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Clinical Trial News

Elixir Medical's DynamX Bioadaptor Meets Primary Endpoint in INFINITY-SWEDEHEART Trial

  • The INFINITY-SWEDEHEART trial met its primary endpoint, demonstrating non-inferiority of Elixir Medical's DynamX bioadaptor compared to Resolute Onyx DES for target lesion failure (TLF) at 12 months.
  • A pre-specified landmark analysis revealed a statistically significant reduction in TLF with DynamX compared to DES after six months, indicating improved long-term outcomes.
  • The DynamX bioadaptor showed numerically lower adverse events across components of the composite endpoint, including target vessel myocardial infarction and ischemia-driven target lesion revascularization.
  • The study supports the clinical impact of the Bioadaptor in coronary artery disease treatment, potentially reducing recurring adverse events after percutaneous coronary intervention.

Arrowhead Pharmaceuticals Advances RNAi Therapies ARO-INHBE and ARO-ALK7 for Obesity Treatment

  • Arrowhead Pharmaceuticals is advancing two RNAi-based therapies, ARO-INHBE and ARO-ALK7, into clinical trials for obesity treatment, targeting novel mechanisms of action.
  • ARO-INHBE, designed to reduce hepatic expression of the INHBE gene, has shown potential in preclinical studies to reduce body weight and fat mass while preserving lean muscle mass.
  • A Phase 1/2a clinical trial for ARO-INHBE is planned, including a combination arm with tirzepatide, with regulatory clearance sought in New Zealand.
  • ARO-ALK7, the second obesity candidate, is also slated for clinical trial initiation by the end of 2024, expanding Arrowhead's pipeline in metabolic diseases.

AI-Powered Stethoscope Improves Detection of Pregnancy-Linked Heart Failure

  • A new clinical trial in Nigeria demonstrates that an AI-enhanced digital stethoscope significantly improves the detection of peripartum cardiomyopathy.
  • The AI-driven stethoscope was 12 times more effective than traditional methods in identifying heart pump weakness associated with this condition.
  • The study highlights the potential of AI in addressing pregnancy-related heart failure, particularly in regions with high prevalence rates.
  • Researchers plan further studies to assess the AI stethoscope's impact in real-world settings and diverse populations, including the United States.

Screening for Pregnancy Related Heart Failure in Nigeria

NCT05438576CompletedNot Applicable
Mayo Clinic
Posted 8/15/2022

DR.NOAH Biotech's AI-Driven ALS Drug, NDC-011, Receives FDA Approval for Phase 1 Trial

  • DR.NOAH Biotech received FDA approval for its Investigational New Drug (IND) application for Phase 1 clinical trial of NDC-011, a new drug combination for Amyotrophic Lateral Sclerosis (ALS).
  • The Phase 1 trial, set to begin in early 2025, will evaluate the bioavailability, safety, and tolerability of NDC-011 in 24 healthy adult participants in the U.S.
  • NDC-011, discovered through DR.NOAH's AI platform 'ARK,' showed efficacy in preclinical studies by delaying motor function deterioration and prolonging survival in ALS models.
  • The company aims for global market expansion and has partnered with Patheon for cGMP manufacturing of NDC-011, with Phase 2 trials expected to commence in 2026.

SHAM-PVI Trial Confirms Pulmonary Vein Isolation Efficacy in Atrial Fibrillation

  • The SHAM-PVI trial demonstrated that pulmonary vein isolation (PVI) significantly reduces atrial fibrillation (Afib) burden compared to a sham procedure.
  • PVI led to substantial improvements in patient-reported outcomes, including quality of life and symptom reduction, over a 6-month period.
  • The study provides evidence that the benefits of PVI in treating symptomatic Afib are not primarily due to a placebo effect.
  • Findings support the established role of PVI as an effective intervention for managing atrial fibrillation and improving patient well-being.

A Randomized Sham-controlled Study of Pulmonary Vein Isolation in Symptomatic Atrial Fibrillation

NCT04272762CompletedNot Applicable
East Sussex Hospitals NHS Trust
Posted 1/23/2020

Nipocalimab Shows Sustained Disease Control in Adolescents with Generalized Myasthenia Gravis

  • Nipocalimab, combined with standard of care, demonstrates sustained disease control in adolescents (12-17 years) with generalized myasthenia gravis (gMG) over 24 weeks.
  • The Phase 2/3 Vibrance-MG study shows a significant reduction in immunoglobulin G (IgG) levels and improvements in MG-ADL and QMG scores.
  • Nipocalimab is well-tolerated, with no serious adverse events reported, offering a potential new treatment option for adolescents with gMG.
  • Johnson & Johnson has submitted applications to the FDA and EMA seeking approval for nipocalimab for the treatment of gMG.

