Insilico Medicine shares positive topline results of phase 1 trial of AI-designed drug for AI-discovered target

pharmafile | January 10, 2023 | News story | Medical Communications  

Clinical stage AI-driven drug R&D company, Insilico Medicine, has announced positive topline results from its phase 1 trial assessing the safety, tolerability and pharmacokinetics (PK) of INS018_055.

INS018_055 is Insilico Medicines’ new drug candidate which has been discovered by the company’s end-to-end AI platform. The drug is intended to treat idiopathic pulmonary fibrosis (IPF). This chronic scarring lung disease often leads to progressive and irreversible decline in lung function and affects approximately 5 million people worldwide. The average survival following an IPF diagnosis can be as little as three to four years, so new treatment options are needed.

This drug is the first anti-fibrotic small molecule inhibitor to have been discovered by Insilico’s AI-powered drug discovery platform.

The phase 1 trial assessed both a single ascending dose (SAD) and multiple ascending doses (MAD) to assess the safety, tolerability, PK, food effects, and drug-drug interaction of INS018_055 in 78 healthy volunteers.

Sujata Rao, PhD, SVP, head of global clinical development at Insilico Medicine, commented: “There remains a high unmet need for idiopathic pulmonary fibrosis, and INS018_055 targets major activated signaling cascades that significantly contribute to the pathogenesis of lung fibrosis with both anti-fibrotic and anti-inflammatory activity. Results from this study are promising for safety and tolerability of INS018_055 and will be incorporated into a regulatory submission to the FDA. Pending approval by the Agency, we expect initiation of the phase 2a study in early 2023.”


Betsy Goodfellow

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