Insilico Medicine, a Hong Kong-based artificial intelligence (AI)-powered drug discovery company, has completed the first dose of an AI-discovered drug in a Phase 2 clinical trial.
The company is evaluating INS018_055 on pulmonary function in patients with idiopathic pulmonary fibrosis (IPF).
According to the company, INS018_055 may be a first-in-class anti-fibrotic small molecule inhibitor discovered and designed by Insilico’s AI platform.
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of 12-week oral administration of INS018_055 in patients with IPF. The trial will have four cohorts, with patients receiving 30 mg once daily (QD), 30 mg twice daily (BID), 60 mg QD, or placebo.
Insilico plans to recruit 60 patients at 40 sites in China and the United States. The company began enrollment at its China-based facility in April 2023 and received approval from the US Food and Drug Administration (FDA) for a concurrent clinical trial in the US in June 2023.
Phase I study results
In January, Insilico announced positive topline data from a Phase I healthy volunteer trial. This study utilized single escalating doses (SAD) and multiple escalating doses (MAD) to evaluate the safety, tolerability, PK profile, dietary effects, and drug interactions of INS018_055.
Based on subjective and objective tests, the primary endpoint measured the number of participants with treatment-related adverse events. The study recruited 78 healthy volunteers residing in New Zealand.
Data analysis showed that the observed PK profile was favorable and consistent with preclinical models, with no significant accumulation after 1 week. The drug was generally safe and well tolerated, and no deaths or serious adverse events were reported in this study.
In February, the FDA granted Orphan Drug Designation (ODD) to INS018_055 for the treatment of IPF.
Insilico’s clinical pipeline
Beyond the IPF indication, Insilico is developing AI-generating drugs in other diseases as well.
Shortly after receiving the IPF drug’s ODD, the company announced plans to initiate a clinical trial in China evaluating ISM3312 in patients with COVID-19, with the aim of providing an alternative treatment for post-pandemic health care. bottom.
In preclinical studies, ISM3312 reduced viral load in lung tissue and reduced lung inflammation.
In April, Insilico announced that it had discovered a potent, selective and orally bioavailable small-molecule inhibitor of cyclin-dependent kinase 8 (CDK8) to treat cancer.
Scenery of IPF
IPF is the most common subtype of idiopathic interstitial pneumonia (IIP) characterized by lung tissue damage and scarring. GlobalData’s competitive landscape report estimates that the most prevalent cases diagnosed with IPF in 2028 will be in China and India.
Expert Insights recently published by GlobalData points out that there are only a few treatments approved for IPF. The late-stage clinical pipeline is small but growing slowly with several Phase III trials investigating agents for this unmet need indication.
