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Clinical Trial News

RenovoRx Launches Multi-Center PanTheR Registry Study to Evaluate Real-World Safety of RenovoCath Device

Targeted TherapyOncology
  • RenovoRx has launched the PanTheR Post-Marketing Registry Study, a multi-center observational study designed to evaluate the long-term safety and real-world effectiveness of the FDA-cleared RenovoCath drug-delivery device in patients with solid tumors.
  • The University of Vermont Cancer Center will be the first site to initiate patient enrollment, with additional cancer centers expected to commence enrollment before the end of September 2025.
  • The registry study will capture real-world data across diverse cancer types and clinical environments, potentially informing future clinical trial designs and evidence-based treatment strategies.
  • Participating cancer centers will purchase RenovoCath devices from RenovoRx for use in the study, representing a revenue-generating opportunity for the company.

PanTheR Registry Trial

NCT06805461Recruiting
RenovoRx
Posted 8/1/2025

Filgotinib Meets Primary Endpoint in Phase 3 Trial for Axial Spondyloarthritis

  • Alfasigma's filgotinib, an oral JAK1 preferential inhibitor, successfully met the primary endpoint in the OLINGUITO Phase 3 trial for active axial spondyloarthritis (axSpA).
  • The study demonstrated efficacy across both radiographic and non-radiographic forms of axSpA, with a safety profile consistent with previous filgotinib studies.
  • Alfasigma plans to submit regulatory applications to the EMA and MHRA for market authorization, potentially offering a new oral treatment option for a condition where only 40-50% of patients achieve adequate response with current therapies.

A Study to Assess Efficacy and Safety of Filgotinib in Ankylosing Spondylitis

NCT03117270CompletedPhase 2
Galapagos NV
Posted 3/7/2017

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

NCT05785611Active, Not RecruitingPhase 3
Alfasigma S.p.A.
Posted 4/5/2023

China Medical System Secures NMPA Acceptance for ZUNVYL Alzheimer's Drug Application

Drug Approval
  • China Medical System Holdings announced that China's National Medical Products Administration has accepted the new drug application for ZUNVYL, a treatment for mild-to-moderate Alzheimer's dementia.
  • ZUNVYL is a next-generation acetylcholinesterase inhibitor that demonstrated gastrointestinal adverse events of less than 2% across all studies, potentially addressing tolerability issues that cause 55% of patients to discontinue medication after one year.
  • The drug was previously approved by the FDA in July 2024 and represents only the second oral therapy approved for Alzheimer's disease treatment in the past decade.
  • China has approximately 9.83 million patients with Alzheimer's dementia, with 7.93 million classified as mild-to-moderate cases, highlighting significant market potential for improved treatment options.

FDA Accepts Bone Mineral Density as Primary Endpoint for Entera Bio's Oral Osteoporosis Drug Phase 3 Trial

  • The FDA has agreed to accept bone mineral density (BMD) as the primary endpoint for Entera Bio's Phase 3 trial of EB613, marking a significant shift from traditional fracture-based endpoints in osteoporosis drug development.
  • This regulatory breakthrough allows for a smaller, shorter trial with just 400 patients over 24 months, reducing development costs by an estimated 70% compared to traditional fracture studies requiring 10,000+ patients.
  • EB613 is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, potentially addressing poor adherence rates of current injectable therapies in the $2.3 billion anabolic therapy market.
  • The decision is supported by SABRE initiative data showing that a 1% increase in total hip BMD corresponds to a 12-15% reduction in fracture risk, with a correlation strength of R² = 0.73.

Boehringer Ingelheim Partners with Re-Vana for $1B Extended-Release Eye Therapy Development

  • Boehringer Ingelheim and Re-Vana Therapeutics announced a strategic collaboration to develop extended-release ophthalmic therapies using Re-Vana's drug delivery technology that releases treatments over 6-12 months.
  • The partnership allows Boehringer to add up to three development programs per year, with potential total deal value exceeding $1 billion for the initial three targets plus royalty payments.
  • Re-Vana's technology aims to reduce injection frequency for eye disease patients, potentially improving treatment compliance and therapeutic outcomes.
  • Boehringer will combine the delivery platform with its existing eye health pipeline, which includes four assets currently in Phase II trials.

