PR99408

NEW YORK and HONG KONG, Jan. 10, 2023 /PRNewswire=KYODO JBN/ --

Insilico Medicine, a clinical stage artificial intelligence (AI)-driven drug

R&D company, today announces positive topline results of safety, tolerability,

and pharmacokinetics (PK) from the Phase I clinical trial of

INS018_055(https://clinicaltrials.gov/ct2/show/NCT05154240), 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 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," said Alex Zhavoronkov,

PhD, Founder and CEO of Insilico Medicine.  "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."

Idiopathic pulmonary fibrosis (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. INS018_055 is the first anti-fibrotic small molecule inhibitor generated

by Insilico's AI-powered drug discovery platform with a novel target discovered

and novel structure designed by Pharma.AI platform.

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 (NZ). Enrollment in Insilico Medicine's Phase 1 clinical

trial(https://www.prnewswire.com/news-releases/insilico-announces-successful-com

pletion-of-phase-0-microdose-trial-and-initiates-phase-i-clinical-trial-for-its-

first-ai-discovered-anti-fibrotic-product-candidate-with-novel-target-301489534.

html) was initiated in Feb. 2022 and the last subject follow-up visit was

completed in Nov. 2022. The safety and PK data collection has been completed

for both SAD and MAD cohorts.

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. INS018_055 was generally safe and well

tolerated by healthy volunteers in the study. There were no deaths or SAEs

reported during the study. 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.

All treatment-related AEs were of mild severity and resolved by the end of the

study.

Based on these results, Insilico expects to initiate a Phase 2a study of

INS018_055 in IPF patients in early 2023. The company expects to share

additional data from this Phase 1 study in future events.

"There remains a high unmet medical need for idiopathic pulmonary fibrosis, and

INS018_055 targets major activated signaling cascades that significantly

contribute to the pathogenesis of lung fibrosis with both anti-fibrotic and

anti-inflammatory activity," said Sujata Rao, PhD, SVP, Head of Global Clinical

Development at Insilico Medicine. "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 approval by the Agency, we expect

initiation of the Phase 2a study in early  2023."

"INS018_055 is the first AI-designed novel molecule for an AI-discovered novel

target entered into the clinical trial," said Feng Ren, PhD, Chief Scientific

Officer and co-CEO of Insilico Medicine."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."

For more information about Insilico's clinical trial please visit

ClinicalTrials.gov (Identifier

NCT05154240)(https://clinicaltrials.gov/ct2/show/NCT05154240)

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 for novel

target discovery and the generation of novel molecular structures with desired

properties. Insilico Medicine is developing breakthrough solutions to discover

and develop innovative drugs for cancer, fibrosis, immunity, central nervous

system diseases, infectious diseases, autoimmune diseases, and aging-related

diseases.

Website: www.insilico.com

Source: Insilico Medicine