Alex Zhavoronkov, founder and CEO of Insilico Medicine, and Feng Ren, co-CEO and chief scientific officer, at the company’s robotics lab in Suzhou, China.
Source: Insilico Medicine
The world witnessed a groundbreaking milestone as Insilico Medicine, a Hong Kong-based biotech startup with a massive $400 million funding, introduced the first-ever drug entirely generated by artificial intelligence into clinical trials involving human patients. The drug, INS018_055, was developed specifically to address idiopathic pulmonary fibrosis (IPF), a chronic lung disease responsible for scarring and affecting approximately 100,000 individuals in the United States. If left untreated, IPF can lead to fatality within two to five years, as reported by the National Institutes of Health.
Alex Zhavoronkov, the visionary founder and CEO of Insilico Medicine, expressed his excitement, stating, “It is a groundbreaking achievement as this is the first AI-designed drug to reach human clinical trials, particularly Phase II trials involving patients. While other AI-designed drugs are currently in trials, ours is unique in that it features both a revolutionary AI-discovered target and an innovative AI-generated design.”
In pursuit of creating a revolutionary medicine capable of overcoming existing challenges associated with IPF treatments, Insilico embarked on the journey of discovering this “moonshot” drug in 2020. Traditional treatments for IPF predominantly focus on slowing progression and often produce uncomfortable side effects.
IPF’s implications in the aging process motivated Insilico to prioritize its treatment. However, the company also has two other drugs in the clinical phase, both partially generated by AI. One drug is aimed at combating Covid-19 and is currently undergoing phase one clinical trials, while the other drug, an FDA-approved “USP1 inhibitor for the treatment of solid tumors,” recently obtained authorization to initiate clinical trials.
Reflecting on the company’s evolution, Zhavoronkov commented, “When we initially started this company, our primary focus was on algorithms – developing the technology capable of discovering and designing new molecules. Back then, I could never have imagined that I would be enrolled in my own AI drug’s clinical trials with real patients. However, we recognized that in order to validate our AI platform, it was crucial to not only design a new drug for a new target but also bring it into clinical trials to demonstrate the efficacy of our technology.”
The ongoing study of the IPF drug involves a randomized, double-blind, placebo-controlled trial taking place over a span of 12 weeks in China. Insilico intends to extend the trial’s reach by including 60 subjects from 40 different sites in the United States and China. If the current phase two study proves successful, it will progress to a larger cohort in another study and potentially advance to phase three involving hundreds of participants.
In terms of timeline, Zhavoronkov stated, “The results from the current Phase II trial are expected to be available next year. However, precise scheduling for future phases is challenging, particularly due to the relative rarity of the disease and the specific criteria patients must meet. Nevertheless, we maintain an optimistic outlook that this drug will be market-ready within the next few years, ultimately benefiting patients in need.”
