News Release

Insilico announces first patient dosed in phase I study in china of its first AI-discovered anti-fibrotic drug candidate with novel target

Business Announcement

InSilico Medicine

New York, July 28 – Insilico Medicine, an end-to-end artificial intelligence (AI) -powered clinical-stage drug discovery and development company, announced that INS018_055, the company's first AI-discovered and AI-designed drug candidate for idiopathic pulmonary fibrosis (IPF), has completed its first dosing in healthy volunteers in a Phase I clinical study in China.

"The completion of the first dosing in China is an important milestone in the clinical development program for INS018_055. To our knowledge, this is the first drug discovered and designed by AI to enter the clinical stage in China,” said Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico. “Insilico has established an excellent internal clinical team to oversee the clinical study. We are progressing the global clinical development of the program at top speed to allow patients with fibrotic diseases to benefit from this novel therapeutic as soon as possible."IPF is a type of chronic scarring lung disease characterized by a progressive and irreversible decline in lung function, with a large unmet medical need globally. As the disease progresses and the lung damage worsens, the patient's respiratory function continues to deteriorate, which may eventually lead to death. INS018_055 is a potentially first-in-class small molecule inhibitor with novel target and novel molecule structure, discovered and designed by Insilico’s end-to-end AI platform, Pharma.AI. It is shown in preclinical studies that the drug candidate improved myofibroblast activation and slowed down the development of fibrosis.

The Phase I clinical study in China will be conducted in healthy volunteers to evaluate the safety and tolerability of INS018_055 at increasing oral doses and to investigate the pharmacokinetics of the drug in vivo. The study was approved by the Center for Drug Evaluation (CDE) in May 2022, making it Insilico's first clinical study in China. Previously, the drug candidate  completed a microdose study in Australia with positive results. In February, the Company initiated a Phase I clinical study in New Zealand for the drug candidate and successfully completed the single-dose study with favorable safety and tolerability results.

"IPF is a representative chronic pulmonary fibrosis disease that occurs in middle-aged and elderly populations, with a median survival time of around 2.8 years and limitations in clinical therapies," said Chen Jian, the principal leader of this study, director of the Phase I Clinical Trial Research Unit at Zhejiang Xiaoshan Hospital. "INS018_055 is a drug candidate that was rapidly discovered and designed by AI. We expect positive results from safety, tolerability and pharmacokinetic data for INS018_055 in healthy volunteers in China."

In February 2021, Empowered by PandaOmics, an AI-powered target identification engine, and Chemistry42, a small molecule generation engine, Insilico delivered the PCC for IPF treatment within 18 months for around $2.7 million. The company has nominated 8 preclinical candidates since 2021 that were discovered and designed using its proprietary AI platform in a variety of disease areas, including fibrosis, inflammation, and cancer. Most recently, Insilico announced a PCC 3CL protease inhibitor for treating COVID-19, as well as expanded synthetic lethality portfolios for immune oncology treatments.

About Insilico Medicine

Insilico Medicine, a clinical stage end-to-end artificial intelligence (AI)-driven drug discovery company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system (CNS) diseases and aging-related diseases.

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