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Clinical Trial News

Withings' Sleep Rx Mat Receives FDA 510(k) Clearance for OSA Diagnosis Assistance

  • The FDA has granted 510(k) clearance to Withings' Sleep Rx Mat, a device designed to aid in the diagnosis of sleep apnea in adults.
  • The under-mattress mat tracks sleep, breathing, and cardiovascular activity, providing users with a sleep quality score and detailed sleep data.
  • The device uses pneumatic, sound, and motion sensors to monitor respiratory rate, heart rate, sleep cycles, snoring, and breathing disturbances.
  • Withings' VP, Antoine Robillard, highlights the potential for Sleep Rx to improve OSA diagnosis and reduce the economic burden of undiagnosed sleep apnea.

EORTC and Medidata Extend Partnership to Enhance Oncology Clinical Trials

  • The European Organisation for Research and Treatment of Cancer (EORTC) has extended its partnership with Medidata for four years.
  • The collaboration aims to improve patient access to oncology clinical trials and accelerate the delivery of new treatments.
  • EORTC is leveraging 13 Medidata solutions to streamline data management and enhance patient engagement in clinical trials.
  • The partnership will explore joint research and data collaboration with Medidata AI to improve cancer care standards.

Bria-IMT Shows Promise in Metastatic Breast Cancer, Including Brain Metastasis

  • Bria-IMT, combined with checkpoint inhibitors, demonstrates encouraging antitumor activity, including complete resolution of brain metastasis in a breast cancer patient.
  • Patients treated with Bria-IMT in phase 1/2 trials showed a median overall survival of 15.6 months, exceeding historical data for similar patient populations.
  • The Bria-IMT regimen is under evaluation in the pivotal phase 3 BRIA-ABC trial for advanced metastatic breast cancer, with interim results expected in the second half of 2025.

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

NCT06072612RecruitingPhase 3
BriaCell Therapeutics Corporation
Posted 12/5/2023

Combination Study of SV-BR-1-GM With Retifanlimab

NCT03328026Enrolling by InvitationPhase 1
BriaCell Therapeutics Corporation
Posted 3/16/2018

GLP-1 Receptor Agonists Spearhead Obesity Treatment Advancements

• Semaglutide (WEGOVY) marked the resurgence of GLP-1R agonists for obesity treatment, gaining FDA approval in June 2021 and achieving blockbuster status with $7.73 billion in sales by 2023. • Tirzepatide (ZEPBOUND), a GIPR/GLP-1R co-agonist, and setmelanotide (IMCIVREE), an MC4R agonist, have expanded the therapeutic landscape for obesity, addressing different mechanisms of action. • Obesity, a chronic disease affecting millions globally, heightens the risk of type 2 diabetes, heart disease, and certain cancers, emphasizing the need for safe and effective anti-obesity medications.

Tirzepatide (Mounjaro) Approved in Australia for Weight Management in Comorbid Adults

  • Australia's TGA has approved tirzepatide (Mounjaro) for chronic weight management in adults with obesity or overweight with comorbidities, alongside diet and exercise.
  • The approval expands Mounjaro's indication beyond type 2 diabetes, offering a new treatment option for eligible patients seeking weight loss and maintenance.
  • Supply of tirzepatide vials remains limited until August next year, but Eli Lilly Australia is transitioning to multi-use KwikPens to improve availability.
  • Experts emphasize that tirzepatide should be part of a multidisciplinary approach, including lifestyle advice and support from healthcare professionals.

Basking Biosciences Initiates Phase II Trial of BB-031 for Acute Ischemic Stroke

  • Basking Biosciences has dosed the first subject in its Phase II RAISE trial evaluating BB-031 for acute ischemic stroke (AIS).
  • The trial is a multicenter, randomized, placebo-controlled, double-blinded study assessing safety, tolerability, and preliminary efficacy of BB-031.
  • The study will enroll 156 patients within 24 hours of stroke onset and monitor them over 90 days for radiological outcomes.
  • BB-031, an RNA aptamer targeting von Willebrand Factor (vWF), aims to provide a rapid-onset, reversible thrombolytic option for stroke patients.

Incendia Therapeutics Initiates Phase Ic Trial of PRTH-101 for Advanced Solid Tumors

  • Incendia Therapeutics has dosed the first patient in a Phase Ic trial of PRTH-101, a novel DDR1 inhibitor, for advanced or metastatic solid tumors.
  • The open-label study will evaluate PRTH-101's safety, tolerability, and anti-tumor activity as a monotherapy and in combination with pembrolizumab.
  • The trial aims to enroll up to 270 patients in the US and will determine optimal dosing for future Phase II clinical programs.
  • The study will also investigate DDR1 and related proteins as potential biomarkers for patient response to PRTH-101 treatment.

China Streamlines Local Manufacturing for Foreign Pharmaceuticals

  • China is enhancing its regulatory framework to encourage local pharmaceutical manufacturing, particularly for drugs already approved as imports.
  • New regulations prioritize the review and approval of locally manufactured originator drugs, potentially shortening the approval timeline to 130 days.
  • Foreign companies can now transfer drug production to domestic Chinese entities, provided manufacturing processes remain consistent with original standards.
  • Challenges persist regarding intellectual property protection and regulatory compliance during technology transfer and local manufacturing.

Akebia Prepares Vafseo Launch for Dialysis Patients, Seeks Expansion to Pre-Dialysis Market

  • Akebia Therapeutics is set to launch Vafseo (vadadustat) in January 2025 for anemia treatment in dialysis patients, following its FDA approval in March.
  • The company plans to re-engage with the FDA to explore Vafseo's potential use in pre-dialysis chronic kidney disease (CKD) patients.
  • Akebia aims to present data from the Phase 3 PRO2TECT trial to support the drug's efficacy and safety in the pre-dialysis population, addressing an unmet medical need.
  • Company anticipates feedback from the FDA by the end of the year regarding further testing and approval pathways for the pre-dialysis market.

Fentanyl Vaccine Shows Promise in Preclinical Studies, Faces Hurdles in Addiction Treatment

  • A novel fentanyl vaccine has demonstrated promising results in rat models by blocking the drug's euphoric effects and reducing its impact on vital signs.
  • The vaccine works by stimulating the production of antibodies that prevent fentanyl from crossing the blood-brain barrier and activating mu opioid receptors.
  • Clinical trials for drug dependency vaccines have had limited success, highlighting the need for comprehensive treatment approaches that address underlying psycho-social issues.
  • Experts caution that a fentanyl vaccine is unlikely to be a standalone solution and should be integrated with psychotherapy and other support systems to tackle addiction effectively.

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