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Clinical Trial News

Matregenix Secures $4.2M in Contracts to Advance Nanofiber Soft Tissue Repair

  • Matregenix has been awarded three Phase II Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) contracts from the Department of the Air Force (DAF).
  • The contracts, totaling over $4.2 million, will support the development of nanofiber technologies for soft tissue repair applications within the DAF.
  • These awards bring Matregenix's total funding from AFWERX to over $4.5 million, enabling the company to advance its biomedical technologies.
  • The nanofiber solutions aim to address unmet medical needs for both military personnel and civilians, strengthening national defense capabilities.

Kintara Therapeutics Announces Corporate Updates and REM-001 Clinical Study Progress

  • Kintara Therapeutics is set to hold a special meeting on September 20, 2024, to approve its merger with TuHURA Biosciences, aiming to enhance its oncology pipeline.
  • The REM-001 study has enrolled four patients with cutaneous metastatic breast cancer, showing no treatment-related safety issues and progressing towards Phase 3 dose assessment.
  • Kintara emphasizes that the merger with TuHURA is crucial for continued operation and funding of the REM-001 study, urging stockholders to vote in favor.

Global Research Community Applies COVID-19 Lessons to Combat African Mpox Emergency

• The World Health Organization has declared mpox outbreak in Africa a Public Health Emergency of International Concern, prompting urgent calls for enhanced treatment accessibility and research efforts.
• Researchers are leveraging COVID-19 pandemic experiences, including adaptive trial designs, real-time data collection, and streamlined regulatory processes, to accelerate mpox vaccine development.
• While infrastructure and expertise from COVID-19 research could benefit mpox trials, challenges remain in financing, logistics, and healthcare access in affected African regions.

Suzetrigine: Hope or Hype for New Non-Opioid Pain Relief?

  • The FDA is considering suzetrigine, a non-opioid analgesic from Vertex Pharmaceuticals, for priority review, potentially marking a new class of pain medication in over two decades.
  • Suzetrigine received 'Fast Track' and 'Breakthrough Therapy' designations for moderate-to-severe acute pain, but is currently studied only for diabetic peripheral neuropathy.
  • While hailed as a potential solution to the opioid crisis, questions remain about suzetrigine's efficacy compared to existing treatments, leading to skepticism about its true impact.
  • The FDA's eagerness to approve non-opioid alternatives may be driving the fast-track designation, raising concerns whether the drug's benefits justify the accelerated approval process.

Hydroxychloroquine Shows Moderate COVID-19 Prevention in Large Clinical Trial

  • A large, double-blind, placebo-controlled trial (COPCOV) found a 15% reduction in symptomatic COVID-19 with hydroxychloroquine compared to placebo.
  • The study also demonstrated a significant reduction in all-cause respiratory illness and fewer workdays lost due to illness among those taking hydroxychloroquine.
  • Hydroxychloroquine was well-tolerated and safe in the study, which included over 4,600 participants across 11 countries from 2020 to 2022.
  • Researchers emphasize that current immunity from vaccines and natural infections has reduced COVID-19 severity, making hydroxychloroquine unnecessary for prevention today.

Tacrolimus Eye Drops with Cyclodextrins Show Improved Safety and Compliance in Ocular Inflammatory Pathologies

  • A new formulation of 0.015% tacrolimus eye drops with hydroxypropyl-beta-cyclodextrin (HPβCD) was compared to a 0.03% tacrolimus formulation with ethanol (TE).
  • The HPβCD formulation (TCD) demonstrated comparable effectiveness to TE, with significant improvements in patient-reported burning sensations and ocular pain.
  • Patient adherence increased significantly with TCD, likely due to the removal of ethanol, an irritant excipient, leading to better tolerability and reduced ocular surface toxicity.
  • The study suggests that TCD is a safer and more compliant alternative for managing ocular inflammatory pathologies, with potential for wider adoption in hospital pharmacy departments.

Survodutide Shows Promise in Obesity and MASH with Significant Weight and Blood Pressure Reduction

• Survodutide, a novel dual GCGR/GLP-1R agonist, demonstrates significant weight reduction in overweight or obese patients, with nearly 40% achieving over 20% body weight reduction after 46 weeks. • Phase II trial results indicate survodutide substantially reduces blood pressure in patients with metabolic dysfunction-associated steatohepatitis (MASH), showing promise in this area. • The dual mechanism of action of survodutide offers benefits in lowering body weight and promoting blood pressure reduction without causing muscle loss, according to study findings. • Adverse events leading to discontinuation were mainly due to rapid dose escalation, suggesting a more gradual approach could mitigate this issue and improve tolerability.

A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

NCT04667377CompletedPhase 2
Boehringer Ingelheim
Posted 3/8/2021

A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

NCT04771273CompletedPhase 2
Boehringer Ingelheim
Posted 4/27/2021

Nivolumab and Nab-Paclitaxel Show Promise in Muscle-Invasive Bladder Cancer

  • A phase II trial (NURE-Combo) evaluated neoadjuvant nivolumab plus nab-paclitaxel followed by adjuvant nivolumab in muscle-invasive bladder cancer patients ineligible for cisplatin.
  • The study met its primary endpoint, with 32.3% of patients achieving a pathologic complete response (ypT0N0) after neoadjuvant treatment and radical cystectomy.
  • The combination demonstrated a manageable safety profile, with grade 3/4 treatment-related adverse events occurring in 25.8% of patients.
  • These findings suggest a potential non-cisplatin-based chemoimmunotherapy approach for muscle-invasive bladder cancer, warranting further investigation.

Ultrasound Elastography Variability Defined for Liver Disease Clinical Trials

  • A recent study published in Radiology identifies variability in ultrasound elastography measurements of liver tissue, crucial for interpreting disease progression in clinical trials.
  • The study, part of the FNIH's NIMBLE project, evaluated SWE and VCTE ultrasound technologies in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
  • Researchers found that differences of less than 30.7% in SWE and 35.6% in VCTE measurements may reflect technical variability rather than actual changes in liver stiffness.
  • These findings will help clinicians avoid unnecessary changes in patient management and guide future studies validating ultrasound technology for clinical trials.

Rilertinib Demonstrates Superior Survival in EGFR-Mutated NSCLC in Phase 3 Trial

  • Phase 3 trial reveals rilertinib significantly improves overall survival in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
  • The study highlights rilertinib's potential as a novel treatment option for patients who have progressed on prior EGFR tyrosine kinase inhibitors.
  • Rilertinib showcases a manageable safety profile, offering a promising alternative with improved efficacy in advanced NSCLC.
  • These findings support rilertinib's role in addressing the unmet need for effective therapies in EGFR-mutated NSCLC, potentially changing treatment paradigms.

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