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Clinical Trial News

Jazz Pharmaceuticals' Epidyolex Fails Phase 3 Trial in Japan for Epilepsy

  • Jazz Pharmaceuticals' Epidyolex did not meet its primary endpoint in a Phase 3 trial in Japan for treatment-resistant epilepsies, despite showing numeric improvements.
  • The trial assessed Epidyolex as an adjunctive treatment for Dravet Syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex in pediatric patients.
  • British American Tobacco's cannabis investments are expected to drive growth, offsetting declines in traditional tobacco revenues through strategic investments like Organigram.
  • DanCann Pharma reported record revenue and its first positive EBITDA in Q2 2024, driven by increased product sales and strategic cost management.

Suvorexant Shows Promise in Reducing Hyperactive Delirium in Older Adults: A Randomized Clinical Trial

  • A clinical trial investigated suvorexant's efficacy in reducing delirium among older adults at high risk after hospitalization, a condition associated with increased morbidity and healthcare costs.
  • The study found a trend toward delirium reduction with suvorexant, though the overall difference was not statistically significant compared to placebo.
  • Post-hoc analysis revealed suvorexant may be more effective against hyperactive and mixed delirium subtypes, suggesting a potential benefit in managing agitation and impulsivity.
  • These findings indicate suvorexant could improve outcomes for older adults at risk of delirium, particularly those exhibiting hyperactive symptoms, potentially easing the burden on healthcare providers.

NeuRA Launches World's Largest Clinical Trial for Phantom Limb Pain

  • Neuroscience Research Australia (NeuRA) has initiated TITAN, a large-scale clinical trial, to evaluate potential treatments for phantom limb pain.
  • The trial will assess two drug-free interventions: a progressive rehabilitation program using mirror therapy and low-frequency non-invasive neuromodulation.
  • Phantom limb pain affects up to 80% of individuals post-amputation, causing severe symptoms and significantly impacting quality of life.
  • The Australia-wide trial, conducted online by physiotherapists, seeks participants experiencing phantom limb pain to join the study.

Melodi Health Initiates Pivotal Trial for Antibacterial Soft Tissue Support in Breast Reconstruction

  • Melodi Health has secured $10.75 million in Series A funding to advance clinical activities and product development for breast reconstruction.
  • The ARIA trial, a multicenter, randomized, controlled study, will evaluate the safety and efficacy of the Melodi Matrix in breast reconstruction.
  • The Melodi Matrix, designed to provide soft tissue support and controlled antibiotic release, aims to reduce post-surgical infections in breast cancer patients.
  • First patient enrolled in the ARIA trial at University of Utah Health, with the goal of addressing the unacceptable 10-14% infection rate in breast reconstruction.

MindBio's LSD Microdosing Trials Show Promise in Treating Depression

  • MindBio completed Phase 2a trials of MB22001 for Major Depressive Disorder, showing a 60% reduction in depressive symptoms among patients.
  • A significant 53% of MDD patients achieved remission by week 8, with an average decrease of 14.1 points on the MADRS scale.
  • Two Phase 2B clinical trials are underway, evaluating take-home microdosing of LSD (MB22001) for mental health conditions.
  • MindBio is also conducting a Phase 2B trial in women's health, marking a series of world-first government approvals for take-home LSD microdosing.

Ivonescimab and IBI363 Show Promise in Advanced Solid Tumors at ESMO 2024

• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer. • IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer. • Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC. • Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

NCT03228667RecruitingPhase 2
ImmunityBio, Inc.
Posted 12/11/2018

A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer

NCT04951635RecruitingPhase 3
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 3/18/2021

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

NCT05227664RecruitingPhase 2
Akeso
Posted 3/23/2022

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

NCT05061550RecruitingPhase 2
AstraZeneca
Posted 4/14/2022

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT05089734Active, Not RecruitingPhase 3
Gilead Sciences
Posted 11/17/2021

A Phase 3 Study of I-DXd in Subjects with Relapsed SCLC

2023-509628-16-00RecruitingPhase 3
Daiichi Sankyo Inc.
Posted 5/21/2024

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

NCT05382442RecruitingPhase 2
Akeso
Posted 6/27/2022

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

NCT03964727Active, Not RecruitingPhase 2
Gilead Sciences
Posted 10/15/2019

Neurocrine's NBI-1117568 Shows Promise in Phase II Schizophrenia Trial

  • Neurocrine Biosciences' NBI-1117568 met its primary endpoint, significantly reducing schizophrenia symptoms at a 20mg daily dose.
  • The Phase II trial demonstrated a statistically significant 7.5-point placebo-adjusted mean reduction in PANSS total score.
  • NBI-1117568 was generally well-tolerated, with no significant weight gain or extrapyramidal symptoms compared to placebo.
  • Neurocrine plans to advance NBI-1117568, a selective M4 agonist, into Phase III development early next year.

Gain Therapeutics' GT-02287 Shows Promise in Phase 1 Trial for Parkinson's Disease

  • Gain Therapeutics announced positive topline results from its Phase 1 clinical trial of GT-02287, a novel small molecule therapy targeting GCase for Parkinson's disease.
  • The study demonstrated that GT-02287 was safe and generally well-tolerated in healthy volunteers, with evidence of central nervous system (CNS) exposure and target engagement.
  • A Phase 1b trial in Parkinson's disease patients is planned for Q4 2024, with data expected by mid-2025 to assess safety, tolerability, and proof of mechanism.
  • GT-02287 is an orally administered, brain-penetrant molecule designed to restore GCase function, reduce α-synuclein aggregation, and improve motor and cognitive functions.

COVID-19 Booster Timing: Delaying Vaccination Offers No Immunological Advantage, Study Finds

• A study led by the Doherty Institute reveals that delaying COVID-19 booster vaccinations provides no immunological benefits in highly vaccinated populations. • The research showed that immediate booster administration elicits similar immune responses compared to delaying it by three months, with comparable increases in neutralizing antibodies. • Moderna's bivalent Spikevax booster effectively triggered an immune response against Omicron strains, although antibody levels waned significantly over time. • Experts recommend that eligible individuals receive their COVID-19 booster shots without delay to maintain optimal protection against severe illness, especially for high-risk groups.

Ubrelvy Shows Promise in Halting Migraines at Earliest Signs

  • A clinical trial reveals that ubrogepant (Ubrelvy) may effectively stop migraines when taken at the first signs of an attack.
  • Participants taking ubrogepant were 73% more likely to report no disability and normal function compared to those on a placebo.
  • 65% of patients taking ubrogepant reported minimal migraine symptoms 24 hours later, versus 48% in the placebo group.
  • The drug targets CGRP, a protein instrumental in migraine processes, offering a proactive approach to migraine management.

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