MedPath

Clinical Trial News

Nordic Clinical Trials Conference to Address Key Industry Challenges and Innovation in Copenhagen

  • The 12th Annual Outsourcing in Clinical Trials & Clinical Trial Supply Nordics meeting in Copenhagen will bring together experts to explore current trends in trial operations, outsourcing, and supply chain management.
  • The conference features parallel streams focusing on outsourcing, clinical trial supply, and technology innovation, with special emphasis on EU regulations, patient-centricity, and advanced technologies.
  • Key discussions will cover decentralized clinical trials, sustainability initiatives, AI implementation in clinical development, and strategies for strengthening sponsor-CRO partnerships.

SJPedPanel: A Targeted Gene Panel for Enhanced Detection of Driver Alterations in Childhood Cancers

  • SJPedPanel, a pan-cancer gene panel, demonstrates high accuracy in detecting driver alterations across various childhood malignancies.
  • The panel covers 91% of reported driver alterations, including SNVs, indels, SVs, ITDs, and CNV/LOH, identified through comprehensive genomic sequencing.
  • SJPedPanel shows superior performance compared to whole-exome sequencing (WES) for childhood cancers, with a smaller panel size.
  • The targeted approach balances panel size and effective coverage, successfully detecting fusions and ITDs, while also highlighting challenges in detecting certain structural variants.

Nanoscope Therapeutics to Advance MCO-010 for Stargardt Disease to Phase 3 Trial Following FDA Meeting

  • Nanoscope Therapeutics' MCO-010 gene therapy is set to advance to a Phase 3 registrational trial for Stargardt Macular Degeneration after a productive meeting with the FDA.
  • The FDA has provided input on the Phase 3 trial design, which will assess MCO-010's safety and efficacy using best-corrected visual acuity as the primary endpoint.
  • The planned Phase 3 trial will enroll legally blind patients as young as 12 years old, expanding the population from the Phase 2 study, and will be the first randomized, controlled gene therapy trial for Stargardt disease.
  • The FDA has agreed that the current nonclinical data package is sufficient to support a future Biologics License Application (BLA) submission for MCO-010.

Efficacy and Safety of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]

NCT04945772CompletedPhase 2
Nanoscope Therapeutics Inc.
Posted 7/13/2021

Safety and Effects of a Single Intravitreal Injection of vMCO-010 Optogenetic Therapy in Subjects With Stargardt Disease

NCT05417126CompletedPhase 2
Nanoscope Therapeutics Inc.
Posted 7/5/2022

Nxera and Cancer Research UK Presenting Phase 1/2a Trial of EP4 Antagonist HTL0039732 at ESMO 2024

  • Nxera Pharma and Cancer Research UK are presenting the Phase 1/2a trial of HTL0039732, an oral EP4 antagonist, at ESMO 2024, highlighting its potential in treating advanced solid tumors.
  • The trial evaluates HTL0039732's safety, tolerability, and anti-tumor activity as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors.
  • HTL0039732 blocks the PGE2-EP4 pathway, enhancing the immune system's ability to detect and control cancer cells, potentially benefiting patients resistant to current immunotherapies.
  • Recruitment for the trial, sponsored by Cancer Research UK, is ongoing across multiple UK hospitals, with initial dosing in August 2023, marking progress in novel cancer immunotherapy.

HTL0039732 in Participants With Advanced Solid Tumours

NCT05944237RecruitingPhase 1
Cancer Research UK
Posted 7/13/2023

Keymed's Stapokibart Receives Approval in China for Atopic Dermatitis

  • Keymed Biosciences' Stapokibart (Kangyueda) has been approved by China's NMPA for treating moderate-to-severe atopic dermatitis in adults.
  • The approval was based on a Phase III trial where Stapokibart demonstrated significant improvements in EASI-75 and IGA scores at week 16.
  • Long-term treatment with Stapokibart showed sustained clinical benefits and a favorable safety profile over 52 weeks.
  • Stapokibart is the first domestically manufactured IL-4Rα antibody drug approved in China, blocking both IL-4 and IL-13 signaling.

