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Insilico Medicine, a pioneer in AI-designed pharmaceuticals, has started Phase II trials for its primary drug candidate INS018_055, designed to treat idiopathic pulmonary fibrosis (IPF).
The drug, a small molecule inhibitor discovered using generative AI, is being tested in parallel studies in China and the U.S., both double-blind, placebo-controlled, randomized trials.
Following these studies, Insilico plans to test INS018_055 on larger groups by recruiting 60 IPF patients from around 40 sites in both China and the U.S.
Insilico’s CEO, Alex Zhavoronkov, revealed that the drug’s undisclosed "Target X" is a regulator of three pathways linked to fibrosis, namely the YAP/TAZ pathway, the Wnt pathway, and the TGF-β pathway.
Insilico believes that focusing on fibrosis-related pathways will enable the use of INS018_055 for a wider range of fibrotic conditions, such as skin fibrosis and kidney fibrosis.
With more than 10% of the global population affected by kidney disease often linked with kidney fibrosis, this represents a potential large market for Insilico, along with IPF, which affects approximately five million people globally.
Insilico anticipates that the loss of exclusivity for existing IPF treatments will open up opportunities for INS018_055, which has shown promising results in preclinical studies and is expected to outperform current standard treatments.
Enrollment for the Phase II studies might be slow due to the rarity of IPF, stringent criteria for patients to enter the studies, and competition from other drug developers conducting IPF treatment studies.
