HQ Team
January 13, 2023: Insilico Medicine, an artificial intelligence-driven biotech company, announced positive results from the Phase 1 clinical trial of INS018_055, its first-in-class drug for idiopathic pulmonary fibrosis (IPF).
“Topline data from our Phase 1 study of INS018_055 demonstrate the ability of our Pharma.AI platform to discover novel targets and design novel molecules with a high level of translatability to human biology,” said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. “This lead program is paving the way for a new era of drug discovery and development that utilizes next-generation AI to identify novel targets and generate novel drugs to treat diseases requiring regular peroral drug administration for the entire lifetime with very high safety requirements.”
Idiopathic pulmonary fibrosis (IPF) is a chronic progressive and irreversible decline in lung function affecting around 5 million people globally. IPF carries a poor prognosis with a median survival of 3 to 4 years and represents a significant unmet medical need. INS018_055 is the first anti-fibrotic small molecule inhibitor generated by Insilico’s Pharma.AI drug discovery.
INS018_055 Phase 1 Study
The INS018_055 Phase 1 study was a randomized, double-blind, placebo-controlled study carried out on 78 healthy volunteers in New Zealand that featured a single ascending dose (SAD) and multiple ascending doses (MAD) to evaluate the safety, tolerability, pharmacokinetics (PK), food effects, and drug-drug interaction (DDI) potential of INS018_055. The study was done from February 2022 to November 2022.
INS018_055 was generally safe and well tolerated by healthy volunteers in the study. All treatment-related AEs were of mild severity and resolved by the end of the study.
Based on these results, Insilico plans a Phase 2a study of INS018_055 in IPF patients in early 2023. The company will update on s additional data from this Phase 1 study soon.
“INS018_055 is the first AI-designed novel molecule for an AI-discovered novel target entered into a clinical trial,” said Feng Ren, PhD, Chief Scientific Officer and co-CEO of Insilico Medicine.“The topline data demonstrate good PK and tolerability of the drug in healthy volunteers in both SAD and MAD, which is quite encouraging. The positive Phase I data enable the further evaluation of the drug efficacy in IPF patients in the Phase 2 trial. In addition, the continued progression of INS018_055 demonstrates again the power of our AI platform in drug discovery and development.”
“There remains a high unmet medical 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,” said Sujata Rao, PhD, SVP, Head of Global Clinical Development at Insilico Medicine. “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.”
