutionize drug discovery and development. As Insilico Medicine continues to pioneer this innovative approach, the future holds promising prospects for more efficient and targeted treatments for a range of diseases.