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Clinical Trial News

Long-Acting Anti-TSLP Antibody HBM9378/WIN378 Enters Global Phase 2 Trial for Asthma Treatment

Monoclonal Antibody
  • Windward Bio has initiated the global Phase 2 POLARIS trial evaluating HBM9378/WIN378, a long-acting anti-TSLP monoclonal antibody for asthma treatment, with initial data expected in mid-2026.
  • The fully human antibody targets thymic stromal lymphopoietin (TSLP) and has been engineered for extended half-life with potential twice-yearly dosing, addressing the need for more effective long-acting treatments.
  • HBM9378/WIN378 demonstrated extended half-life, low antidrug antibody incidence, and good safety profile in Phase 1 trials, with additional COPD clinical programs planned for 2026.
  • The therapy represents a collaborative effort between Harbour BioMed and Kelun-Biotech, with Windward Bio holding exclusive global licensing rights outside Greater China and select Asian countries.

NeuroOne Receives USPTO Patent Approval for Novel Neural Probe Manufacturing Technology

  • NeuroOne Medical Technologies Corporation received a notice of allowance from the U.S. Patent and Trademark Office for a strategic patent covering novel methods of making neural probe devices.
  • The patent titled "Methods for Making Probe Devices and Related Devices" protects specific manufacturing steps for probe component arrangement and electrode contact material deposition.
  • This approval strengthens NeuroOne's intellectual property portfolio, which now includes 17 issued and pending patents covering thin-film electrode technologies for neurological applications.
  • The company develops minimally invasive solutions for treating epilepsy, Parkinson's disease, dystonia, essential tremors, and chronic pain conditions.

Former Poseida CEO Kristin Yarema Named to Lead Ikena-Inmagene Merger as Companies Advance Anti-OX40 Therapy

Monoclonal Antibody
  • Ikena Oncology and Inmagene Biopharmaceuticals have appointed former Poseida Therapeutics CEO Kristin Yarema to lead the merged company ImageneBio following their anticipated July 2025 closing.
  • The merger includes a concurrent $75 million private placement and will focus on advancing IMG-007, an anti-OX40 monoclonal antibody that recently completed Phase 2a trials in atopic dermatitis and alopecia areata.
  • IMG-007 demonstrated sustained clinical activity with a 34.7-day half-life in subcutaneous formulation, supporting potential for infrequent dosing in immunological and inflammatory diseases.

A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis

NCT07037901RecruitingPhase 2
Inmagene LLC
Posted 6/17/2025

AN2 Therapeutics Partners with DNDi to Advance Oral Chagas Disease Treatment AN2-502998

  • AN2 Therapeutics and DNDi announced a collaboration to advance clinical development of AN2-502998, an oral drug candidate with curative potential for chronic Chagas disease affecting 6-7 million people worldwide.
  • The boron-based benzoxaborole compound targets CPSF3 in T. cruzi parasites, utilizing the same mechanism as acoziborole which achieved ~95% cure rates in African sleeping sickness trials.
  • Phase 1 first-in-human studies are underway with completion expected in the second half of 2025, followed by Phase 2 proof-of-concept trials planned for 2026.
  • DNDi will provide extensive clinical trial networks across Latin America and Spain, leveraging their established Chagas Clinical Research Platform to accelerate global access to this potential breakthrough therapy.

First-in-Human Trial of Oral AN2-502998

NCT07024589RecruitingPhase 1
AN2 Therapeutics, Inc
Posted 8/1/2025

Real-World Safety Data Support Mvasi Biosimilar as Viable Alternative for Retinal Disease Treatment

Real World Evidence
  • A large retrospective study of 6,230 intravitreal Mvasi injections in 1,682 eyes found low adverse event rates comparable to reference bevacizumab, with only 0.05% incidence of bacterial endophthalmitis and uveitis.
  • The study addresses critical safety concerns about off-label use of oncology-approved biosimilars in ophthalmology, providing reassurance for clinicians treating retinal conditions like neovascular age-related macular degeneration and diabetic macular edema.
  • These findings are particularly significant for Australia's public hospital system, where Mvasi has become a go-to anti-VEGF therapy following the discontinuation of subsidized Avastin from the Pharmaceutical Benefits Scheme in 2021.
  • The research provides crucial real-world evidence supporting biosimilar use in ophthalmology, potentially influencing global adoption patterns and regulatory confidence in cost-sensitive healthcare markets.

