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Phase III Clinical Trials Reveal Advances in Non-Infectious Uveitis Treatment Options

Monoclonal AntibodyDrug Approval
  • Multiple phase III trials demonstrate that locally delivered corticosteroid implants, including fluocinolone acetonide and dexamethasone devices, effectively control inflammation in non-infectious uveitis but carry significant risks of glaucoma surgery and cataract formation.
  • Adalimumab emerges as a proven biologic therapy, with VISUAL I and II trials showing 50% reduction in treatment failure risk and 43% delay in uveitis relapse, though associated with higher rates of serious adverse events including infections.
  • Comparative studies reveal that intravitreal treatments outperform periocular injections for uveitic macular edema, while suprachoroidal triamcinolone acetonide offers promising results with lower intraocular pressure elevation risks.
  • Systemic immunomodulatory therapy demonstrates comparable efficacy to methotrexate and mycophenolate mofetil as first-line treatments, with the FAST trial showing similar 67% and 57% success rates respectively in achieving uveitis control.

A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

NCT01148225CompletedPhase 3
AbbVie
Posted 11/23/2010

PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

NCT02374060CompletedPhase 3
JHSPH Center for Clinical Trials
Posted 6/16/2015

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

NCT00407082CompletedPhase 2
Bausch & Lomb Incorporated
Posted 12/1/2000

Multicenter Uveitis Steroid Treatment (MUST) Trial

NCT00132691CompletedPhase 4
JHSPH Center for Clinical Trials
Posted 9/1/2005

Phase III Study in Refractory Behcet's Disease

NCT00995709CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/1/2009

Efficacy and Safety of Adalimumab in Patients With Active Uveitis

NCT01138657CompletedPhase 3
AbbVie (prior sponsor, Abbott)
Posted 8/1/2010

First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial

NCT01232920CompletedPhase 3
University of California, San Francisco
Posted 10/1/2010

A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

NCT00333814CompletedPhase 2
Allergan
Posted 5/1/2006

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/1/2013

Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)

NCT01965145TerminatedPhase 3
Institut de Recherches Internationales Servier
Posted 11/1/2012

Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

NCT01095250TerminatedPhase 3
Novartis Pharmaceuticals
Posted 4/1/2010

Methotrexate and Mycophenolate Mofetil for UVEITIS

NCT01829295CompletedPhase 3
University of California, San Francisco
Posted 8/1/2013

Study Assessing Double-masked Uveitis Treatment

NCT01358266CompletedPhase 3
Santen Inc.
Posted 5/1/2011

Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis

NCT01385826CompletedPhase 2
Assistance Publique - Hôpitaux de Paris
Posted 6/29/2011

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

NCT00468871CompletedPhase 2
Bausch & Lomb Incorporated
Posted 4/1/2002

Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

NCT02746991CompletedPhase 3
EyePoint Pharmaceuticals, Inc.
Posted 6/2/2015

MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301

NCT02952001Completed
Clearside Biomedical, Inc.
Posted 12/13/2017

Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert

NCT01694186CompletedPhase 3
EyePoint Pharmaceuticals, Inc.
Posted 8/2/2013

Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis

NCT00344253CompletedPhase 3
Heidelberg University
Posted 3/1/2006

Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

NCT02623426CompletedPhase 3
JHSPH Center for Clinical Trials
Posted 3/9/2017

Efficacy and Safety of Adalimumab in Subjects With Inactive Uveitis

NCT01124838CompletedPhase 3
AbbVie (prior sponsor, Abbott)
Posted 8/1/2010

Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

NCT02595398CompletedPhase 3
Clearside Biomedical, Inc.
Posted 11/17/2015

ImmuneWalk's IW-601 Shows Positive Phase 1 Results in Novel Monocyte-Targeting Approach for Inflammatory Diseases

Monoclonal Antibody
  • ImmuneWalk Therapeutics announced positive topline Phase 1 data for IW-601, a first-in-class monoclonal antibody targeting MOSPD2 on myeloid cells, demonstrating safety and tolerability across all tested doses.
  • The POINTGUARD study met all primary and secondary endpoints, showing dose-proportional pharmacokinetics with a 4-week half-life and mechanistic validation through dose-dependent binding to monocytes and neutrophils.
  • IW-601's novel mechanism prevents immune cell migration into inflamed tissues without depleting blood cells, offering potential advantages over traditional therapies for multiple inflammatory conditions.
  • The company secured $7 million in seed financing and presented data at EULAR 2025, with multiple ascending dose results expected later in 2025.

Vigil Neuroscience Advances Dual TREM2 Programs with Promising Results for Neurodegenerative Diseases

Rare DiseaseMonoclonal Antibody
  • Vigil Neuroscience is on track to report final analysis from the IGNITE Phase 2 trial of iluzanebart for adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) in Q2 2025, with plans to pursue accelerated approval.
  • The company's small molecule TREM2 agonist VG-3927 demonstrated positive Phase 1 results for Alzheimer's disease, showing favorable safety, CNS penetration, and robust target engagement, with Phase 2 trials planned for Q3 2025.
  • Preclinical data presented at the AD/PD™ 2025 conference highlighted VG-3927's unique synergistic activation with endogenous TREM2 ligands like amyloid-beta, potentially enhancing potency in regions of pathology.

