On January 10, 2023, Insilon Intelligence, a clinical stage biotech company driven by end-to-end artificial intelligence (AI), announced that INS018_055, an idiopathic pulmonary fibrosis (IPF) drug candidate, achieved positive top-line data in a Phase I trial in New Zealand, showing positive safety, tolerability, and pharmacokinetic (PK) performance. INS018_055 is a potential First-in-class drug candidate for the treatment of idiopathic pulmonary fibrosis, discovered by an Anglo-silicon intelligent end-to-end artificial intelligence platform.
Idiopathic pulmonary fibrosis (IPF) is a chronic cicatricial lung disease characterized by progressive and irreversible decline in lung function that affects approximately 5 million people worldwide. The prognostic outcome of IPF is unsatisfactory, with a median survival of 3 to 4 years and significant unmet clinical need. INS018_055 is the first anti-fibrosis small molecule inhibitor discovered by Insilon Intelligence, a novel target identified and a novel compound designed by its AI drug discovery platform Pharma.
In this randomized, double-blind, placebo-controlled Phase I study of INS018_055, researchers completed single (SAD) and multiple dose escalation (MAD) trials in 78 healthy subjects to evaluate the safety, tolerability, pharmacokinetic properties, food effects, and drug-to-drug interactions of drug candidates. Insilon initiated enrollment in February 2022 and completed follow-up of the last subject in November 2022. The Phase I trial has now completed the collection of safety and PK data in the SAD and MAD cocohort.
Study data showed that INS018_055 exhibited favorable PK characteristics in healthy subjects, with no significant accumulation observed after 7 days of administration, consistent with previous predictions in preclinical models. In addition, INS018_055 demonstrated excellent safety and tolerability, with no deaths or serious adverse events (SAE) reported during the study. The study reported one discontinuation event in a subject in the MAD cohort 30 mg QD dose group, which was discontinued due to influenza-like illness and was not related to the study drug. All treatment-related adverse effects (aes) were mild and recovered by the end of the study.
Based on these results, Insilon expects to initiate a Phase IIa study of INS018_055 in patients with IPF in early 2023, with additional data to be disclosed in the future.
