Insilico Medicine reports positive top-line results of

NEW YORK, Jan. 10, 2023 (GLOBE NEWSWIRE) — Insilico Medicine (“Insilico”), an artificial intelligence (AI)-based clinical-stage drug discovery and development company, today reports positive top-line safety results , safety and pharmacokinetics (PK ) from the phase 1 clinical trial of INS018_055, a potential first-in-class drug discovered by Insilico’s end-to-end AI platform for idiopathic pulmonary fibrosis (IPF).

“Topline data from our phase 1 study of INS018_055 demonstrates the ability of our Pharma.AI platform to discover new targets and design novel molecules with a high level of translation to human biology,” said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine “This flagship program paves the way for a new era in drug discovery and development that leverages next-generation AI to identify novel targets and develop novel drugs to treat diseases that require regular oral drug delivery via the human body entire lifetime with very high safety requirements.”

Idiopathic pulmonary fibrosis (IPF) is a type of chronic scarring lung disease characterized by a progressive and irreversible decrease in lung function, affecting approximately 5 million people worldwide. IPF has a poor prognosis with a median survival of 3 to 4 years and represents a significant unmet medical need. INS018_055 is the first small molecule antifibrotic inhibitor developed by Insilico’s drug discovery platform Pharma.AI with a newly discovered target and a novel structure designed by AI was developed.

The phase 1 INS018_055 study was a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study to evaluate safety, tolerability, pharmacokinetics, food effects and drug interaction potential (DDI ) of INS018_055 in 78 healthy subjects in New Zealand (NZ). Insilico Medicine’s Phase 1 clinical trial enrollment was initiated in February 2022 and the subject’s final follow-up visit was completed in November 2022. Safety and PC data collection was completed for both the SAD and MAD cohorts.

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The observed human PK of INS018_055 in healthy subjects was consistent with the company’s preclinical modeling with no significant accumulation at 7 days and presented a favorable PK profile. INS018_055 was generally safe and well tolerated in healthy volunteers in the study. No deaths or SAEs were reported during the study. One subject receiving INS018_055 in the 30 mg once daily MAD cohort discontinued study treatment due to moderate TEAE of an influenza-like illness that was considered unrelated to study treatment. All treatment-related AEs were mild in severity and resolved by the end of the study.

Based on these results, Insilico anticipates initiating a Phase 2a study of INS018_055 in IPF patients in early 2023. The Company expects to provide additional data from this Phase 1 study in future updates.

“There remains a high unmet medical need for idiopathic pulmonary fibrosis, and INS018_055 targets important activated signaling cascades that contribute significantly to the pathogenesis of pulmonary fibrosis with both antifibrotic and anti-inflammatory activity,” said Sujata Rao, PhD, SVP, Head of the global clinical development at Insilico Medicine. “The results of this study are encouraging regarding the safety and tolerability of INS018_055 and will be incorporated into an FDA regulatory submission. Subject to agency approval, we expect to initiate the Phase 2a study in early 2023.”

“INS018_055 is the first AI-designed novel molecule for an AI-discovered novel target to enter a clinical trial,” said Feng Ren, PhD, Chief Scientific Officer and Co-CEO of Insilico Medicine. “The top-line data shows good PK and tolerability of the drug in healthy volunteers in both SAD and MAD, which is very encouraging. The positive phase I data allow for further evaluation of drug efficacy in IPF patients in the phase 2 study. Furthermore, the continued progress of INS018_055 further demonstrates the power of our AI platform in drug discovery and development.”

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For more information about the Insilico clinical trial, visit (ID NCT05154240).

About insilico medicine

Insilico Medicine, a clinical-stage, artificial intelligence (AI)-powered drug discovery company, connects biology, chemistry and clinical trial analysis using next-generation AI systems. The company has developed AI platforms that leverage deep generative models, reinforcement learning, transformers and other advanced machine learning techniques to discover novel targets and generate novel molecular structures with desired properties. Insilico Medicine develops breakthrough solutions to discover and develop innovative medicines for cancer, fibrosis, immunity, central nervous system disorders, infectious diseases, autoimmune diseases and age-related diseases.


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