INS018_055, a novel therapeutic developed by Insilico Medicine using artificial intelligence, has entered Phase 2 clinical trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This marks a significant step forward in addressing a chronic and unpredictable disease with limited treatment options.
AI-Driven Drug Discovery
Insilico Medicine has dedicated the past decade to developing AI-driven therapeutics. Their lead program, targeting IPF, has now progressed to Phase 2 human clinical trials. A study published in Nature Biotechnology details the research, revealing raw experimental data and evaluations from preclinical and clinical trials. Researchers utilized generative AI to identify an antifibrotic target and its inhibitor.
"We report phase I clinical trial data highlighting the safety and tolerability of our small-molecule inhibitor. This comprehensive approach was completed in roughly 18 months from target discovery to preclinical candidate nomination and demonstrates the capabilities of our generative AI-driven drug-discovery pipeline," the scientists stated.
Targeting TNIK with INS018_055
Leveraging AI platforms like PandaOmics and Chemistry42, researchers identified TNIK (TRAF2 and NCK interacting kinase) as a promising antifibrotic target. They then used generative AI to discover INS018_055, an inhibitor designed to block TNIK. Preclinical and Phase 1 clinical trial findings suggest the potential of AI-driven drug discovery in streamlining drug design for fibrosis and other conditions.
"To date, we have found that INS018_055 demonstrated safety and tolerability in healthy volunteers, providing a strong basis for further clinical studies in patients with IPF. Collectively, our preclinical and phase I clinical trial findings speak to the potential of AI-driven drug discovery in streamlining drug design in the setting of fibrosis and other contexts," the scientists wrote.
Phase 2 Trial Design and Objectives
The Phase 2a clinical trials of INS018_055 are being conducted in China and the US, with 60 patients enrolled at each site. These trials aim to evaluate the drug's effectiveness and continue monitoring its safety profile. Phase 1 trials primarily assess safety and identify potential side effects in a small group (20-80 people), while Phase 2 trials involve a larger group (100-300 individuals) to further evaluate effectiveness.
The Unmet Need in IPF Treatment
IPF affects 13 to 20 individuals out of every 100,000 and imposes significant direct medical costs. Studies have shown that the total direct medical costs for an IPF patient can amount to USD 26,378 annually. The economic burden, coupled with the lack of effective treatments, underscores the urgent need for innovative therapies like INS018_055.
While the initial results are promising, the scientists emphasize the need for further assessment in Phase 2 and Phase 3 clinical trials to validate these findings.