Biogen Advances LEQEMBI Treatment with Subcutaneous Formulation for Alzheimer's Disease

Monoclonal Antibody
• Biogen is developing a subcutaneous formulation of LEQEMBI for maintenance therapy, which could simplify treatment for Alzheimer's patients after 18 months of biweekly infusions.
• The subcutaneous administration option may increase patient adherence, reduce burden on infusion centers, and provide better accessibility for patients in rural settings.
• Fujirebio's in-vitro diagnostic tool is expected to facilitate earlier diagnosis of Alzheimer's disease, allowing treatment before significant neuronal damage occurs.

Dupilumab Shows Sustained Lung Function Improvements in COPD Patients with Type 2 Inflammation

Monoclonal AntibodyPrecision Medicine
  • Pooled data from phase 3 BOREAS and NOTUS trials demonstrate that dupilumab significantly improves lung function in COPD patients with type 2 inflammation, marking a potential advancement in personalized treatment strategies.
  • The monoclonal antibody targets interleukin-4 and interleukin-13 pathways, offering a targeted approach for this specific COPD subgroup that could transform treatment paradigms.
  • Real-world data also show dupilumab provides sustained improvements in severe asthma patients over 2 years, with over half achieving remission within 1-2 years of treatment.

Tezepelumab COPD Exacerbation Study

NCT04039113CompletedPhase 2
AstraZeneca
Posted 7/30/2019

Bimekizumab Demonstrates Sustained Three-Year Efficacy in Psoriatic Arthritis and Axial Spondyloarthritis

Monoclonal Antibody
  • UCB announced three-year data from Phase 3 trials showing bimekizumab maintained sustained control of inflammation in patients with active psoriatic arthritis and axial spondyloarthritis.
  • In psoriatic arthritis patients, 59.5% of treatment-naïve and 59.1% of TNF inhibitor-inadequate response patients achieved elimination of swollen joints at three years.
  • Axial spondyloarthritis patients demonstrated sustained clinical responses with 60.4% of non-radiographic and 60.1% of radiographic patients achieving ASAS40 response at three years.
  • Comprehensive safety analysis from pooled studies showed bimekizumab was well tolerated with no new safety signals identified over extended treatment periods.

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

NCT04242498CompletedPhase 3
UCB Biopharma SRL
Posted 3/2/2020

A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

NCT04901195Active, Not RecruitingPhase 3
UCB Biopharma SRL
Posted 5/27/2021

Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting

NCT04799990Withdrawn
AbbVie
Posted 6/23/2021

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

NCT04242446CompletedPhase 3
UCB Biopharma SRL
Posted 2/19/2020

Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis

NCT05969223Active, Not RecruitingPhase 4
AbbVie
Posted 8/10/2023

Federal Court Dismisses Sanofi's Appeal, Orders Amgen's Repatha Patent Applications to Proceed in Australia

Monoclonal Antibody
• The Federal Court of Australia has dismissed Sanofi's appeal against Amgen's PCSK9 antibody patents, ordering that Amgen's Repatha patent applications proceed to grant under Australia's pre-2013 patent laws.
• This Australian ruling contrasts with decisions in the US, where the Supreme Court invalidated similar Amgen patents for lack of enablement, highlighting significant jurisdictional differences in antibody patent protection.
• The case provides important precedent for other valuable antibody patents approaching the end of their term that are still subject to Australia's old Patent Act as biosimilars seek market entry.

ZyVersa's IC 100 Shows Promise as Disease-Modifying Treatment for Parkinson's Disease

Monoclonal Antibody
  • New research validates that microglia-driven inflammation plays a pivotal role in Parkinson's disease progression, with studies showing IC 100 can block NLRP1 inflammasome activation and reduce toxic alpha-synuclein accumulation.
  • ZyVersa Therapeutics' Inflammasome ASC Inhibitor IC 100 demonstrates potential as a disease-modifying therapy by targeting both inflammasome formation and protein aggregation, addressing underlying disease mechanisms rather than just symptoms.
  • The findings, supported by the Michael J. Fox Foundation, could represent a significant advancement for the 10 million Parkinson's patients worldwide, with ZyVersa preparing to initiate proof-of-concept studies in animal models later this year.

City of Hope to Present Groundbreaking Cancer Research at AACR Annual Meeting 2025

AIOncologyMonoclonal AntibodyPrecision Medicine
  • City of Hope researchers will present over 74 sessions at the AACR Annual Meeting 2025, showcasing innovative work in AI, precision medicine, and immunotherapies for various cancers.
  • A phase 3 clinical trial led by Dr. Aditya Shreenivas demonstrated that penpulimab combined with chemotherapy significantly improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma.
  • Novel AI tools and spatial transcriptomic technologies developed at City of Hope are advancing precision medicine approaches and revealing unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients.

CatalYm's Visugromab Shows Promise in Enhancing Antibody-Drug Conjugate Efficacy by Blocking GDF-15

Monoclonal AntibodyOncology
  • New preclinical data reveals that visugromab, CatalYm's GDF-15-neutralizing antibody, significantly enhances the anti-tumor activity of antibody-drug conjugates (ADCs) in multiple solid tumor models.
  • Research demonstrates that ADC treatment triggers GDF-15 expression as a potential resistance mechanism, which visugromab effectively counteracts by improving immune cell infiltration and activation in the tumor microenvironment.
  • These findings build on CatalYm's previous clinical evidence showing visugromab's ability to induce durable responses in relapsed/refractory solid tumors and mitigate cancer-associated cachexia.

First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)

NCT04725474Active, Not RecruitingPhase 1
CatalYm GmbH
Posted 12/9/2020

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