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Rune Labs and Parkinson's Foundation Launch Groundbreaking Study Combining Genetic Testing with AI-Powered Digital Biomarkers

Precision MedicineAI
  • Rune Labs and Parkinson's Foundation have launched the first clinical program to correlate genetic and digital biomarkers for Parkinson's disease, supported by the Global Parkinson's Genetics Program.
  • The study combines StrivePD AI software with Apple Watch monitoring and PD GENEration genetic testing to map gene variants to real-world symptom data in Parkinson's patients.
  • Researchers aim to identify biological and digital signatures that could enable earlier diagnosis, more precise patient stratification for clinical trials, and development of personalized treatment strategies.
  • Initial genotype-response findings are expected in 2026, with the goal of moving from average-patient dosing to genome-matched therapy recommendations for the 25 million people expected to have Parkinson's by 2050.

Ochre Bio Strengthens Leadership with Former Eli Lilly and AstraZeneca Executive as RNA Therapeutics Company Expands

AIDrug Discovery
  • Oxford-based Ochre Bio has appointed Dr. Elaine Sullivan, former VP at Eli Lilly and AstraZeneca, as Senior Independent Non-Executive Director to support the company's RNA therapeutics development for chronic liver disease.
  • The company has expanded its scientific team with key hires including Dr. Julian Maller as Head of In Silico Biology and Dr. Sarah Batey as Head of Portfolio Development & Scientific Operations.
  • Ochre Bio combines AI with human data to discover RNA therapeutics and operates across Oxford, New York, and Taipei with multi-million-pound partnerships with GSK and Boehringer Ingelheim.

FDA Approves 7-Year Post-Market Study for BrainSee Alzheimer's Progression Prediction Tool

AIFDA Approval
  • The FDA has approved Darmiyan's 7-year post-market surveillance study for BrainSee, the first FDA-approved AI-powered tool that predicts Alzheimer's disease progression in patients with mild cognitive impairment.
  • BrainSee combines standard brain MRI, cognitive assessments, age, and biological sex to determine whether patients over 55 with amnestic mild cognitive impairment will progress to clinical Alzheimer's disease within five years.
  • The study will validate BrainSee's effectiveness across diverse patient populations and support pharmaceutical companies in identifying optimal candidates for next-generation Alzheimer's clinical trials.
  • Unlike traditional tests that detect amyloid beta plaques, BrainSee addresses the critical gap where roughly 40% of amyloid-positive patients remain stable and may not benefit from anti-amyloid drugs.

Oncology Clinical Trials Embrace AI and Digital Solutions to Enhance Patient-Centric Approaches

AI
  • Industry experts at the 15th Annual Clinical Trial in Oncology West Coast conference highlighted AI's transformative potential in matching the right patient populations with appropriate therapies to improve trial success rates.
  • Telehealth integration and wearable devices are being implemented to reduce patient burden and improve trial adherence, with virtual consent conferences and remote monitoring showing promise in oncology studies.
  • Pharmaceutical companies are prioritizing advancement of therapeutic agents with compelling early clinical signals while implementing "white glove" support approaches to enhance site and patient engagement.
  • Digital solutions face implementation challenges, with only 16% of breast cancer study participants using wearables, emphasizing the need for better adherence strategies and addressing privacy concerns.

Iambic Therapeutics Showcases AI-Driven Drug Discovery Platform at Multiple Investor Conferences

AIDrug Discovery
  • Iambic Therapeutics, a clinical-stage biotechnology company, will present its AI-driven drug discovery platform at six major investor conferences between April and June 2025.
  • The company's platform features advanced technologies including Enchant, a multimodal transformer model that predicts clinical outcomes, and NeuralPLexer for protein structure prediction.
  • Iambic has demonstrated the ability to complete design-make-test cycles on a weekly cadence through integration of AI-generated molecular designs with automated experimental execution.
  • The San Diego-based company, founded in 2020, is advancing a pipeline of potential best-in-class and first-in-class clinical assets to address unmet patient needs.

