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First Fully AI-Generated Drug Enters Phase II Clinical Trials for Idiopathic Pulmonary Fibrosis

AIDrug DiscoveryRare Disease
  • Insilico Medicine's INS018_055 becomes the first drug with both AI-discovered target and AI-generated design to reach Phase II clinical trials for idiopathic pulmonary fibrosis treatment.
  • The drug development process took just 30 months from target discovery to Phase I trials, approximately half the time of traditional drug discovery methods.
  • IPF affects about 100,000 people in the U.S. and typically leads to death within 2-5 years if untreated, with current treatments only slowing disease progression.
  • The Phase II trial is a randomized, double-blind, placebo-controlled study over 12 weeks in China, with plans to expand to 60 subjects across 40 sites in the U.S. and China.

Tempus Receives First FDA Clearance for AI-Based Atrial Fibrillation Risk Detection Algorithm

AIPrecision Medicine
  • Tempus received FDA 510(k) clearance for its Tempus ECG-AF device, marking the first FDA clearance for an atrial fibrillation indication in the cardiovascular machine learning-based notification software category.
  • The AI-based algorithm uses electrocardiogram data to help identify patients who may be at increased risk of atrial fibrillation and flutter.
  • This regulatory milestone represents a significant advancement in AI-enabled cardiovascular risk assessment and precision medicine applications.
  • The clearance positions Tempus to expand its AI capabilities beyond oncology into cardiovascular disease detection and prevention.

Image Analysis Group and Alimentiv Form Strategic Partnership to Advance AI-Driven Gastroenterology Clinical Trials

AI
  • Image Analysis Group (IAG) and Alimentiv announced a strategic partnership to integrate IAG's DYNAMIKA AI platform into Alimentiv's comprehensive gastroenterology clinical trial services.
  • The collaboration introduces AI-driven histology endpoints and quantitative image analysis capabilities to enhance mucosal healing assessment and inflammation severity measurement in GI trials.
  • Alimentiv brings 30+ years of GI trial experience across 60+ countries, while IAG contributes proven AI technology validated through 700+ clinical trials since 2007.
  • The partnership aims to provide deeper insights into histologic changes and drug response at the cellular level, potentially accelerating gastroenterology drug development timelines.

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

NCT03783026CompletedPhase 4
Amgen
Posted 2/6/2019

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