MedPath

Clinical Trial News

Metabolics Pharma's ENT-03 Shows Promise in Phase 1a Trial for Obesity and Type 2 Diabetes

  • Metabolics Pharma announced positive top-line results from a Phase 1a clinical trial of ENT-03, demonstrating safety and tolerability across all evaluated doses in obese and diabetic patients.
  • The novel centrally acting aminosterol showed positive trends for weight reduction and increased insulin sensitivity at higher doses, targeting brain circuits that regulate energy and metabolism.
  • ENT-03 works through Protein Tyrosine Phosphatase 1B (PTP1B) inhibitory activity and has shown additive effects when combined with GLP-1 agonists in animal models.
  • The company plans to initiate a Phase 1b study to evaluate dosing regimens in the second half of 2025, building on these encouraging first-in-human results.

£7.5 Million Longitude Prize Launches to Accelerate AI-Driven ALS Drug Discovery

AIDrug Discovery
  • The Longitude Prize on ALS has launched as a £7.5 million global challenge to incentivize AI-based approaches for drug discovery targeting amyotrophic lateral sclerosis, the most common form of motor neurone disease.
  • The competition will provide access to the largest collection of ALS patient data ever assembled, with 20 initial winners receiving £100,000 each in 2026 and a final £1 million grand prize awarded in 2031.
  • The prize is principally funded by the Motor Neurone Disease Association and aims to identify promising drug targets for a disease that currently has no long-term treatments or cure.
  • Teams will progress through multiple stages of validation, with the ultimate goal of identifying therapeutic targets with the strongest evidence of potential for treating ALS patients.

RayBiotech and Venebio Group Form Strategic Partnership to Accelerate Drug Development Through Integrated Proteomics and Regulatory Expertise

  • RayBiotech Life, Inc. and Venebio Group, LLC have entered into a Master Services Agreement to combine proteomics platforms with regulatory strategy expertise for drug and diagnostics development.
  • The collaboration integrates RayBiotech's biomarker discovery services and high-throughput protein arrays with Venebio's regulatory planning and clinical trial design capabilities.
  • The partnership aims to provide customized services from biomarker-driven trial design to clinical assay validation, helping life science companies navigate regulatory challenges more effectively.

Minerva Biotechnologies Achieves Breakthrough in Patient-Derived Stem Cell Manufacturing for Regenerative Medicine

  • Minerva Biotechnologies published research in PLOS One resolving the scientific controversy around Wnt/β-catenin pathway effects on human stem cell pluripotency versus differentiation.
  • The company's NME7AB protein enables GMP-compliant manufacturing of homogeneous naïve-state stem cells that differentiate more efficiently than traditional primed state cells.
  • iPSCs generated with NME7AB successfully differentiated into senescence-resistant mesenchymal stem cells capable of forming pure populations of chondrocytes, osteoblasts, and adipocytes.
  • This breakthrough could replace current practices using MSCs from unknown bone marrow donors with patient-derived alternatives for therapeutic applications.

Vetigenics Initiates First Dual Immune Checkpoint Inhibitor Trial in Dogs with Solid Tumors

Monoclonal Antibody
  • Vetigenics has dosed the first patient in its CHECKMATE K9 pilot study at the University of Wisconsin, combining anti-cCTLA-4 and anti-cPD-1 monoclonal antibodies in dogs with solid tumors.
  • The open-label multisite study involves seven leading veterinary oncology investigators across academic centers and aims to assess safety and preliminary efficacy signals.
  • This marks a major advancement in veterinary oncology and represents the first dual immune checkpoint inhibitor study in canine cancer treatment.
  • The research builds on landmark dual immune checkpoint inhibitor studies in human cancer and aims to strengthen the bridge between animal and human cancer research.

JiuZhou Pharma Wins China Patent Excellence Award for Breakthrough Synthesis Technology

  • JiuZhou Pharma received the 25th China Patent Excellence Award for its asymmetric hydrogenation technology using metal iridium chiral helical ligand complexes.
  • The patented technology reduced chiral intermediate costs by over 50% and supported the development of China's first domestically produced Class 1 anti-lung cancer drug.
  • This breakthrough fills a technical gap in asymmetric hydrogenation of α-keto acid compounds and opens new pathways for drug synthesis.
  • The company has accumulated 310 international and domestic patents as of 2024, demonstrating strong intellectual property capabilities.

First-in-Human iPSC-CAR-NK Cell Therapy Shows Promise for Autoimmune Disease Treatment

Gene Editing
  • Qihan Biotech's QN-139b represents the first-ever application of iPSC-CAR-NK cells in treating autoimmune disease, successfully inducing immune reset in a patient with refractory systemic sclerosis.
  • The dual-targeting therapy eliminates pathogenic B cells and plasma cells by targeting both CD19 and BCMA, incorporating nine gene edits and advanced safety features including a tEGFR safety switch.
  • After six months of treatment, the patient showed significant reduction in autoantibodies, dramatic improvement in skin scores, and histological evidence of B cell clearance and fibrosis suppression.
  • The groundbreaking clinical results were published in Cell, marking a potential breakthrough for treating severe autoimmune diseases with off-the-shelf cell therapies.

Stryker Receives FDA Clearance for Incompass Total Ankle System Integrating Dual Platform Technologies

  • Stryker has received FDA 510(k) clearance for the Incompass Total Ankle System, designed for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
  • The new platform integrates technologies from Stryker's Inbone and Infinity systems into a single comprehensive solution for total ankle replacement procedures.
  • The system incorporates data from more than 85,000 CT scans and 100,000 clinical cases to support patient-specific care and surgical efficiency.
  • Incompass features Adaptis Boney Ingrowth Technology and redesigned instrumentation aimed at improving long-term fixation and streamlined surgical workflow.

Bryn Pharma Initiates Clinical Trial for Dual-Dose Epinephrine Nasal Spray to Address Anaphylaxis Treatment Gaps

  • Bryn Pharma has dosed the first participant in a clinical trial evaluating its second-generation epinephrine nasal spray with an innovative dual-dose profile that delivers two complete therapeutic doses from a single device.
  • The upgraded nasal spray device features enhanced reliability, easier handling, improved comfort and fit, and an integrated dose indicator, addressing key limitations of current injectable epinephrine treatments.
  • The trial aims to compare pharmacokinetics, pharmacodynamics, and safety of the nasal spray against injectable epinephrine standards, with results expected in Q3 2025.
  • More than 50% of patients prescribed epinephrine autoinjectors do not carry or use them as recommended due to needle phobia, accessibility issues, and portability challenges, highlighting significant unmet medical need.

Recordati Secures Exclusive European Rights to Cardiovascular Drug Vazkepa in $175 Million Deal with Amarin

  • Recordati has acquired exclusive licensing and supply rights to commercialize Vazkepa (icosapent ethyl) across 59 European countries in a deal worth up to $175 million with Amarin.
  • Vazkepa is the only treatment proven to reduce cardiovascular risk in statin-treated patients with elevated triglycerides, backed by the REDUCE-IT study involving over 8,000 patients.
  • The drug generated €12 million in net sales across 11 European countries in 2024 and is projected to exceed €40 million in revenues by 2027.
  • The agreement includes a $25 million upfront payment and potential milestone payments up to $150 million based on sales performance thresholds starting at €100 million annually.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.