Alex Zhavoronkov, Left, Founder and CEO of Insilico Medicine, and Feng Ren, Co-CEO and Chief Scientific Officer, at the corporate’s robotics lab in Suzhou, China.
Source: Medycyna Insilico
The primary fully AI-generated drug entered human clinical trials this week.
Insilico Medicine, a Hong Kong-based biotech start-up with greater than $400 million in funding, has developed INS018_055 to treat idiopathic pulmonary fibrosis, a chronic disease that causes scarring within the lungs. The disease, whose incidence has increased in recent many years, now affects about 100,000 people in america and, in accordance with the National Institutes of Health, can result in death in two to 5 years if left untreated.
“That is the primary fully generative AI drug to enter human clinical trials, specifically phase II trials involving patients,” Alex Zhavoronkov, founder and CEO of Insilico Medicine, told CNBC. “While there are other AI-designed drugs in research, ours is the primary drug to have each a latest AI-discovered goal and AI-generated novel design.”
The brand new drug discovery process began in 2020 with hopes of making a drug “to the moon” that may overcome the challenges of current treatments for the disease, which mainly focus on slowing progression and could cause unpleasant unwanted side effects, Zhavoronkov said.
He added that Insilico selected to focus on IPF partially due to the disease’s implications for aging, but the corporate has two other drugs partially AI-produced within the clinical stage. One is a Covid-19 drug in Phase 1 clinical trials, and the opposite is an anti-cancer drug, specifically a “USP1 inhibitor for the treatment of solid tumors,” which recently received FDA approval to start clinical trials.
“When this company was founded, we focused on algorithms – developing technology that may discover and design latest molecules,” said Zhavoronkov. “At first, I never imagined I might take my very own AI drugs into clinical trials with patients. But we realized that to validate our AI platform, we needed to not only design a latest drug for a latest goal, but put it into clinical trials to prove that our technology worked.”
The present study of IPF is a 12-week randomized, double-blind, placebo-controlled study in China, and Insilico plans to expand the trial population to 60 people at 40 centers within the US and China. If the present Phase 2 trial is successful, one other trial with a bigger cohort might be conducted, followed by potentially Phase 3 trials involving a whole bunch of participants.
“We expect to have results from the present Phase II trial next 12 months,” Zhavoronkov said, adding that it’s difficult to predict the precise timing of future phases, especially for the reason that disease is comparatively rare and patients must meet certain criteria. He added: “We’re optimistic that this drug might be able to go to market and reach patients who may benefit from it in the subsequent few years.”