Insilico Medicine – a generative artificial intelligence (AI)-driven clinical-stage biotech company – announced that it has completed the first dose in patients in the Phase II clinical trial of INS018_055, which marks the world’s first anti-fibrotic small molecule inhibitor discovered and designed by generative AI, initiating Phase II clinical trials for further evaluation.
The study is a randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 12-week oral INS018_055 dosage in subjects with IPF divided into 4 parallel cohorts. And to further evaluate the candidate in wider populations, the company plans to recruit 60 subjects with IPF at about 40 sites in both the U.S. and China. Insilico received FDA approval for the multi-regional clinical trial (MRCT) in the U.S. in June 2023 and completed the first dose in patients in China on June 19th.
INS018_055 previously received positive topline data in Phase I in early 2023. In Phase I trials carried out in New Zealand and China, INS018_055 was tested in 78 and 48 healthy subjects, divided into cohorts focusing on a single ascending dose (SAD) study and multiple ascending doses (MAD) studies. The international multi-site Phase I studies yielded consistent results, demonstrating favorable safety, tolerability, and pharmacokinetics (PK) profiles of INS018_055, supporting the initiation of the Phase II study.
Insilico is known as one of the pioneers in utilizing generative AI for drug discovery and development. And the company first described the concept of using generative AI for the design of novel molecules in a peer-reviewed journal in 2016. Insilico then developed and validated multiple approaches and features for its generative adversarial network (GAN)-based AI platform and integrated those algorithms into the commercially available Pharma.AI platform, which includes generative biology, chemistry, and medicine.
Powered with generative AI, Insilico is delivering breakthroughs for healthcare in multiple disease areas. Since 2021, Insilico has nominated 12 preclinical candidates in its comprehensive portfolio of over 30 assets and has advanced 3 of them to the clinical stage.
KEY QUOTES:
“With demonstrated potential against both fibrosis and inflammation, INS018_055 could offer another option for patients worldwide. The achievement of the first dose for INS018_055 in the Phase II clinical trial is not only an important step for Insilico, but also a milestone for AI-driven drug discovery and development. Together, we are expecting more achievements powered by AI for global unmet medical needs.”
– Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine
“When we started using generative AI for drug discovery, I never expected to reach the achievements we have today. Initiating Phase II trials with this novel inhibitor for IPF represents a major milestone for AI drug discovery. We will explore the efficacy for patients of AI-discovered and designed treatments in clinical trials, which is a true validation of our generative AI platform. We are eager to continue to advance this potentially first-in-class therapy forward to help patients in need and show the value of generative AI in drug discovery and development.”
– Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine
