image: The randomized, double-blind, placebo-controlled study is being conducted across 29 clinical centers in China and has completed enrollment of the planned target of 71 patients in four participant groups, including three experimental and one placebo.
Credit: Insilico Medicine
Insilico Medicine(“Insilico”), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced the completion of patient enrollment in a Phase IIa study (NCT05938920) in China, which is investigating the safety, tolerability, and preliminary efficacy of INS018_055 for idiopathic Pulmonary Fibrosis (IPF).
The randomized, double-blind, placebo-controlled study is being conducted across 29 clinical centers in China and has completed enrollment of the planned target of 71 patients in four participant groups, including three experimental and one placebo. The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo. In addition, Insilico is preparing a Phase IIb proof-of-concept study to be initiated in 2025 to explore the efficacy and further safety of INS018_055.
“Having achieved full patient enrollment, we are looking forward to a robust dataset late in the fourth quarter of this year. Meanwhile, a parallel Phase IIa trial (NCT05975983) is ongoing and actively accruing patients in the U.S.”, said Sujata Rao, MD, Chief Medical Officer at Insilico Medicine. “We thank our clinical collaborators and participating patients and families for their continued interest and commitment. Their support contributes to our understanding of the discovery and development of innovative therapies driven by AI, in this serious chronic disease.”
Idiopathic pulmonary fibrosis (IPF), is a chronic scarring lung disease characterized by progressive and irreversible decline in lung function, affecting approximately five million people worldwide. Due to the lack of differential symptoms, patients diagnosed with IPF are often in advanced stages, with a median survival of three years. Current treatments, primarily antifibrotic agents, may slow disease progression but often fail to halt it, and they come with a range of side effects that can severely impact quality of life.
“Starting with an unmet clinical need, Insilico fast-tracked the program's early drug discovery with the support of our proprietary AI platform,” said Feng Ren, Ph.D., Co-CEO and Chief scientific officer of Insilico Medicine. “I am excited about the clinical progress in this program, which is not only another milestone achieved by Insilico's wholly owned pipeline, but also marks a step forward in the validation of AI-driven drug discovery and development. We look forward to sharing more clinical data and evaluating INS018_055 in a proof-of-concept study soon.”
In March 2024, a study published in Nature Biotechnology explained the discovery and development of INS018_055 in detail from AI algorithms to Phase II clinical trials, revealing for the first time raw experimental data as well as preclinical and parts of clinical evaluations of the potentially first-in-class TNIK inhibitor discovered and designed through generative AI.
In 2016, Insilico first described the concept of using generative AI for the design of novel molecules in a peer-reviewed journal, which laid the foundation for the commercially available Pharma.AI platform spanning across biology, chemistry and clinical development. Powered by Pharma.AI, Insilico has nominated 18 preclinical candidates in its comprehensive portfolio of over 30 assets since 2021 and has received IND approval for 7 molecules.
About INS018_055
INS018_055 is a potentially first-in-class small molecule inhibitor with a novel target discovered by Insilico’s target identification engine, PandaOmics, and a novel molecular structure designed by its generative chemistry engine, Chemistry42. In February 2021, Insilico nominated INS018_055 as a preclinical candidate for the treatment of IPF, a chronic lung disease that results in progressive and irreversible decline in lung function, and started a first-in-human study in November 2021. The FDA granted Orphan Drug Designation to INS018_055 for the treatment of Idiopathic Pulmonary Fibrosis in February 2023. Insilico initiated the enrollment Phase II clinical trial of INS018_055 in China in April 2023 and received FDA approval for a simultaneous Phase II clinical trial in the US in June 2023.
About Insilico Medicine
Insilico Medicine, a global clinical-stage biotechnology company powered by generative AI, connects biology, chemistry, and clinical trial analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and generating novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com
Reference
[1] Ren, F., et al. A small-molecule TNIK inhibitor targets fibrosis in preclinical and clinical models. Nat Biotechnol (2024). https://doi.org/10.1038/s41587-024-02143-0