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Clinical Trial News

Bayer Seeks FDA Approval to Expand Nubeqa's Indication for Metastatic Hormone-Sensitive Prostate Cancer

  • Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT).
  • The sNDA is seeking approval for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), expanding its current indications.
  • The submission is based on positive results from the Phase III ARANOTE trial, which were presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology.
  • Nubeqa, an oral androgen receptor inhibitor (ARi), is jointly developed by Bayer and Orion Corporation.

Mindfulness Meditation Offers Genuine Pain Relief, Independent of Placebo Effect, Study Shows

  • A new study using MRI scans reveals that mindfulness meditation reduces pain through mechanisms distinct from the placebo effect, offering genuine pain relief.
  • Researchers at UC San Diego found that mindfulness meditation significantly lowered pain intensity and emotional response to pain compared to placebo and control groups.
  • The study identified specific brain signatures associated with pain reduction through meditation, suggesting its potential as a direct intervention for chronic pain management.
  • Unlike placebo creams, mindfulness meditation showed no significant impact on the brain signature related to psychosocial factors and expectations of pain.

FINE-REAL Study Shows Finerenone Use in Real-World Settings Aligns with Clinical Trial Data for CKD and T2D

  • Interim results from the FINE-REAL study indicate that finerenone is being initiated in routine clinical practice across various settings for patients with CKD and T2D.
  • The study found that treatment discontinuation rates were low, and the occurrence of hyperkalemia was consistent with observations from clinical trials.
  • A significant proportion of patients in the study were screened for CKD using UACR measurements, aligning with guideline recommendations for early detection.
  • The real-world data suggests that physicians are increasingly treating patients with earlier stages of CKD compared to those enrolled in randomized clinical trials.

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

NCT01807221CompletedPhase 2
Bayer
Posted 6/17/2013

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

NCT02540993CompletedPhase 3
Bayer
Posted 9/17/2015

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

NCT02545049CompletedPhase 3
Bayer
Posted 9/17/2015

Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease

NCT03071263CompletedPhase 2
Relypsa, Inc.
Posted 1/23/2017

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

NCT05348733Recruiting
Bayer
Posted 6/13/2022

Prior Local Therapy Does Not Compromise ARPI Treatment in mCRPC

  • A meta-analysis of the COU-AA-302 and ACIS trials indicates that prior local therapy does not significantly impact the effectiveness of first-line androgen receptor pathway inhibitors (ARPIs) in metastatic castrate-resistant prostate cancer (mCRPC).
  • The study found no significant association between prior local therapy modalities and an increased risk of radiographic progression or death in mCRPC patients treated with ARPIs.
  • These findings may increase oncologist confidence in prescribing targeted therapies for mCRPC, regardless of a patient's prior local therapy exposure, such as radiotherapy or radical prostatectomy.
  • The analysis included data from over 2000 patients, showing consistent outcomes across different treatment arms and local therapy types.

Optimal Lymphodepletion Improves Outcomes with Equecabtagene Autoleucel in Multiple Myeloma

  • A post-hoc analysis of the FUMANBA-1 study reveals that standard lymphodepletion prior to Equecabtagene Autoleucel infusion enhances remission depth and duration in R/R MM patients.
  • The standard-dose lymphodepletion group showed a significantly higher 12-month MRD negativity rate (90.4%) compared to the dose-adjusted group (63.7%), with HR=3.33 (P=0.0166).
  • Progression-free survival at 12 months was also superior in the standard-dose group (92.2%) versus the dose-adjusted group (73.5%), with HR=3.64 (P=0.0032).
  • No significant differences in the incidence or severity of CRS and ICANS were observed between the standard and dose-adjusted lymphodepletion groups.

Obinutuzumab Shows Positive Results in Phase 3 Trial for Lupus Nephritis

  • Genentech's phase 3 REGENCY trial of obinutuzumab (Gazyva) plus standard therapy met its primary endpoint, demonstrating a statistically significant complete renal response in patients with lupus nephritis.
  • The study results support the potential of obinutuzumab as a valuable treatment option for lupus nephritis, addressing an unmet need in managing this severe manifestation of systemic lupus erythematosus.
  • Genentech plans to submit the REGENCY trial data for publication and presentation at an upcoming scientific conference, further disseminating the findings to the medical community.

