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Drug Safety Experts Call for Enhanced Diagnostic Accuracy in Clinical Trials to Protect Patient Safety

  • An estimated 12 million U.S. adults experience outpatient diagnostic errors annually, with cancer representing 37.8% of the highest-severity misdiagnosis harms, significantly impacting clinical trial participation.
  • City of Hope's centralized review system revealed safety concerns in nearly half of examined oncology trials, with Phase I studies and investigator-initiated trials showing the highest risk for patient safety issues.
  • Drug Safety/Pharmacovigilance professionals play a crucial role in safeguarding trial participants through proactive monitoring, detailed safety management plans, and comprehensive adverse event documentation.

Nerandomilast Shows Promise in Phase 3 Trial for Idiopathic Pulmonary Fibrosis

  • Boehringer Ingelheim's nerandomilast met its primary endpoint in the Phase 3 FIBRONEER-IPF trial, demonstrating improved lung function in IPF patients.
  • The trial is the first in a decade to meet its primary endpoint, offering hope for a new treatment option for this progressive disease.
  • Nerandomilast, a phosphodiesterase 4B inhibitor, aims to reduce inflammation and fibrosis in the lungs, addressing a high unmet need.
  • Full data will be presented in the first half of 2025, with plans for regulatory submissions to the FDA and other agencies.

A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT04419506CompletedPhase 2
Boehringer Ingelheim
Posted 7/28/2020

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321069CompletedPhase 3
Boehringer Ingelheim
Posted 10/6/2022

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

NCT05321082CompletedPhase 3
Boehringer Ingelheim
Posted 11/16/2022

Theramex Launches Linzagolix (Yselty) for Uterine Fibroids in Europe

  • Theramex has launched Yselty (linzagolix), a GnRH receptor antagonist developed by Kissei, in Germany for treating moderate to severe uterine fibroids.
  • Yselty is approved in Europe and the UK for adult women of reproductive age, offering a new option for those who cannot take hormonal agents.
  • Clinical trials confirmed Yselty's efficacy both with and without add-back therapy, improving bleeding and pain symptoms associated with uterine fibroids.
  • Kissei has out-licensed linzagolix development to multiple companies, with ongoing Phase III trials in Japan for uterine fibroids and Phase II trials for endometriosis.

STRIDE Regimen Demonstrates Doubled 5-Year Survival in Unresectable Hepatocellular Carcinoma

  • The STRIDE regimen (durvalumab plus tremelimumab) shows a significant 5-year survival benefit in patients with unresectable hepatocellular carcinoma (uHCC).
  • The HIMALAYA trial's 5-year analysis revealed a 19.6% survival rate with STRIDE compared to 9.4% with sorafenib, marking a 24% reduction in mortality risk.
  • Patients achieving disease control with STRIDE experienced more than double the survival time compared to those on sorafenib (28.7% vs. 12.7% at 5 years).
  • The safety profile of STRIDE remained consistent with previous analyses, with no new safety concerns identified during the extended follow-up period.

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

NCT03298451Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/11/2017

FDA Approves New Manufacturing Line for Sanofi and AstraZeneca's Beyfortus, Boosting RSV Protection for Infants

  • The FDA has approved a new manufacturing line for Sanofi and AstraZeneca's Beyfortus, an RSV antibody, to increase U.S. supply for the upcoming season.
  • Beyfortus is a long-acting monoclonal antibody that provides passive immunity against RSV in newborns and infants by blocking viral entry into host cells.
  • Clinical data shows Beyfortus has high real-world effectiveness, consistently exceeding 80% in preventing RSV disease and hospitalizations in infants.
  • Sanofi has begun shipping Beyfortus doses to healthcare providers and the CDC, ensuring wider availability for both in-season and off-season immunization.

Metformin Slows Aging in Monkeys, Offering Hope for Human Healthspan

  • A study in elderly male monkeys showed that metformin, a common diabetes drug, slowed down several aging processes, including cognitive decline and inflammation.
  • The monkeys treated with metformin exhibited improved learning and memory, reduced brain shrinkage, and a restoration of youthful neuronal profiles.
  • Metformin's benefits extended beyond the brain, rescuing kidneys, lungs, and muscles from age-related issues and reverting gene expression to more youthful states.
  • The findings support further investigation into metformin as a potential intervention to extend human healthspan and combat age-related diseases.

Pilot Study on Evaluating the Geroprotective Effect of Metformin

NCT06459310RecruitingPhase 2
Xuanwu Hospital, Beijing
Posted 6/30/2024

ARANOTE Trial: Darolutamide Plus ADT Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer

  • The ARANOTE trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide-treated patients experienced a 46% reduction in the risk of radiographic progression or death compared to those receiving ADT plus placebo, with consistent benefits across subgroups.
  • The combination therapy also delayed time to castration-resistant prostate cancer and pain progression, while showing a favorable safety profile with lower rates of fatigue.
  • These findings suggest darolutamide plus ADT could become a new standard of care for mHSPC, offering an alternative to chemotherapy-based regimens.

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

NCT04136353Active, Not RecruitingPhase 3
University of Sydney
Posted 3/31/2020

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

NCT04736199Active, Not RecruitingPhase 3
Bayer
Posted 2/23/2021

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

NCT05794906RecruitingPhase 3
Bayer
Posted 4/3/2023

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

NCT02799602CompletedPhase 3
Bayer
Posted 11/30/2016

Apabetalone Shows Promise as Epigenetic Therapy for Chronic Diseases

  • Qatar University researchers highlight Apabetalone's potential as an epigenetic therapy for treating various chronic diseases by targeting gene expression.
  • Apabetalone, a unique inhibitor with FDA breakthrough therapy designation (excluding oncology), impacts multiple biological functions involved in disease development.
  • Preclinical studies suggest Apabetalone's efficacy in cardiovascular, renal, neurological, viral, and cancer disorders, warranting further investigation in clinical trials.
  • The research underscores the importance of epigenetic treatments in regulating gene transcription and improving cell communication for enhanced health outcomes.

VasoRx's Lipid Nanoparticle Drug Delivery System Targets TGFβ-Related Diseases

  • VasoRx, a Yale-backed startup, is developing a lipid nanoparticle drug delivery system for targeted drug delivery, potentially reducing toxicity and side effects.
  • The technology focuses on diseases correlated with the transforming growth factor beta (TGFβ) superfamily, including cardiovascular diseases and inherited disorders.
  • Preclinical studies suggest the platform can improve drug delivery, and the company aims to begin human clinical trials soon to validate its efficacy and safety.
  • The novel drug delivery system could offer a safer, more effective way to treat diseases like atherosclerosis, aneurysms, and pulmonary hypertension.

Inavolisib Shows Promise in PIK3CA-Mutated Advanced Solid Tumors

  • Phase 2 CRAFT trial data reveals inavolisib demonstrates a manageable safety profile and promising disease control in patients with refractory, advanced solid tumors harboring PIK3CA mutations.
  • The study showed a disease control rate of 60% at week 8 and 32% at week 16 in efficacy-evaluable patients, with a median follow-up of 11.2 months.
  • Common adverse effects included hyperglycemia and diarrhea, predominantly grade 1 or 2, suggesting inavolisib's tolerability in this patient population.
  • Further research is underway to identify potential response predictors and resistance mechanisms to inavolisib in PIK3CA-mutated cancers.

CRAFT: The NCT-PMO-1602 Phase II Trial

NCT04551521CompletedPhase 2
German Cancer Research Center
Posted 10/13/2021

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