MedPath

Clinical Trial News

ESC Congress 2024: Novel Insights in Heart Failure, Hypertension, and Risk Assessment

• The ESC Congress 2024 highlighted personalized care in atrial fibrillation and innovative hypertension therapies, emphasizing single-pill combinations to improve adherence. • The FINEARTS-HF trial revealed that finerenone significantly reduces heart failure escalation and hospitalizations, especially when combined with SGLT2 inhibitors. • Trials on transcatheter mitral valve repair showed it's as effective as surgery, offering a less invasive option for secondary mitral regurgitation patients. • Research indicates current cardiovascular risk assessments are inadequate, advocating for direct disease evaluation over traditional risk factor surrogates.

Lynparza Shows Promise as Non-Hormonal Therapy for Prostate Cancer with HRR Mutations

• A Phase II trial of AstraZeneca's Lynparza (olaparib) demonstrated efficacy in treating recurrent prostate cancer patients without hormone therapy, offering a potential alternative to androgen deprivation therapy. • The study found that patients with homologous recombination repair (HRR) gene mutations, particularly BRCA2 alterations, showed a significant response to Lynparza monotherapy. • Median progression-free survival was notably longer in patients with HRR mutations (22.1 months) compared to those without (12.8 months), highlighting the importance of biomarker selection. • Researchers are planning follow-up studies to confirm these findings and further explore the mechanisms underlying therapy response in patients with HRR deficiency.

eGenesis Secures $191 Million to Advance Gene-Edited Pig Kidney for Human Transplant

• eGenesis has raised $191 million in Series D financing to advance its gene-edited pig kidney program, EGEN-2784, towards human clinical trials. • The funding will support the expansion of eGenesis's production capabilities and further development of its pipeline programs focused on other organs. • eGenesis achieved the world's first successful transplant of a genetically modified porcine kidney into a living human patient in March 2024. • The company's technology addresses cross-species molecular incompatibilities and viral risks through advanced genetic engineering techniques.

FDA Grants Full Approval to Travere's Filspari for IgA Nephropathy

  • The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.
  • The approval was based on the PROTECT study, which demonstrated Filspari significantly slowed kidney function decline over two years compared to irbesartan.
  • Filspari is now positioned as a foundational, non-immunosuppressive treatment option, potentially replacing the current standard of care for IgAN patients.
  • The label update removes a specific urine protein level requirement, expanding the eligible patient population and increasing Filspari's market potential.

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

NCT03594110CompletedPhase 3
Boehringer Ingelheim
Posted 1/31/2019

Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis

NCT05517980Not Yet RecruitingPhase 2
Kira Pharmacenticals (US), LLC.
Posted 3/1/2025

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

NCT03036150CompletedPhase 3
AstraZeneca
Posted 2/2/2017

Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

NCT05248646Active, Not RecruitingPhase 3
Otsuka Pharmaceutical Development & Commercialization, Inc.
Posted 3/15/2022

BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

NCT02052219WithdrawnPhase 3
Anthera Pharmaceuticals
Posted 10/1/2014

A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 7/6/2023

A Study of Telitacicept in Patients With Primary IgA Nephropathy

NCT05799287RecruitingPhase 3
RemeGen Co., Ltd.
Posted 4/28/2023

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

NCT05797610RecruitingPhase 3
Hoffmann-La Roche
Posted 8/8/2023

Atrasentan in Patients With IgA Nephropathy

NCT04573478Active, Not RecruitingPhase 3
Chinook Therapeutics, Inc.
Posted 12/11/2020

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

NCT06291376RecruitingPhase 3
Alexion Pharmaceuticals, Inc.
Posted 3/29/2024

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

NCT03643965CompletedPhase 3
Calliditas Therapeutics AB
Posted 9/5/2018

Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

NCT05125068TerminatedPhase 2
Eledon Pharmaceuticals
Posted 3/21/2022

Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

NCT02682407Unknown StatusPhase 2
Omeros Corporation
Posted 2/1/2016

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

NCT03608033TerminatedPhase 3
Omeros Corporation
Posted 2/16/2018

An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases

NCT05732402Active, Not RecruitingPhase 1
Alpine Immune Sciences, Inc.
Posted 3/15/2023

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

NCT03762850Active, Not RecruitingPhase 3
Travere Therapeutics, Inc.
Posted 12/11/2018

