Insilico Releases Positive Top-Line Data for Phase I Clinical Trials of INS018_055 Antifibrotic Drugs

Insilico, a clinical-stage biotechnology company powered by end-to-end artificial intelligence (AI), announces that its idiopathic pulmonary fibrosis (IPF) drug candidate INS018_055 positive top-line data in a Phase I clinical trial in New Zealand with good performance in terms of
safety, tolerability, and pharmacokinetics (PK).
INS018_055 is a potential first-in-class drug
candidate for the treatment of idiopathic pulmonary fibrosis, discovered by Insilico's end-to-end AI platform.

Dr.
Alex Zhavoronkov, Founder and CEO of Insilico, said, "INS018_055 positive top-line data in the Phase 1 clinical trial further verifies the target discovery and small molecule design capabilities of Insilico's Pharma.
AI platform, and demonstrates the guiding significance
of AI computing results for drug development practice.
Insilico's leading IPF project is expected to usher in a new era of AI pharmaceuticals and leverage next-generation AI technology to aid safe oral drug development
for chronic diseases.
"

Idiopathic pulmonary fibrosis (IPF) is a chronic cicatricial lung disease characterized by a progressive and irreversible decline in lung function, affecting approximately 5 million people
worldwide.
The prognosis of IPF is unsatisfactory, with a median survival of 3 to 4 years and significant unmet clinical need
.
INS018_055 is the first anti-fibrosis small molecule inhibitor discovered by Insilico, a new target Pharma.
AI identified by its artificial intelligence drug discovery platform, and a new compound
designed.

In this randomized, double-blind, placebo-controlled phase I study for INS018_055, researchers completed single (SAD) and multiple dose escalation (MAD) trials in 78 healthy subjects to evaluate drug candidate safety, tolerability, pharmacokinetic properties, food effects, drug-drug interactions
.
Insilico initiated subject enrollment in February 2022 and ended the last subject follow-up in November of the same year, and the Phase 1 clinical trial has completed safety and PK data collection
for the SAD and MAD cohorts.

The study data showed that INS018_055 showed good PK characteristics in healthy subjects, with no significant accumulation found after 7 days of dosing, consistent with
the predictions of previous preclinical models.
In addition, INS018_055 showed good safety and tolerability, with no deaths or serious adverse events (SAEs) reported
during the study period.
The study reported one discontinuation event in which participants in the MAD cohort 30 mg QD dose group were discontinued due to influenza-like illness, an adverse event unrelated to
the study drug.
All treatment-related adverse effects (AEs) were mild and had recovered
by the end of the study.

Based on the above results, Insilico expects to initiate INS018_055 Phase 2a study in IPF patients in early 2023 and disclose more research data
in the future.

Dr.
Sujata Rao, Senior Vice President and Head of Global Clinical Development, Insilico, said, "There are still a large number of unmet clinical needs
in the IPF space.
INS18_055 targets key signaling cascades with both anti-fiber and anti-inflammatory potential
.
At present, phase I trial data have shown good safety and tolerability characteristics
.
It is expected that phase II trials will be launched next year to further verify the safety and efficacy
of drug candidates.
"

Dr.
Feng Ren, Co-CEO and Chief Scientific Officer of Insilico, said, "INS018_055 is the world's first AI-designed drug
candidate with novel mechanisms for novel targets and entering clinical trials.
Phase 1 clinical data show that the drug has good PK and tolerability in both single and multiple dose-escalation trials in healthy volunteers, which is very encouraging
.
The positive data allow us to further evaluate the efficacy
of this drug in patients with IPF in clinical phase 2 trials.
In addition, INS018_055 research advances once again demonstrate the power of
AI platforms in drug discovery.
"