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Clinical Trial News

Synchron Advances Toward Pivotal Trial for Stentrode BCI After Promising Command Study Results

• Synchron is in discussions with the FDA regarding endpoints for a pivotal trial of its Stentrode brain-computer interface (BCI) implant, following positive results from the Command trial. • The Command trial demonstrated the safety of the Stentrode implant, with no serious adverse effects observed in six patients, paving the way for efficacy-focused pivotal studies. • Synchron's Stentrode BCI has shown potential in enabling patients to control digital devices, including Apple's Vision Pro and Amazon Alexa, using brain signals. • The company emphasizes the importance of simplicity and user-friendliness in BCI design, aiming to create technology accessible to patients who may not be technologically inclined.

Purdue Pharma Completes Phase 1 Study of Nalmefene for Opioid Overdose Reversal in Emergency Departments

  • Purdue Pharma has concluded the first phase of the COINED study, which investigates nalmefene hydrochloride injection's effectiveness in emergency departments for opioid overdose reversal.
  • The study assesses nalmefene's performance against naloxone, focusing on successful reversal rates, dosages, length of stay, and the incidence of precipitated withdrawal symptoms.
  • Nalmefene, a longer-acting opioid antagonist, is being examined for its impact on patient outcomes in the context of the evolving opioid crisis, with results expected later this year.
  • The COINED study, conducted at UC San Diego Health and El Centro Regional Medical Center, analyzes data from patients treated with nalmefene, with or without naloxone, versus naloxone alone.

Arbele Collaborates on AI Precision Oncology and Manufacturing for CDH17-Targeted Immunotherapeutics

  • Arbele partners with BioAI to develop an AI-based algorithm for quantifying CDH17 expression in colorectal cancer, aiming to improve patient selection for anti-CDH17 therapies.
  • A collaboration between Arbele and Chime Biologics will expedite the CMC process development of novel antibody-drug conjugates and T-cell engagers, supporting Arbele's pipeline.
  • The partnership with Chime Biologics aims to facilitate IND submissions for new molecular entities, including anti-CDH17 ADC (ARB102A), planned for early 2025.
  • Arbele's strategic collaborations seek to advance precision oncology and manufacturing capabilities, enhancing the development of targeted immunotherapeutics for advanced cancer patients.

Silmitasertib Trial Launched for Childhood Solid Tumors

  • A clinical trial is underway to assess silmitasertib combined with chemotherapy for treating solid tumors in children and young adults.
  • The trial aims to determine the recommended dose of silmitasertib and evaluate its safety, tolerability, and efficacy in cancer patients.
  • The study focuses on cancers like neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma, enrolling up to 114 participants.
  • Penn State College of Medicine, Beat Childhood Cancer Research Consortium, Four Diamonds, and Senhwa Biosciences are collaborating on this research effort.

Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors

NCT06541262RecruitingPhase 1
Milton S. Hershey Medical Center
Posted 10/30/2024

Rezdiffra Demonstrates Improved Quality of Life in NASH Patients with Fibrosis

• Madrigal Pharmaceuticals' Rezdiffra (resmetirom) shows significant improvements in emotional well-being and health distress in MASH/NASH patients. • The Phase 3 MAESTRO-NASH trial results, published in Hepatology, highlight Rezdiffra's positive impact on health-related quality of life (HRQL). • Patients treated with Rezdiffra experienced notable improvements in HRQL scores, particularly in the Worry, Health Distress, and Stigma domains. • The study underscores Rezdiffra's tolerability, with no worsening of HRQL related to potential side effects observed.

INmune Bio Completes Enrollment for Phase 2 Trial of XPro™ in Early Alzheimer's Disease

  • INmune Bio has concluded patient enrollment for its Phase 2 AD02 trial, targeting early Alzheimer's Disease (AD) patients with elevated neuroinflammation biomarkers.
  • The AD02 trial is a global, blinded, randomized study evaluating XPro™ (pegipanermin) in patients with mild cognitive impairment and mild AD.
  • The trial aims to enroll over 201 patients, with those currently in screening still eligible, potentially leading to a modest over-enrollment to enhance trial power.
  • XPro™, a selective inhibitor of soluble TNF, is being investigated for its potential to reduce neuroinflammation and improve cognitive function in AD patients.

Xolair Evaluated for Asthma Prevention in High-Risk Young Children

  • A clinical trial is evaluating whether omalizumab (Xolair) can prevent asthma development in young children with allergic conditions.
  • The study follows children who received Xolair or placebo for two years, assessing asthma incidence at ages 6 and 7.
  • Researchers are using molecular analyses to understand how early immune intervention affects the asthma march.
  • Biomarkers identified could help predict which children will respond to anti-IgE treatment, improving targeted therapy.

MediciNova's Ibudilast (MN-166) Shows Promise in ALS Treatment: Phase 2/3 Trial Update

  • MediciNova presented an update on its Phase 2/3 COMBAT-ALS trial of MN-166 (ibudilast) for amyotrophic lateral sclerosis (ALS) at the 2024 Annual NEALS Meeting.
  • The presentation highlighted the study design, scientific rationale, objectives, inclusion criteria, and enrollment status of the ongoing trial as of October 18, 2024.
  • An NIH-funded Expanded Access Protocol (EAP) is underway to provide MN-166 (ibudilast) to ALS patients ineligible for the COMBAT-ALS trial, supported by a $22 million grant.
  • MN-166 (ibudilast) is a small molecule compound targeting PDE4 and inflammatory cytokines, with potential benefits for neurodegenerative diseases like ALS.

ND0612 Shows Sustained Efficacy in Parkinson's Disease Motor Fluctuations

  • One-year outcomes from the BouNDless open-label extension study confirm the long-term efficacy of ND0612 in managing motor fluctuations in Parkinson's disease.
  • ND0612 demonstrated a sustained reduction in daily OFF time and an increase in ON time without troublesome dyskinesia over 12 months.
  • Patients treated with ND0612 reported significant improvements in quality of life compared to those on oral immediate-release levodopa/carbidopa.
  • ND0612 showed superior improvements in motor signs and experiences of daily living compared to oral immediate-release levodopa/carbidopa.

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

NCT04006210Active, Not RecruitingPhase 3
NeuroDerm Ltd.
Posted 9/30/2019

NanoViricides Advances NV-387 for Herpes Zoster Treatment to Phase II Trials

  • NanoViricides is set to begin Phase II trials for NV-387, an antiviral drug aimed at treating herpes zoster, commonly known as shingles.
  • NV-387 utilizes the company's proprietary nanoviricide platform to directly target and neutralize the varicella-zoster virus (VZV).
  • The Phase II trial will assess the drug's efficacy in reducing the duration and severity of shingles outbreaks, addressing a significant unmet medical need.
  • This advancement marks a crucial step in developing a novel therapeutic approach to combat VZV infections and improve patient outcomes.

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