IGC Pharma Unveils AI-Powered Alzheimer's Platforms at AAIC 2025

AIDrug Discovery
  • IGC Pharma will present three scientific posters at the 2025 Alzheimer's Association International Conference showcasing proprietary AI platforms for drug discovery and early disease detection.
  • The company's MINT-AD platform uses large language models to predict cognitive decline scores using only socioeconomic data, eliminating the need for brain scans or blood biomarkers.
  • IGC's hybrid AI-powered screening pipeline rapidly identifies interactions between proprietary molecules and Alzheimer's targets including GLP-1 and CB1 receptors.
  • The innovations aim to expand access to earlier diagnosis and accelerate therapeutic discovery, particularly in low-resource settings.

Inotrem's Precision Medicine Strategy Shows Breakthrough Results for Septic Shock Treatment with Nangibotide

Precision Medicine
  • Inotrem published breakthrough precision medicine strategy for nangibotide in Intensive Care Medicine, demonstrating significant clinical improvements in septic shock patients with elevated sTREM-1 biomarker levels.
  • The study showed statistically significant organ function improvement (p=0.007) and increased shock reversal rates (+22.2%, p=0.006) in biomarker-positive patients who received nangibotide versus placebo.
  • This mechanism-based approach has regulatory approval from FDA, EMA, and PMDA, representing a new paradigm for drug development in intensive care medicine.
  • The precision medicine strategy addresses a critical unmet need in septic shock, which affects over 1.1 million people annually in the US and five main EU countries with mortality rates up to 40%.

FDA Grants Breakthrough Therapy Designation to Avidity's Del-zota for Duchenne Muscular Dystrophy

Orphan DrugRare Disease
  • The FDA has granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota) for treating Duchenne muscular dystrophy in patients with mutations amenable to exon 44 skipping.
  • Del-zota demonstrated statistically significant increases in exon skipping, substantial dystrophin production increases, and significant creatine kinase reduction to near-normal levels in Phase 1/2 trials.
  • Avidity Biosciences remains on track for a planned Biologics License Application submission at year-end 2025, with topline data from the ongoing Phase 2 extension trial expected in Q4 2025.
  • The therapy represents a novel Antibody Oligonucleotide Conjugate approach that combines monoclonal antibody specificity with oligonucleotide precision to deliver treatment directly to muscle tissue.

Ph2 Open-label Study of AOC 1044 in Duchenne Muscular Dystrophy Participants With Mutations Amenable to Exon44 Skipping

NCT06244082Active, Not RecruitingPhase 2
Avidity Biosciences, Inc.
Posted 1/22/2024

Study of AOC 1044 in Healthy Adult Volunteers and Participants With Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping

NCT05670730CompletedPhase 1
Avidity Biosciences, Inc.
Posted 11/9/2022

Global Clinical Trials Landscape for Alopecia Universalis Reveals Growing Research Activity Across Major Pharmaceutical Companies

  • A comprehensive 2025 clinical trials review reveals the current global research landscape for alopecia universalis, analyzing trial distribution across regions, phases, and sponsor types.
  • Major pharmaceutical companies including Pfizer, Johnson & Johnson, Roche, and Aclaris Therapeutics are actively participating in alopecia universalis therapeutic development programs.
  • The report provides critical insights into trial enrollment trends over the past five years and identifies prominent drugs currently in development for this severe autoimmune hair loss condition.
  • Clinical trial data is compiled from over 80 different registries worldwide, offering stakeholders comprehensive market intelligence for strategic decision-making in dermatology therapeutics.

Apollo Hospitals and Siemens Healthineers Launch AI-Driven Research Collaboration for Liver Disease Diagnostics in India

AI
  • Apollo Hospitals and Siemens Healthineers have established a research collaboration to develop AI-enabled diagnostic and imaging solutions for liver disease management, focusing on quantitative ultrasound imaging and clinical decision support tools.
  • The partnership specifically targets Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which affects 9-32% of India's population and poses significant diagnostic challenges due to its underestimated prevalence.
  • The collaboration aims to enhance early detection of liver fibrosis through AI-driven disease progression models, enabling timely interventions and cost-effective screening for improved patient outcomes.
  • A Master Research Agreement was formalized in March 2025, with an addendum signed in July 2025 establishing the framework for collaborative research on diagnostic and interventional ultrasound imaging for liver care.

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