Biotech begins human trial of drug designed by artificial intelligence

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A biotech company backed by Chinese conglomerate Fosun Group and private equity giant Warburg Pincus has begun one of the first mid-stage human trials of a drug discovered and designed by artificial intelligence.

Insiliko Medicines, which was founded by Latvian-born scientist Alex Zhavoronkov, said it had approved a new therapy to treat idiopathic pulmonary fibrosis (IPF), a chronic lung disease, in a patient in China.

The company said the drug, INS018_055, was the first fully “AI-discovered and AI designed” drug to begin Phase 2 clinical trials and represented a significant milestone for the industry.

“For Insilico, this is the moment of truth. , , But it’s also a true test for AI and the whole industry should see it,” Zhavoronkov said in an interview.

“Our company, and this is a big, bold claim, can double the productivity of almost every big pharma company”.

Insilico is one of a new generation of biotechs that have collectively raised billions of dollars to develop AI tools aimed at revolutionizing drug development. According to one, it is part of a race by Big Pharma and investors to capitalize on the $50 billion market opportunity for AI in the region. morgan stanley report,

Zhavoronkov said Insilico’s AI platform could potentially cut drug discovery time in half and reduce the cost of bringing drugs to market. Estimated by Deloitte $2.3 billion per therapy on average. Sanofi, Fosun and Johnson & Johnson are among several pharma companies that signed partnership deals giving them access to Insilico’s technology, he said.

AI platforms can crunch vast amounts of data to rapidly identify drug targets – proteins in the body associated with particular diseases – and molecules that can be made into drugs.

Several biotechs have recently announced drugs discovered or developed using AI and machine learning tools that have advanced into clinical trials, including Excientia, Verge Genomics, and Recursion Pharmaceuticals. Insilico uses generative AI to rapidly select new drug targets and then design new molecules that can target a particular disease.

Zhavoronkov said Insilico’s AI could save two to four years in pre-clinical discovery, depending on the novelty and complexity of the target. This did not save much time in clinical development but improved the drug’s chances of success due to better chemistry and target selection. Insilico also used AI to recruit patients who were more likely to respond to therapy, he said.

There is no guarantee that AI-discovered drugs or the platforms that build them will be successful, and some critics warn that the technology’s potential has been exaggerated. Last month Benevolent AI, a London-based biotech with AI drug discovery platform, said it would lay off 180 employees, about half of its workforce, following the failure of its lead drug candidate.

Eric Topol, founder and director of the Scripps Research Translational Institute, said AI has already shown great potential in reducing the time and cost of drug development, even though regulators have yet to approve a fully developed drug using the technology. given.

“There is no dearth of interest. Every major pharma company has invested in partnerships with at least one, if not multiple, AI companies,” said Topol, author of intensive careA book exploring the potential of AI in healthcare.

Insilico, which is headquartered in Hong Kong and New York, has raised over $400 million to date from investors primarily based in Asia and the Americas. It has used an AI platform to select 12 pre-clinical drug candidates, three of which have advanced to clinical trials.

Zhavoronkov said the company has decided to take its IPF therapy into the clinic rather than partner with a large pharma company to retain control of its flagship program and refine its own AI platforms.

“Being able to generate large amounts of data is extremely important in ensuring that your AI is robust, as well as ensuring that it is constantly learning,” he added. “We are paving the way for a new type of AI that can go from end to end. , , That’s why we span the entire pharmaceutical R&D lifecycle,” he said.

Insilico conducted a Phase 1 trial on INS018_055 in New Zealand and China, which it said produced favorable results that support the Phase 2 trial. This mid-stage trial will enroll 60 people with IPF in China and the US to assess the drug’s safety, tolerability and preliminary efficacy.