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Clinical Trial News

Lubiprostone Shows Promise in Slowing Kidney Function Decline in Phase II CKD Trial

  • A Phase II clinical trial demonstrated that lubiprostone, a constipation medication, suppressed kidney function decline in a dose-dependent manner in 150 patients with moderate chronic kidney disease.
  • The study revealed that lubiprostone works by increasing spermidine production and promoting gut bacterial growth, which improves mitochondrial function and provides renoprotective effects.
  • This represents the first time lubiprostone has been shown to prevent renal function decline in CKD patients, potentially offering a new therapeutic approach for a condition with limited treatment options.
  • Researchers plan to advance to Phase III trials and develop biomarkers to personalize treatment plans for CKD patients.

FDA Approves Medtronic's Evolut TAVR Systems for Expanded Redo-TAVR Indication

Drug Approval
  • Medtronic received FDA approval for expanded Redo-TAVR indication of its Evolut transcatheter aortic valve replacement systems, allowing implantation inside any failed previously implanted TAV.
  • The approval covers Evolut PRO+, FX, and FX+ systems for high-risk surgical patients with failing transcatheter heart valves from any manufacturer.
  • Medtronic launched the RESTORE study to evaluate Redo-TAVR outcomes in 225 participants over five years, focusing on procedural success rates and long-term clinical outcomes.
  • The expanded indication provides physicians with more treatment options beyond existing valve-in-valve procedures and benefits future TAVR patients by offering intervention possibilities.

UCLA Develops Off-the-Shelf CAR-NKT Cell Therapy for Metastatic Kidney Cancer

CAR-T
  • UCLA researchers have developed AlloCAR70-NKT, an innovative off-the-shelf immunotherapy that uses genetically engineered natural killer T cells to target CD70 protein on kidney cancer cells without requiring patient-specific customization.
  • The therapy demonstrated a multi-pronged attack mechanism in preclinical models, directly killing cancer cells, disrupting the tumor microenvironment, and eliminating immune cells that would normally reject donor cells.
  • This approach addresses critical limitations of traditional CAR-T therapies in solid tumors, offering potential benefits for metastatic renal cell carcinoma patients who face a five-year survival rate of just 12%.
  • The stem cell-derived therapy overcomes time delays and safety risks associated with current immunotherapies, particularly for patients with aggressive, late-stage disease.

Eli Lilly Partners with JD Health for Direct-to-Consumer GLP-1 Drug Sales in China

  • Eli Lilly has partnered with Chinese online healthcare platform JD Health International to sell its obesity and diabetes drugs through direct-to-consumer channels in China.
  • The partnership provides a comprehensive one-stop service including consultations, prescriptions, drug delivery, and follow-ups for Lilly's Mounjaro and other medications.
  • This strategic move targets China's rapidly growing GLP-1 drug market, estimated to reach $5.6-$11.4 billion annually.
  • The shift to e-commerce channels reflects China's state medical insurance policy that excludes coverage for weight loss drugs, driving pharmaceutical companies toward retail sales strategies.

NeoGenomics Wins Patent Dispute Against Natera, Clears Path for RaDaR ST Assay Commercialization

  • The U.S. District Court for the Middle District of North Carolina granted NeoGenomics' motion for summary judgment, invalidating all of Natera's asserted patent claims for ineligible subject matter.
  • The court ruling allows NeoGenomics to freely commercialize its RaDaR ST assay (formerly RaDaR 1.1) and has submitted the test to CMS for clinical reimbursement coverage.
  • Natera maintains that the invalidated patents are distinct from U.S. Patent No. 11,519,035, which previously secured an injunction against NeoGenomics' RaDaR v1.0 product.
  • Both companies operate in the competitive minimal residual disease (MRD) testing market, with Natera holding over 500 issued or pending patents worldwide and evaluating appeal options.

