Is this a dash of the future brought to life? The first-ever drug fully conceived and birthed by artificial intelligence is finally getting its time in the limelight, under the scrutiny of clinical trials with real, breathing, human patients.
A Leap in Biotech Innovation
The brains behind this marvel is Insilico Medicine, a biotech startup that hails from Hong Kong, and has managed to gather an impressive war chest of over $400 million in funding. They’ve christened this ground-breaking medicine INS018_055, and it’s geared towards tackling idiopathic pulmonary fibrosis – a gnarly chronic disease that scars the lungs.
To give you an idea of the size of the problem, this particular ailment has seen a spike in prevalence over the last few decades. It’s currently a thorn in the side of about 100,000 people in the U.S. alone. And without proper treatment, the prognosis is grim: death within two to five years, according to the National Institutes of Health.
Not Just Another Drug
But here’s what sets this apart: it’s not just an AI-designed drug, but the first fully generative AI drug to reach human clinical trials, and we’re talking about Phase II trials with patients, as mentioned by Alex Zhavoronkov, the founder and CEO of Insilico Medicine.
A Solution Born of Necessity
The creation of this drug kicked off back in 2020, with the lofty ambition to concoct a “moonshot” medicine that could offer relief from the limitations of current treatments for idiopathic pulmonary fibrosis. Current solutions mostly aim to slow down the disease’s progression and often come with a sidecar of uncomfortable side effects.
But Insilico isn’t stopping with just IPF. They’ve got their sights set on aging implications and have two other drugs partially generated by AI currently in the clinical stage. One is a Covid-19 drug undergoing phase one clinical trials, and the other is a cancer drug – a “USP1 inhibitor for the treatment of solid tumors,” which just got the green light from the FDA to initiate clinical trials.
The Journey Ahead
The clinical trial for the IPF drug is a randomized, double-blind, placebo-controlled trial that will run over 12 weeks in China. And Insilico isn’t limiting the scope of this trial to China alone – they have plans to expand the testing population to 60 subjects at 40 sites in the U.S. and China. If all goes according to plan and the current phase two study proves successful, it will lead to another study with a larger cohort, and then potentially advance to phase three studies with hundreds of participants.
So, what’s the timeline? Zhavoronkov says that results from the current Phase II trial should be available next year, but pinpointing an exact timeline for future phases is a bit of a guessing game. The disease isn’t exactly widespread and patients need to meet specific criteria. That being said, there’s a glimmer of optimism that this drug will be ready for market and reach patients who may benefit from it in the next few years.