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Clinical Trial News

Protagenic Therapeutics Secures Japanese Patent for Modified Stilbenoid Epilepsy Treatment Through 2041

  • Protagenic Therapeutics received Japanese Patent JP 7714571B on July 18, 2025, providing exclusivity for modified stilbenoid compounds to treat epilepsy and seizures until March 31, 2041.
  • The patent builds on previous UK patent protection and covers specific compounds, formulations, and medical uses for epilepsy treatment within Japan's $85 billion pharmaceutical market.
  • The global epilepsy drug market is projected to grow from $11.29 billion in 2024 to $18.74 billion by 2034, representing a 5.20% compound annual growth rate.
  • The company plans to expand patent protection to additional territories, strengthening its intellectual property portfolio for this key pipeline asset.

ZUMA-7 Trial Demonstrates Survival Advantage for Second-Line CAR-T Therapy in Refractory DLBCL

CAR-T
  • The ZUMA-7 trial remains the only randomized CAR-T therapy study to demonstrate an overall survival benefit compared to standard of care in primary refractory diffuse large B-cell lymphoma.
  • Patients who received CAR-T therapy in second-line treatment showed superior outcomes compared to those who delayed treatment until third-line, highlighting the importance of early intervention.
  • CAR-T patients experienced faster recovery and return to baseline quality of life compared to those undergoing high-dose chemotherapy and autologous transplant.
  • Long-term follow-up data from pivotal trials show approximately 35% of patients achieve durable responses, suggesting potential cure in this subset with manageable long-term toxicity profiles.

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

GSK's TIM-3 Inhibitor Cobolimab Fails Phase III Trial in Advanced Lung Cancer

Monoclonal Antibody
  • GSK's anti-TIM-3 monoclonal antibody cobolimab failed to improve overall survival in the Phase III COSTAR trial for advanced non-small cell lung cancer patients previously treated with immunotherapy.
  • The study tested both triple therapy (cobolimab plus Jemperli and docetaxel) and double combination (Jemperli plus docetaxel) against docetaxel alone, with neither meeting the primary efficacy endpoint.
  • This setback adds to a growing list of failed TIM-3 checkpoint inhibitor programs from major pharmaceutical companies including Novartis, Roche, and Bristol Myers Squibb.
  • Despite the failure, cobolimab remains in Phase II studies for liver cancer, cervical cancer, and melanoma, though GSK has not confirmed its development plans.

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

NCT04655976Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 12/8/2020

VYNE Therapeutics' Repibresib Gel Fails to Meet Primary Endpoints in Phase 2b Vitiligo Trial

  • VYNE Therapeutics announced that its phase 2b trial of repibresib gel in nonsegmental vitiligo failed to meet primary and key secondary endpoints, with only 19.5% of patients achieving F-VASI50 improvement compared to 23.4% on vehicle.
  • The trial was impacted by an unexpectedly high vehicle effect and higher dropout rates in active treatment arms (up to 36.6%) compared to vehicle (10.6%).
  • Despite the setbacks, the highest dose (3%) showed nominally significant improvements in facial vitiligo scores (-43.6% vs -25.6% vehicle) and total vitiligo scores (-28.3% vs -16.2% vehicle).
  • The company will terminate the trial's extension phase and seek a development partner for repibresib while continuing to evaluate its BET inhibitor platform for immune-mediated diseases.

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.

NCT06493578Active, Not RecruitingPhase 2
Vyne Therapeutics Inc.
Posted 6/4/2024

MAGENTIQ EYE Secures Series A Funding to Advance AI-Powered Colonoscopy Technology

AIFDA Approval
  • MAGENTIQ EYE completed its Series A funding round led by aMoon to accelerate commercialization of its FDA- and CE-approved AI colonoscopy software MAGENTIQ-COLO in the USA and Europe.
  • The company's AI-powered software significantly improves adenoma detection rates during colonoscopies and offers real-time polyp analysis with size and type estimation capabilities.
  • Funding will support ongoing clinical trials for diagnostic tools targeting ulcerative colitis, Barrett's esophagus dysplasia, and gastric intestinal metaplasia while expanding global market access.
  • The investment reflects growing commercial traction with dozens of daily procedures and a robust pipeline of trial and purchase requests across international markets.