UCLA Study Shows Can-Fite's Piclidenoson Restores Function in Vascular Dementia Model

  • UCLA researchers led by Dr. S. Thomas Carmichael demonstrated that Piclidenoson restored tissue integrity and behavioral function in a vascular dementia mouse model with focal ischemia.
  • The study addresses a significant unmet medical need, as vascular dementia is the second most common cause of dementia with no FDA-approved therapies currently available.
  • Piclidenoson, a highly selective A3 adenosine receptor agonist, has already shown compelling safety in hundreds of psoriasis patients and could potentially capture a large share of the $6 billion vascular dementia market.
  • Can-Fite's Chief Scientific Officer noted that a first-in-class agent providing neuroprotection and improved vascular health would fill a significant treatment gap in this growing market.

Quanterix Launches First-to-Market p-Tau 205 and p-Tau 212 Assays for Alzheimer's Disease Research

  • Quanterix Corporation announced the commercial launch of two novel phospho-tau assays, p-Tau 205 and p-Tau 212, marking the first-to-market availability of these blood-based biomarkers for Alzheimer's disease research.
  • The new assays enable precise detection of tau phosphorylation sites associated with early and progressive stages of Alzheimer's disease, developed on Quanterix's ultra-sensitive Simoa® platform.
  • The company's recent acquisition of Akoya Biosciences has expanded its capabilities by integrating advanced spatial proteomics with the Human FFPE Neurobiology Panel for tissue-based analysis.
  • More than 55 posters and presentations at AAIC 2025 featured data generated using Quanterix's Simoa® technology, demonstrating its significant impact on neurodegenerative disease research.

Zymeworks Receives FDA Clearance for ZW251, Novel Glypican-3 Targeted ADC for Hepatocellular Carcinoma

Oncology
  • The FDA has cleared Zymeworks' investigational new drug application for ZW251, a first-in-class antibody-drug conjugate targeting glypican-3 for hepatocellular carcinoma treatment.
  • ZW251 incorporates Zymeworks' proprietary topoisomerase 1 inhibitor payload and demonstrated strong anti-tumor activity in preclinical studies with favorable tolerability up to 120 mg/kg in non-human primates.
  • The Phase 1 clinical trial is expected to begin in 2025, marking the second ADC from Zymeworks' pipeline to advance to clinical development using their proprietary payload technology.
  • Glypican-3 is expressed in over 75% of hepatocellular carcinoma cases, representing a significant target for this most common form of primary liver cancer.

Transgene and BioInvent to Present Updated BT-001 Oncolytic Virus Data at ESMO 2025

  • Transgene and BioInvent will present updated Phase I data on BT-001, an armed oncolytic virus expressing anti-CTLA-4 antibody, at the ESMO Annual Meeting in Berlin from October 17-21, 2025.
  • BT-001 demonstrated clinical responses in two out of six refractory patients when combined with pembrolizumab, showing shrinkage of both injected and non-injected lesions.
  • The treatment successfully converted "cold" tumors into "hot" ones by inducing T-cell infiltration and PD(L)-1 expression in the tumor microenvironment.
  • The ongoing Phase I/IIa study (NCT04725331) evaluates BT-001 as monotherapy and in combination with pembrolizumab, with the last Phase I patient enrolled in August 2024.

A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors

NCT04725331RecruitingPhase 1
Transgene
Posted 2/25/2021

Ivonescimab Demonstrates Superior Efficacy in Phase III Lung Cancer Trials, Positioning for Global Regulatory Approvals

Drug Approval
  • Ivonescimab, a PD-1/VEGF bispecific antibody, achieved a 48% reduction in progression-free survival risk compared to chemotherapy in EGFR-mutated NSCLC patients.
  • The drug outperformed pembrolizumab in head-to-head comparison with median PFS of 11.14 months versus 5.82 months in PD-L1-positive NSCLC.
  • Akeso has secured two NMPA approvals in China for 2025, while Summit Therapeutics prepares BLA filing for U.S. market entry.
  • The projected $500 million market opportunity reflects growing adoption across Asia-Pacific region with 15% CAGR expected through 2033.

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