Insilico Medicine, headquartered in Hong Kong with branches spanning across the globe, achieved this milestone one month earlier than expected, which will further accelerate its business colonization across China.
Insilico Medicine (Chinese: 英矽智能) recently announced that its application for Phase I clinical trial of class 1 drug, INS018_055, the first artificial intelligence (AI)-powered anti-idiopathic pulmonary fibrosis (IPF) drug worldwide, was approved by the Center for Drug Evaluation (CDE) in China.
According to Drug Registration Regulation of China, class 1 drugs are deemed as innovative drugs that have not been marketed in China or overseas. They are characterized as containing new compounds with clear structures and pharmacological effects as well as being clinically valuable.
INS018_055, discovered and designed via Insilico Medicine’s proprietary end-to-end AI platform Pharma.AI, is a first-in-class small molecule inhibitor with novel targets and novel chemical structures to treat IPF.
IPF is a serious chronic disease that affects the air sacs in patients’ lungs. IPF causes thick scar tissue to grow within the lungs and makes it hard to breathe, the process of which is called fibrosis and will ultimately lead to human death if without early interventions. Certain appropriate treatments can slow the progression of IPF and extend the patient’s lifespan.
The Phase 1 clinical trial has also been granted the ethic approval from clinical institutions. It will be a double-blind, placebo-controlled, single-dose and multiple-dose-escalation study. The trial is aimed to evaluate the safety, tolerability and pharmacokinetics of oral administration in healthy subjects. 48 healthy volunteers will be administered in six different cohorts which include three single-dose-escalation cohorts and three-multiple-dose-escalation cohorts.
Insilico Medicine's competitors include Exscientia, Atomwise and XTalPi.