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

NCT04578834Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 1/25/2021

Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

NCT05097989TerminatedPhase 2
Alexion Pharmaceuticals, Inc.
Posted 1/14/2022

Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

NCT05775042RecruitingPhase 2
Keymed Biosciences Co.Ltd
Posted 5/8/2023

Atacicept in Subjects With IgA Nephropathy

NCT04716231Active, Not RecruitingPhase 3
Vera Therapeutics, Inc.
Posted 5/23/2023

A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

NCT05047263Active, Not RecruitingPhase 3
Bayer
Posted 9/21/2021

Ascendis Pharma Gains Optimism with Potential Drug Launches and Analyst Upgrade

  • Oppenheimer upgraded Ascendis Pharma to Outperform, projecting strong sales for Yorvipath and potential in TransCon CNP.
  • Yorvipath, a hypoparathyroidism treatment, anticipates a U.S. launch by Q1 2025, driven by positive feedback from key opinion leaders.
  • Phase 3 trial results for TransCon CNP in achondroplasia are forthcoming, with market sentiment undervaluing its potential impact.
  • Despite recent sales challenges with Skytrofa, Ascendis aims for approval of all three product candidates by the end of 2025.

Decentralized Clinical Trials Show Significant Growth in 2024, Driving Improved Patient Diversity and Retention

  • Decentralized Clinical Trials (DCTs) demonstrated remarkable growth in early 2024, with 1,170 studies incorporating decentralization elements, marking a 26% increase from the same period in 2023.
  • Studies implementing mobile visits showed impressive outcomes, achieving 50% lower dropout rates in Phase III trials and 41% faster completion times compared to traditional trial formats.
  • DCTs significantly improved diversity in clinical research, with 90% of mobile visit studies including Hispanic/Latino participants compared to 60% in traditional trials, while Native American participation doubled to 30%.

Lenire Shows Consistent Real-World Effectiveness in Tinnitus Treatment

  • A real-world study of U.S. patients using Lenire demonstrated a 91.5% rate of clinically meaningful tinnitus reduction after 12 weeks.
  • The outcomes align with those from controlled clinical trials, reinforcing Lenire's potential as a reliable tinnitus treatment.
  • Lenire, an FDA-approved bimodal neuromodulation device, is available in specialized clinics and is a treatment option for U.S. Veterans.

Amneal and Shilpa's Boruzu (Bortezomib) Receives FDA Approval for Multiple Myeloma and Mantle Cell Lymphoma

  • Amneal Pharmaceuticals and Shilpa Medicare have gained FDA approval for Boruzu, a ready-to-use bortezomib injection, for subcutaneous or intravenous administration.
  • Boruzu simplifies oncology treatment by reducing preparation steps compared to Velcade, a lyophilized powder requiring reconstitution before use.
  • The drug, a proteasome inhibitor, is approved for treating multiple myeloma and mantle cell lymphoma, with a planned launch in Q2 2025.
  • Clinical studies of Boruzu reported common adverse reactions including asthenic conditions, diarrhea, nausea, and peripheral neuropathy.

A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

NCT00722566CompletedPhase 3
Millennium Pharmaceuticals, Inc.
Posted 7/1/2008

Hoth Therapeutics' HT-001 Shows Promise in Treating EGFR Inhibitor-Induced Skin Toxicities

  • Hoth Therapeutics' HT-001 demonstrated rapid improvement in papulopustular eruptions (PPEs), a common side effect of EGFR inhibitor therapy, in a patient with metastatic breast cancer.
  • The patient experienced significant symptom relief within one week of HT-001 treatment, leading to discontinuation of the therapy due to rapid healing of lesions.
  • Hoth has received IRB approval to proceed with a Phase IIa dose-ranging study of topical HT-001 for EGFR inhibitor-induced skin toxicities.
  • EGFR inhibitors often cause skin side effects, such as acneiform rashes, in up to 90% of patients, and HT-001 offers a potential solution for managing these toxicities.

Medtronic Advances Health Equity with Inclusive Pulse Oximetry Trials

  • Medtronic is conducting clinical trials to address health disparities in pulse oximetry accuracy across diverse skin tones and perfusion levels.
  • A new clinical physiology lab in Denver facilitates inclusive research, ensuring convenient access for participants from diverse backgrounds.
  • The trials aim to reduce inaccuracies in oxygen level measurements, addressing the issue of missed hypoxemic events in patients with darker skin.
  • Medtronic is actively engaging with communities to build trust and raise awareness about the importance of diverse representation in clinical trials.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.