NKGen Biotech's Troculeucel Shows Promise in Early Alzheimer's Trial, Advances to Phase 2

  • NKGen Biotech's troculeucel, an autologous NK cell therapy, demonstrated cognitive improvement in moderate Alzheimer's patients in a Phase 1 trial.
  • Two of three patients treated with the highest dose of troculeucel showed improvement on the CDR-SB scale, moving from moderate to mild Alzheimer's.
  • The Phase 2 trial, a randomized, double-blind, placebo-controlled study, has dosed its first patient and will evaluate troculeucel in a larger cohort.
  • Troculeucel is being developed for neurodegenerative disorders and cancers, representing a potential new treatment option for Alzheimer's disease.

Moberg Pharma's MOB-015 Phase 3 Trial Faces Uncertainty After Subgroup Analysis

  • Moberg Pharma reports lower than expected clinical cure rates in a subset of patients from its ongoing North American Phase 3 trial of MOB-015 for onychomycosis.
  • The Phase 3 study, conducted across 33 centers in the US and Canada with 384 patients, is crucial for potential US registration and commercialization of MOB-015.
  • The company emphasizes data integrity and awaits topline results before speculating on the future potential of MOB-015, a topical terbinafine formulation.
  • Moberg Pharma will host a conference call to discuss the implications of these findings with its CEO, CMO, and CSO.

World Sepsis Day Highlights Critical Need for Better Trial Design and Targeted Therapeutics

  • Sepsis claims 11 million lives globally each year, with over 7,000 facilities participating in World Sepsis Day to raise awareness and promote medical education.
  • Current sepsis treatments focus on antibiotics and supportive care, but there remains a critical lack of drugs targeting underlying pathophysiological processes.
  • Recent Phase III trial failures, including AM Pharma's reCAP and Asahi Kasei's thrombomodulin alfa, highlight the need for improved trial design and AI-driven patient stratification.

International Research Team Proposes Multimodal Treatment Strategy for Long COVID and Post-Acute Infectious Syndromes

  • An international research team has developed a comprehensive treatment approach combining pharmacological and physical therapies for post-acute infectious syndromes, including long COVID.
  • Metformin and low-dose naltrexone showed promising results in treating long COVID symptoms, with metformin demonstrating reduced diagnosis rates in a double-blind trial.
  • The multimodal strategy includes physical interventions like extracorporeal apheresis, which improved symptoms in 70% of long COVID patients in clinical studies.

Hong Kong Approves Two New Drugs for Hypercalcemia Under "1+" Mechanism

  • Hong Kong approves two new oral drugs for treating hypercalcemia in patients with parathyroid carcinoma and primary hyperparathyroidism under the "1+" mechanism.
  • The "1+" mechanism, implemented since November 2023, expedites the registration of drugs for life-threatening or severely debilitating diseases.
  • These drugs, already approved in Japan, met Hong Kong's safety, efficacy, and quality standards after local expert review of clinical data.
  • Since implementing the "1+" mechanism, the Department of Health has received over 250 enquiries involving more than 70 pharmaceutical companies.

Trending News

1

Lundbeck's Eptinezumab Shows Strong Efficacy in Asian Chronic Migraine Patients in Phase III SUNRISE Trial

2 days ago
2

Lilly's Once-Weekly Insulin Efsitora Alfa Achieves Non-Inferiority in Phase 3 Trials, Reducing Injection Burden by 300 Doses Annually

a day ago
3

Japanese Startup's Urine-Based Cancer Test Detects Stage 0 Lung Cancer in Hokkaido Pilot Study

2 days ago
4

GH Research Submits IND Hold Response to FDA for Depression Treatment GH001 Ahead of Schedule

3 days ago
5

Otsuka Pharmaceutical Secures Global Rights to HBM7020 BCMAxCD3 Bispecific T-Cell Engager for Autoimmune Diseases

15 hours ago
6

CanSinoBIO Launches iPneucia® 13-Valent Pneumococcal Vaccine Optimized for Chinese Children

3 days ago
7

Novo Nordisk's Mim8 Shows Safe Direct Switch from Emicizumab in Phase 3b Hemophilia A Trial

a day ago
8

EMA Recommends Approval of Alvotech's Biosimilar to Eylea for Eye Disorders

7 hours ago
9

Roche's NXT007 Achieves Zero Bleeds in Phase I/II Hemophilia A Trial, Advances to Phase III

11 hours ago
10

GLP-1 Diabetes Drug Liraglutide Reduces Migraine Days by Half in Pilot Study

3 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy