Hong Kong-based Insilico Medicine has launched a Phase I trial of its artificial intelligence (AI)-discovered drug ISM5411.

The Phase I trial (NCT06012578) will evaluate the drug’s safety, tolerability, pharmacokinetics, and food effects in healthy volunteers. The trial is expected to enrol approximately 76 healthy volunteers across Australia, with the results expected by the end of 2024.

Insilico has completed dosing in two single ascending dose (SAD) groups and a 200mg dose group. The company plans to have seven SAD groups and three groups of multiple ascending doses (MAD) in the Phase I trial. Insilico will update the progress of the ISM5411 programme in real time on ClinicalTrials.gov, the company’s spokesperson told Clinical Trials Arena.

After the healthy volunteer study, Insilico plans to conduct a placebo-controlled Phase Ib trial in patients with UC. For this trial, the biotech plans to set up three treatment groups and one placebo group, with the specific drug dose informed by the results from the Phase Ia study. The trial will enrol patients with ulcerative colitis across multiple global trial sites, including the US and China.

Inflammatory bowel disease (IBD) is an umbrella term for Crohn’s disease and ulcerative colitis, which are characterised by chronic inflammation of the gastrointestinal (GI) tract. Sustained inflammation can cause damage to the intestinal mucosa. Common IBD treatments such as corticosteroids are aimed at easing symptoms and surgery to remove the damaged portion of the GI tract.

ISM5411 is a prolyl hydroxylase domain (PHD) enzyme inhibitor. It regulates hypoxia-inducible factor-1α (HIF-1α), which drives the expression of interstitial barrier protective genes. ISM5411 was developed using Insilico’s generative AI engine for molecule development Chemistry42.

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By GlobalData

The use of AI in drug discovery has increased in recent years, with multiple companies investing in AI. GlobalData analysts have identified more than 250 unique active drugs using terms such as “AI” or “machine learning” in their drug description in 2022, but observe that the use of AI in drug discovery is still in its infancy and is expected to mature in the coming years.

GlobalData is the parent company of Clinical Trials Arena.

Another AI-developed drug in Insilico’s pipeline includes INS018_055 for the treatment of idiopathic pulmonary fibrosis. The drug is currently being evaluated in a placebo-controlled Phase II trial. The company is also evaluating ISM3312 for the treatment of Covid-19 in clinical trials.