Insilico Medicine Announces Positive Results In Clinical Trial of AI-Designed Drug

Today Insilico Medicine announced positive results in Phase 1 clinical trial of their potentially first-in-class AI-discovered and AI-designed drug for idiopathic pulmonary fibrosis (IPF). The drug has completed Phase 1 clinical trials and will be advancing into Phase 2 trials with IPF patients in 2023. Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine, will speak about the results today?at the JP Morgan Healthcare Conference in San Francisco.

These results are significant because this is the first AI-designed novel molecule for an AI-discovered novel target entered into a clinical trial. These results?demonstrate the power of Insilico Medicine's AI platform in drug discovery and development.

IPF is a type of chronic scarring lung disease characterized by a 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.

"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. 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.”?

Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine

2019

On September 3, 2019, Insilico Medicine published a paper describing how they used AI to design a new molecule from scratch in 21 days and validate it in 24 days.

2021

On November 30, 2021, Insilico Medicine announced the start of the first human trial of their AI-designed drug candidate for pulmonary fibrosis. This phase was the first exploratory clinical trial of the drug in healthy volunteers in Australia.?

2022

On February 25, 2022 Insilico Medicine announced the completion of Phase 0 clinical trial and the start of the full Phase 1 clinical trial with a once-a-day oral dose of their anti-fibrotic. In this phase scientists in New Zealand tested the drug’s safety, tolerability, pharmacokinetics and the impact of food intake and other medicines on its effects.

2023

On January 10, 2023, Insilico Medicine announced positive topline results from Phase 1 trial of? their AI designed anti-fibrotic.

“INS018_055 is the first AI-designed novel molecule for an AI-discovered novel target entered into a clinical trial. 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 II trial. In addition, the continued progression of INS018_055 demonstrates again the power of our AI platform in drug discovery and development.”? ???

Feng Ren, PhD, Chief Scientific Officer and Co-CEO, Insilico Medicine.???

Topline Results?

1. Insilico Medicine announces positive topline results of safety, tolerability, and pharmacokinetics from the Phase I 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).
2. INS018_055 is the first anti-fibrotic small molecule inhibitor generated by Insilico's Pharma.AI drug discovery platform with a novel target discovered and novel structure designed by AI.
3. Enrollment in Insilico Medicine’s Phase 1 clinical trial was initiated in February 2022 and the last subject follow-up visit was completed in November 2022.
4. The INS018_055 phase 1 study was a randomized, double-blind, placebo-controlled Phase 1 study featured a single ascending dose (SAD) and multiple ascending dose (MAD) to evaluate the safety, tolerability, PK, food effects, and drug-drug interaction (DDI) potential of INS018_055 in 78 healthy volunteers in New Zealand.
5. The safety and PK data collection has been completed for both SAD and MAD cohorts.
6. The observed human PK of INS018_055 in healthy volunteers was in line with the Company’s preclinical modeling with no significant accumulation after 7 days and exhibited a favorable PK profile.
7. INS018_055 was generally safe and well tolerated by healthy volunteers in the study.
8. There were no deaths or SAEs reported during the study.
9. One subject receiving INS018_055 in the MAD 30 mg once daily cohort discontinued the study treatment due to a moderate TEAE of influenza-like illness, which was considered unrelated to the study treatment.
10. All treatment-related AEs were of mild severity and resolved by the end of the study.

Next Steps

Insilico Medicine expects to share additional data from this Phase 1 study in future updates. 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 FDA approval, the company expects to initiate Phase 2a study in early? 2023.

For more information about Insilico's clinical trial please visit ClinicalTrials.gov (Identifier NCT05154240)

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Copyright ? 2023 Margaretta Colangelo. All Rights Reserved.

This article was written by?Margaretta Colangelo.?Margaretta is a leading AI analyst consulting at Insilico Medicine. She serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center.?Twitter?@realmargaretta