First completely AI-generated drug enters human clinical trials

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Insilico Medicine, the Hong Kong-based biotech startup, has begun human trials of its AI-designed drug.

Image source: Insilico

Known as INS018-055, the fully generative AI drug is targeted to treat idiopathic pulmonary fibrosis (IPF), a chronic disease that causes scarring in the lungs.

Image source: Canva

The condition is prevalent in about 100,000 people in the United States and, if left untreated, can lead to death in 2-5 years, according to the National Institutes of Health.

Image source: Canva

“There are very few options for people with this terrible condition, and the prognosis is poor,” said Insilico Medicine’s CEO Alex Zhavoronkov.

Image source: Insilico

Initial studies indicate that INS018_055 has the potential to address some of the limitations of existing therapies.

Image source: Canva

The drug received positive topline data in Phase I in early 2023, with international multi-site Phase I studies demonstrating consistent results.

Image source: Canva

A 12-week trial will include subjects diagnosed with IPF, and the Phase II study will assess the tolerability, safety, preliminary efficacy, and pharmacokinetics of the drug.

Image source: Canva

Insilico’s chief medical officer, Sujata Rao, M.D., stated, “If our Phase IIa study is successful, the drug will then go to Phase IIb with a larger cohort of participants.”

Image source: Insilico

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Produced by: Suchitra Shenoy Designed by: Prathamesh