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Clinical Trial News

CHMP Recommends Mirvetuximab Soravtansine for FRα+ Platinum-Resistant Ovarian Cancer

  • The CHMP has recommended marketing authorization for mirvetuximab soravtansine for adult patients with FRα+ platinum-resistant ovarian cancer.
  • The recommendation is based on the phase 3 MIRASOL trial, which showed improved progression-free survival compared to chemotherapy.
  • In the MIRASOL trial, mirvetuximab soravtansine demonstrated a median PFS of 5.6 months vs 4.0 months with chemotherapy.
  • The European Commission is expected to make a final decision on mirvetuximab soravtansine later in 2024, potentially expanding treatment options.

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

NCT04209855CompletedPhase 3
AbbVie
Posted 12/31/2019

Sonic Incytes' Velacur VDFF Receives FDA 510(k) Clearance for Enhanced Liver Fat Assessment

  • Sonic Incytes' Velacur Determined Fat Fraction (VDFF) receives FDA 510(k) clearance, integrating quantitative ultrasound measures for liver fat assessment.
  • VDFF demonstrates a strong correlation (0.85) with MRI-PDFF, the gold standard, and 95% accuracy in classifying hepatic steatosis.
  • The new tool offers similar clinical utility to MRI-PDFF at the point of care, which transforms the management of hepatic steatosis (fatty liver disease).
  • VDFF's approval arrives as MASLD and MASH affect millions, offering a timely, non-invasive diagnostic solution alongside new MASH therapeutics.

Oneness Biotech's SNS812 Demonstrates Superior Efficacy Against COVID-19 Variants in Phase 2 Trial

  • Oneness Biotech and Microbio (Shanghai)'s SNS812 achieved statistically significant and clinically meaningful endpoints in a Phase 2 trial for COVID-19 treatment.
  • SNS812 demonstrated efficacy against prevalent COVID-19 variants, including JN.1, KP1-4, LB.1, BA.2, and XBB, with a good safety profile and no drug-related adverse events.
  • The trial showed SNS812 significantly reduced the time to viral negativity (median 2.9 days in the 200mg group) and improved symptoms like loss of smell and taste compared to placebo.
  • SNS812 presents a potential breakthrough solution for treating COVID-19, addressing the urgent need for therapies effective against emerging variants.

Vasa Therapeutics' VS-041 Enters Clinical Trials for HFpEF Treatment

  • Vasa Therapeutics' lead drug candidate, VS-041, has entered Phase I clinical trials to evaluate its potential as a treatment for heart failure with preserved ejection fraction (HFpEF).
  • The trial leverages Quotient Sciences' Translational Pharmaceutics platform for rapid drug manufacturing and clinical program execution, aiming for efficient data acquisition.
  • VS-041 is being developed as a personalized medicine-based treatment for HFpEF, a condition affecting millions globally and characterized by a stiffened heart.
  • The Phase I trial will assess the safety, tolerability, and initial efficacy insights of VS-041 in healthy volunteers, marking a significant step in its development.

Insights from Failed IPF Trials Highlight Need for Adaptive Designs and Patient-Focused Outcomes

  • Analysis of recent idiopathic pulmonary fibrosis (IPF) trial failures emphasizes the importance of learning from setbacks to refine future clinical trial designs.
  • Small sample sizes and short study durations in phase 2 trials can lead to overestimations of efficacy that do not translate to phase 3 studies.
  • Adaptive trial designs, rigorous statistical methods, and a focus on patient-relevant outcomes are crucial for improving IPF trial success.
  • Concurrent therapies in phase 3 trials that were not present in phase 2 can confound results.

DM Clinical Research Expands Network with New Shreveport Site Focused on Neurology, Pain, and Sleep

  • DM Clinical Research partners with Brain and Pain Care and Sleep Care Clinic in Shreveport, LA, to establish a new clinical trial site.
  • The embedded site will focus on neurology, pain management, and sleep disorders, leveraging the expertise of Drs. Jai Munjampalli and Sara Samreena.
  • This collaboration aims to enhance patient access to innovative treatments and clinical trials in the Shreveport region.
  • The expansion strengthens DM Clinical Research's national network, supporting diverse and inclusive clinical research opportunities.

Taletrectinib Demonstrates Efficacy in ROS1-Positive NSCLC, Regardless of Prior TKI Exposure

  • Taletrectinib shows promising overall and intracranial response rates in ROS1-positive NSCLC patients, irrespective of prior TKI treatment.
  • The TRUST-II trial reveals consistent efficacy and safety profiles for taletrectinib in both TKI-naive and TKI-pretreated patients.
  • Common adverse effects of taletrectinib include increased liver enzyme levels and gastrointestinal issues, with most being low grade.
  • The global TRUST-II study reinforces findings from the regional TRUST-I trial, supporting taletrectinib as a potential treatment option.

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

NCT04919811RecruitingPhase 2
Nuvation Bio Inc.
Posted 9/1/2021

A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

NCT04395677Active, Not RecruitingPhase 2
AnHeart Therapeutics Inc.
Posted 7/7/2020

Atamyo Therapeutics Advances Gene Therapy Programs for Limb-Girdle Muscular Dystrophy

  • Atamyo Therapeutics completed recruitment for the dose escalation phase of the Phase 1b trial of ATA-100 for LGMD2I/R9.
  • The company submitted an IND application to the FDA for ATA-200, a gene therapy for LGMD2C/R5, expanding its clinical trial to the U.S.
  • Initial results from the ATA-100 trial show promising functional improvements and a marked decline in creatine kinase levels in treated patients.
  • The FDA granted rare pediatric disease designation to ATA-200, highlighting the unmet need for treatments for these rare muscular dystrophies.

ATA-200 Dose-escalation Gene Therapy Trial in Patients With LGMDR5

NCT05973630RecruitingPhase 1
Atamyo Therapeutics
Posted 2/15/2025

GNT0006 Gene Therapy Trial in Patients With LGMDR9

NCT05224505RecruitingPhase 1
Atamyo Therapeutics
Posted 8/10/2022

Prilenia's Pridopidine for Huntington's Disease: Hope vs. Hype in Clinical Trials

  • Pridopidine has undergone multiple clinical trials for Huntington's disease (HD), with all major endpoints consistently failing to be met, raising concerns about its efficacy.
  • Recent interpretations of the PROOF-HD trial results by Prilenia Therapeutics have been controversial, emphasizing subgroup benefits while downplaying overall negative outcomes.
  • The EMA has accepted Prilenia's application for marketing authorization review, but this step is routine and doesn't guarantee approval, warranting caution against undue hype.
  • Concerns arise regarding potential influence on treatment decisions, particularly regarding neuroleptic use, urging transparent and balanced reporting of clinical trial results.

The Impact of Chloro and Methoxy Groups on Small Molecule Drug Discovery

  • Chloro and methoxy substituents can significantly enhance intermolecular interactions in drug candidates, offering unique advantages in drug discovery.
  • Recent clinical readouts highlight the importance of small molecules targeting BTK for multiple sclerosis and Axl, TYRO3, and Mer for oncology.
  • Functional groups like chloro and methoxy play a crucial role in modulating drug efficacy and safety profiles, influencing target binding and pharmacokinetic properties.

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