Orexo to Share Patent Defense Strategies Following Victory Against Sun Pharmaceutical in US Court

  • Orexo will host a seminar at Nordic Life Science Days on October 13 to share insights from its recent patent victory against Sun Pharmaceutical Industries in December 2024.
  • The Swedish pharmaceutical company has successfully defended its intellectual property against major generic challengers including Actavis/Teva in 2018 and Sun Pharmaceutical in 2024.
  • The session will provide pharmaceutical companies with strategies for building robust patent defenses before entering the US market, focusing on protecting innovations like Zubsolv for opioid dependence.
  • Industry experts from Potter Clarkson LLP and Steptoe LLP will join Orexo executives to discuss how companies can successfully defend against generic litigation challenges.

Digitoxin Reduces Death and Hospitalization Risk in Advanced Heart Failure Patients

  • The DIGIT-HF trial demonstrated that digitoxin significantly reduced the composite risk of all-cause death or hospitalization for worsening heart failure by 18% compared to placebo in patients with heart failure with reduced ejection fraction.
  • The study enrolled 1,212 patients with advanced heart failure symptoms who were already receiving optimal guideline-directed medical therapy, with 95% on beta-blockers and over 90% on renin-angiotensin system blockers.
  • Digitoxin showed particular benefit in patients with heart rates ≥75 bpm or systolic blood pressure ≤120 mmHg, while maintaining an acceptable safety profile with serious adverse events occurring in 4.7% of treated patients.
  • The findings suggest digitoxin may serve as an additional therapeutic option for heart failure patients, especially those with atrial fibrillation, higher heart rates, low blood pressure, or impaired kidney function.

Bicycle Toxin Conjugates Emerge as Novel Cancer Drug Class with Promising Clinical Results

Targeted TherapyOncology
  • Bicycle toxin conjugates (BTCs) represent a rapidly evolving field in targeted oncology that combines the binding affinity of bicyclic peptides with cytotoxic chemotherapy activity.
  • Zelenectide pevedotin (BT8009) demonstrated striking efficacy in Phase 1/2 trials when combined with immune checkpoint inhibitors, showcasing the potential of upfront combination regimens.
  • The technology offers advantages over conventional antibody-drug conjugates through deep tissue penetration and decreased systemic exposure while maintaining therapeutic activity.
  • Regulatory bodies including the US FDA are showing increasing confidence in BTCs through ramp-up programs, indicating growing institutional acceptance of this novel therapeutic approach.

FDA Recommends Enhanced Brain Monitoring for Alzheimer's Patients on Leqembi Following Six Early Deaths

Monoclonal Antibody
  • The FDA is requiring additional brain scans between the second and third Leqembi infusions after identifying six deaths early in treatment related to brain swelling complications.
  • The enhanced monitoring aims to detect amyloid-related imaging abnormalities with edema (ARIA-E), characterized by brain swelling or fluid buildup, before serious complications occur.
  • Leqembi, developed by Eisai and Biogen, was approved in 2023 as the first therapy targeting an underlying cause of Alzheimer's disease and has shown a 31% reduction in clinical decline.
  • The new monitoring requirements are more stringent than the current protocol, which recommends MRI scans before the fifth, seventh, and fourteenth infusions.

Zydus Therapeutics Reports Positive Phase 3 Results for Saroglitazar in Primary Biliary Cholangitis

Rare Disease
  • Zydus Therapeutics announced positive results from the EPICS-III Phase 2b/3 trial of Saroglitazar in Primary Biliary Cholangitis patients who had inadequate response to standard therapy.
  • The trial met its primary endpoint with a statistically significant 48.5% treatment difference in biochemical response compared to placebo (P<0.001).
  • Saroglitazar represents the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in PBC patients, with US regulatory filing planned for Q1 2026.
  • The drug was generally well tolerated with adverse events balanced between treatment and placebo groups in this rare autoimmune liver disease.

Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis

NCT05133336CompletedPhase 2
Zydus Therapeutics Inc.
Posted 4/1/2022

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