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

NCT05379634Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/5/2022

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

NCT04968912CompletedPhase 2
Janssen Research & Development, LLC
Posted 9/21/2021

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT05327114RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/23/2022

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

NCT06028438CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/15/2023

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

NCT03842189CompletedPhase 2
Janssen Research & Development, LLC
Posted 4/5/2018

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

NCT04833894RecruitingPhase 2
argenx
Posted 10/26/2021

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

NCT04951622Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 7/15/2021

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

NCT05265273RecruitingPhase 2
Janssen Research & Development, LLC
Posted 7/20/2022

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

NCT05912517RecruitingPhase 3
Janssen Research & Development, LLC
Posted 12/20/2023

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

NCT04882878CompletedPhase 2
Janssen Research & Development, LLC
Posted 8/20/2021

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

NCT04119050RecruitingPhase 2
Janssen Research & Development, LLC
Posted 8/15/2019

A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

NCT06149559RecruitingPhase 2
UCB Biopharma SRL
Posted 6/14/2024

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

NCT04991753CompletedPhase 2
Janssen Research & Development, LLC
Posted 10/14/2021

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

NCT06449651RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/11/2024

IO Biotech's Melanoma Trial of IO102-IO103 Combination Therapy to Continue

  • IO Biotech's Phase III trial of IO102-IO103 with pembrolizumab for advanced melanoma will continue following IDMC review.
  • The IDMC found no new safety signals, supporting the ongoing evaluation of the therapeutic vaccine combination.
  • The primary endpoint, progression-free survival, is projected to be reached in the first half of 2025.
  • The trial compares IO102-IO103 plus pembrolizumab to pembrolizumab alone in previously untreated patients.

Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

NCT05280314RecruitingPhase 2
IO Biotech
Posted 12/21/2023

IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

NCT05077709Active, Not RecruitingPhase 2
IO Biotech
Posted 2/14/2022

IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

NCT05155254Active, Not RecruitingPhase 3
IO Biotech
Posted 5/17/2022

Age Matters: Tailoring Treatment for Congenital Nasolacrimal Duct Obstruction in Children

  • A randomized clinical trial reveals that adding interventions like intubation or turbinate fracture to conventional probing does not significantly improve the success rate of simple Congenital Nasolacrimal Duct Obstruction (CNLDO) resolution in children aged 12-24 months.
  • In older children (24-36 months), interventions including intubation may lead to higher success rates in resolving CNLDO, suggesting age-based treatment strategies should be considered.
  • The study highlights the importance of considering patient age, surgical skills, available instruments, and parental preferences when determining the most appropriate treatment for simple CNLDO.
  • Probing alone shows high success rates (70-97%) in resolving CNLDO, aligning with the study's findings of 93.1% and 72.7% success rates for the 12-24 and 24-36 months age groups, respectively.

Childhood Leukemia Trial Shows Long-Term Remission with Targeted Therapy

  • A clinical trial (MyeChild01) testing treatment combinations for children with acute myeloid leukemia (AML) has shown promising long-term remission rates.
  • The trial included a targeted therapy that delivers chemotherapy directly into cancer cells, improving treatment outcomes for young patients.
  • One patient, Callum Kyle, diagnosed with AML at age three, has remained in remission for five years after participating in the MyeChild01 trial.
  • Cancer Research UK supports research to improve outcomes, doubling its annual spend on children's and young people's cancers in the last five years.

CAMZYOS Demonstrates Sustained Benefits in Obstructive Hypertrophic Cardiomyopathy Trial

  • Long-term follow-up data from the EXPLORER-LTE trial shows CAMZYOS (mavacamten) maintains efficacy and safety in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
  • Patients treated with CAMZYOS experienced consistent improvements in echocardiographic measures and biomarkers, such as resting LVOT gradient and NT-proBNP levels, over 3.5 years.
  • Functional capacity also improved, with most patients achieving NYHA class I, indicating a significant reduction in symptoms and enhanced quality of life.
  • CAMZYOS is the first cardiac myosin inhibitor approved in the US for symptomatic oHCM, redefining the treatment landscape for this patient population.

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