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

NCT04221477Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 8/10/2020

Lumos Pharma's LUM-201 Shows Promise in Pediatric Growth Hormone Deficiency Trials

  • Lumos Pharma's LUM-201 met all primary and secondary endpoints in Phase 2 clinical trials, indicating its potential in treating pediatric growth hormone deficiency.
  • The oral growth hormone secretagogue, LUM-201, uniquely stimulates growth hormone release with a pulsatile mechanism, demonstrating durable results up to 24 months.
  • Analysts are optimistic about Lumos Pharma's financial stability, with sufficient funds to support operations into Q1 2025 and potential Phase 3 trials.

Avicenna.AI's CINA-CSpine AI Tool Receives FDA 510(k) Clearance for Cervical Spine Fracture Detection

• Avicenna.AI has received FDA 510(k) clearance for its CINA-CSpine tool, designed to detect and assess cervical spine fractures using AI. • The CINA-CSpine tool utilizes deep learning and machine learning algorithms to analyze CT imaging for cervical spine fractures. • The AI tool aims to reduce the time between scan and interpretation, which is crucial for the effective treatment of cervical spine fractures.

Vutrisiran Shows Promise in ATTR-CM Treatment: Alnylam's HELIOS-B Data Highlights Cardiac Benefits

  • New data from the HELIOS-B study reveals vutrisiran significantly improves cardiac structure and function in ATTR-CM patients over 30 months compared to placebo.
  • Vutrisiran demonstrates stability in cardiac biomarkers NT-proBNP and Troponin-I, indicating a potential disease-modifying effect, particularly when administered early.
  • Alnylam has submitted regulatory applications to the FDA and EMA for vutrisiran, aiming to establish it as a first-line therapy for ATTR amyloidosis with cardiomyopathy.
  • The HELIOS-B trial's results, published in NEJM, underscore vutrisiran's potential to reduce mortality and cardiovascular events in ATTR-CM patients.

MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

NCT06128629RecruitingPhase 3
Intellia Therapeutics
Posted 12/13/2023

CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

NCT04136171Active, Not RecruitingPhase 3
Ionis Pharmaceuticals, Inc.
Posted 3/13/2020

HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

NCT04153149Active, Not RecruitingPhase 3
Alnylam Pharmaceuticals
Posted 11/26/2019

APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

NCT01960348CompletedPhase 3
Alnylam Pharmaceuticals
Posted 11/1/2013

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

NCT03759379Active, Not RecruitingPhase 3
Alnylam Pharmaceuticals
Posted 2/14/2019

Gene and Cell Therapies Show Promise in Treating Various Cardiac Diseases

  • Rocket Pharmaceuticals completed enrollment in a Phase 2 trial of RP-A501 gene therapy for Danon disease, targeting LAMP2 expression and left ventricular mass reduction.
  • LX2006 gene therapy from Lexeo Therapeutics demonstrated improved biomarkers in patients with Friedreich Ataxia cardiomyopathy in early-stage trials.
  • Immix Biopharma dosed the first patient in a Phase 1b/2 trial of NXC-201 CAR-T therapy for relapsed/refractory light chain amyloidosis.
  • Verve Therapeutics dosed the first patient in a Phase 1b trial of VERVE-102, an in vivo base editing therapy targeting PCSK9 for heterozygous familial hypercholesterolemia.

Gene Therapy for Cardiomyopathy Associated With Friedreich's Ataxia

NCT05445323Active, Not RecruitingPhase 1
Lexeo Therapeutics
Posted 8/24/2022

A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease

NCT06092034RecruitingPhase 2
Rocket Pharmaceuticals Inc.
Posted 9/5/2023

Study of NXC-201 CAR-T in Patients with Light Chain (AL) Amyloidosis

NCT06097832RecruitingPhase 1
Nexcella Inc.
Posted 6/5/2024

Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia

NCT05302271RecruitingPhase 1
Weill Medical College of Cornell University
Posted 2/22/2022

Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction

NCT06061549RecruitingPhase 1
Sardocor Corp.
Posted 8/24/2023

A Study of VERVE-102 in Patients with Familial Hypercholesterolemia or Premature Coronary Artery Disease

NCT06164730RecruitingPhase 1
Verve Therapeutics, Inc.
Posted 4/30/2024

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