Hyperfine Receives FDA Clearance for AI-Enhanced Portable MRI Software, Approaching Conventional Scanner Quality

AI
  • Hyperfine's Optive AI software received FDA clearance, representing the most significant improvement to date in image quality for the company's Swoop portable MRI system.
  • Early users at select clinical sites reported image quality approaching that of conventional 1.5T MRI scanners, a notable achievement for an ultra-low-field portable device.
  • The tenth-generation software utilizes advanced AI algorithms to enhance every stage of brain imaging from noise reduction to post-processing, resulting in clearer and more anatomically detailed images.
  • Hyperfine plans to begin rollout in Q3 2025, with expectations that this advancement will support expanded hospital adoption and entry into neurology clinics.

ProteinQure Secures $11M Series A to Advance First AI-Designed Peptide Therapeutic for Triple-Negative Breast Cancer

Drug DiscoveryAIOncology
  • ProteinQure raised $11 million in Series A funding led by Heron Rock Fund to advance PQ203, a first-in-class AI-designed peptide-drug conjugate targeting triple-negative breast cancer.
  • The lead candidate PQ203 targets the sortilin receptor overexpressed in solid tumors and is designed for tumors resistant to topoisomerase I inhibitors like Trodelvy.
  • A multicenter Phase 1 clinical trial is planned to begin in Q3 2025, enrolling 70-100 patients across renowned cancer centers including Princess Margaret, MD Anderson, and Yale.
  • The financing brings ProteinQure's total funding to $16 million and represents what the company believes to be the first AI-designed peptide therapeutic entering clinical trials.

AI-Driven Clinical Decision Support System Accelerates Bacteremia Treatment by 29 Hours in Groundbreaking Study

AI
  • Arkstone Medical Solutions' AI-powered clinical decision support system delivered accurate therapeutic recommendations 29 hours faster than traditional phenotypic methods in a study of 117 bacteremia patients.
  • The OneChoice Molecular Report achieved an 80.3% concordance rate with fusion reports and demonstrated 86.3% agreement in pathogen and resistance detection compared to culture testing.
  • The study, published in Life (MDPI), represents one of the first rigorous assessments of molecular diagnostics integrated with AI-driven clinical decision support systems for bloodstream infections.
  • Escherichia coli showed 95% concordance between molecular and culture testing modalities, highlighting the efficacy of molecular testing in guiding bacteremia treatment decisions.

Enveda's AI-Discovered Anti-Inflammatory ENV-294 Clears Phase 1 Safety Trial, Advances to Atopic Dermatitis Study

AI
  • Enveda's ENV-294, a first-in-class oral anti-inflammatory derived from AI-driven natural chemistry discovery, demonstrated favorable safety and tolerability in Phase 1a trials with no dose-limiting toxicities or serious adverse events.
  • The Safety Review Committee endorsed advancement to Phase 1b trials in patients with moderate to severe atopic dermatitis, targeting a condition affecting approximately 200 million people worldwide.
  • ENV-294 showed dose-proportional pharmacokinetics supporting once-daily oral dosing, potentially addressing current treatment limitations including injectable barriers and oral therapies with black box warnings.
  • The successful Phase 1a completion validates Enveda's AI-driven drug discovery platform that translates nature's chemistry into therapeutic candidates with accelerated development timelines.

Singapore AI Platform Cuts Clinical Audit Time by 90%, Partners with Roche for Clinical Trial Acceleration

AI
  • Enigma Health's AI platform reduced clinical audit time from 528 hours to 7 hours during a pilot at Singapore National Eye Centre, analyzing over 7,000 cataract surgeries.
  • The company signed MOUs with Roche to accelerate clinical trial recruitment and with ST Engineering to enhance AI-powered healthcare applications.
  • At KK Women's and Children's Hospital, the platform cut genetic reporting time from 30 minutes per report to seconds, processing 1,400 reports in an hour instead of weeks.
  • The AI model addresses the 40% of clinical trial costs attributed to patient recruitment by rapidly identifying eligible patients based on inclusion and exclusion criteria.

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