AI-discovered drug enters Phase II trials, first patients dosed in the US, China

Phase I trials were conducted in New Zealand and China, and the drug was found to be safe for use.
Ameya Paleja
AI can quicken the pace of drug discovery while reducing costs too
AI can quicken the pace of drug discovery while reducing costs too


A drug discovered using generative artificial intelligence (AI) has now entered Phase II clinical trials, with the first dose given to patients, its inventor Insilico Medicine said in a press release. The trials occurring at multiple sites in the US and China will involve 60 subjects with Idiopathic Pulmonary Fibrosis (IPF).

The term "Generative AI" has become common knowledge these days and is associated with bots that can perform tasks like having human-like conversations or creating art or images. However, Hong Kong and New York-based Insilico Medicine have been using the technology for years to discover therapies for debilitating diseases.

Insilico Medicine is a member of chipmaker Nvidia's Inception program that offers technical training and AI platform guidance for free and was one of the first adopters of the Nvidia DGX system way back in 2015, an Nvidia release said.

How Insilico uses AI

Insilico has developed the Pharma.AI platform that offers multiple AI tools to help drug discovery. One of its tools, PandaOmics, rapidly identifies and prioritizes targets that work in favor of the disease, for instance, the spike protein on the coronavirus.

Another tool called Chemistry42 is a massive chemistry engine that designs potential drugs to target discovery from PandaOmics. The tools use generative AI to provide drug-like molecular structures generated from scratch and deep neural networks for drug discovery.

For its drug candidate against IPF, the platform delivered 80 molecules in 18 months. Conventional methods would have taken the company at least six years and more than $400 million to achieve the same result. Insilico achieved it at one-tenth the cost.

Human trials: The toughest test

The toughest test for AI-generated drug solutions is whether they can be safely used in human patients. It was in February 2021 that Insilico came up with INS018_055 as a potential drug candidate for treating IPF. The condition is a chronic lung disease, resulting in an irreversible decline in its function.

AI-discovered drug enters Phase II trials, first patients dosed in the US, China
AI-generated drugs face their ultimate test in human trials

Phase I drug trials were conducted at sites in New Zealand and China, where the drug candidate was administered to 78 and 48 healthy subjects, respectively. Across both sites, the study yielded consistent results demonstrating that the drug was safe and would be tolerated well in humans.

In February this year, the US Food and Drug Administration (FDA) granted INS018_055 an Orphan Drug designation, which denotes that the drug will help treat a condition so rare that it would not be deemed profitable for a pharmaceutical company.

Nevertheless, the drug has to undergo the same regulatory process for approval. It has now taken a significant step in the direction with the initiation of Phase II trials. This is a double-blind, randomized, and placebo-controlled trial that will test the preliminary efficacy of the drug after 12 weeks of dosage. The study subjects will be divided into four cohorts and recruited at sites in the US and China.

"The achievement of the first dose for INS018_055 in Phase II clinical trial is not only an important step for Insilico but also a milestone for AI-driven drug discovery and development," said Feng Ren, Chief Scientific Officer of Insilico Medicine said in the press release.

In addition to a potential treatment for IPF, Insilico has developed 30 more candidate drugs against various conditions, of which 12 are in the preclinical stage, and three are in the clinical stages of trials.

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