Nautilus Biotechnology Partners with Allen Institute to Advance Alzheimer's Research Through Single-Molecule Proteomics

  • Nautilus Biotechnology has entered into an agreement with the Allen Institute to investigate the connection between tau protein and Alzheimer's disease using single-molecule proteomics technology.
  • The collaboration will employ Nautilus' Iterative Mapping method to identify novel tau proteoforms from human brain tissue and characterize phosphorylation patterns that may predict disease progression.
  • Nautilus' recent preprint demonstrates the platform's ability to analyze millions to billions of single-protein molecules with unprecedented resolution, providing actionable biological insights from brain samples of cognitively normal and impaired Alzheimer's patients.

Ionis Pharmaceuticals Reports Strong Q2 2025 Results, Raises Guidance on TRYNGOLZA Success

Drug ApprovalRare Disease
  • Ionis Pharmaceuticals delivered $19 million in net product sales for TRYNGOLZA in Q2 2025, driving a doubling of total revenue to $452 million compared to the same period last year.
  • The company raised its 2025 financial guidance for the second time this year, increasing total revenue expectations to $825-850 million from the previous $725-750 million range.
  • Donidalorsen for hereditary angioedema is on track for U.S. approval with a PDUFA date of August 21, 2025, representing Ionis' second independent product launch.
  • Phase 3 data from pivotal CORE and CORE2 studies for olezarsen in severe hypertriglyceridemia are expected in September 2025, potentially expanding the drug's market opportunity.

Cardiosense Receives FDA Clearance for CardioTag, First Wearable to Monitor Heart Rhythm and Mechanical Function

AI
  • Cardiosense announced FDA 510(k) clearance for CardioTag, the first wearable device to simultaneously collect ECG, PPG, and seismocardiogram signals for comprehensive cardiac monitoring.
  • The device enables clinicians to assess not only heart rhythm but also mechanical and hemodynamic function, providing unprecedented visibility into cardiac performance across care settings.
  • A recent multicenter study showed Cardiosense's AI algorithm for pulmonary capillary wedge pressure estimation achieved accuracy comparable to implantable hemodynamic sensors in heart failure patients.
  • The clearance represents a significant advancement in noninvasive cardiac monitoring, moving beyond traditional ECG-focused approaches to include cardiac mechanics and blood flow assessment.

FDA Grants Orphan Drug Designation to VT3989 for Mesothelioma Treatment

  • The FDA has granted orphan drug designation to VT3989, a first-in-class TEAD autopalmitoylation inhibitor developed by Vivace Therapeutics for treating mesothelioma.
  • VT3989 targets the Hippo pathway by blocking palmitoylation of TEAD proteins, which control cell growth and division processes that can lead to cancer when disrupted.
  • The drug has shown encouraging clinical activity and favorable safety profile in an ongoing Phase 1 study of over 200 patients, particularly in mesothelioma patients who failed chemotherapy and immunotherapy.
  • Vivace Therapeutics plans to discuss moving into a registrational Phase 3 study in mesothelioma with the FDA by the end of 2025.

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

NCT04665206RecruitingPhase 1
Vivace Therapeutics, Inc
Posted 3/24/2021

BioDuro and Atombeat Launch AI-Powered Platform to Accelerate Peptide Drug Discovery

AI
  • BioDuro and Atombeat have announced a strategic partnership to develop an AI-driven platform that accelerates peptide drug discovery from molecular design to preclinical candidates.
  • The collaboration combines Atombeat's AI modeling technologies, capable of exploring over one trillion peptide compounds in silico, with BioDuro's expertise in peptide chemistry and high-throughput synthesis.
  • The integrated platform enables rapid screening of peptide candidates based on key traits like membrane permeability before lab testing, followed by BioDuro's ability to produce hundreds of high-purity peptides within one week.
  • This end-to-end workflow aims to deliver faster timelines and better cost-effectiveness for developing next-generation peptide therapeutics across broad therapeutic areas.

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