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Clinical Trial News

Ozempic and Mounjaro Show Promise in Managing Type 1 Diabetes

  • Ozempic (semaglutide) and Mounjaro (tirzepatide) demonstrate potential benefits in managing type 1 diabetes by aiding in weight loss and blood sugar control.
  • Mounjaro users experienced an 18% reduction in daily insulin dosage, indicating improved insulin resistance, according to study findings.
  • Clinical trial data reveals significant weight loss among type 1 diabetics, with 77% of Ozempic users and 93% of Mounjaro users losing at least 5% of body weight.
  • Experts emphasize the need for larger, prospective trials to fully assess the safety and efficacy of these drugs in type 1 diabetes patients with overweight or obesity.

Clarity Pharmaceuticals' 67Cu-SAR-bisPSMA Shows Promise in mCRPC Trial

  • Clarity Pharmaceuticals' SECuRE trial demonstrates a favorable safety profile for 67Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer (mCRPC).
  • Early data from the multi-dose cohort shows significant PSA declines, with one patient achieving a 92.3% reduction after prior therapy failure.
  • The Safety Review Committee approved continuation to the dose expansion phase based on positive safety and efficacy observations.
  • The trial's success may lead to earlier-stage prostate cancer treatment studies with 67Cu-SAR-bisPSMA.

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604RecruitingPhase 1
Clarity Pharmaceuticals Ltd
Posted 8/11/2021

WHO Prequalifies First Mpox Vaccine to Combat Outbreak in Africa

  • The World Health Organization (WHO) has prequalified the MVA-BN vaccine, manufactured by Bavarian Nordic, as the first vaccine against mpox.
  • This prequalification is expected to facilitate increased access to the vaccine in communities with urgent needs, particularly in Africa, to reduce transmission.
  • The MVA-BN vaccine can be administered in two doses to individuals 18 years and older, with an estimated 82% effectiveness, or a single dose with 76% effectiveness.
  • WHO's prequalification will help accelerate procurement by governments and international agencies like Gavi and UNICEF, and fast-track regulatory approvals worldwide.

FDA Approves Roche's Injectable Ocrevus for Multiple Sclerosis

  • The FDA has approved Roche's subcutaneous injectable version of Ocrevus for treating multiple sclerosis, offering a quicker 7-minute administration time.
  • The approval was based on the OCARINA II trial, demonstrating non-inferiority to the intravenous formulation regarding drug levels and similar safety profiles.
  • The injectable Ocrevus, to be available starting in October, expands treatment access by allowing administration in neurologist offices, avoiding specialized infusion centers.
  • Ocrevus targets CD20-positive B cells, key contributors to nerve cell damage, and has treated over 350,000 MS patients globally with the IV formulation.

Antibody-Drug Conjugates Linked to Peripheral Neuropathy: A Real-World Pharmacovigilance Study

  • A comprehensive analysis of the FAERS database reveals a significant association between antibody-drug conjugates (ADCs) with tubulin-binding payloads and peripheral neuropathy (PN).
  • Enfortumab vedotin exhibits a particularly strong association with PN compared to other ADCs, highlighting the need for careful monitoring in patients receiving this treatment.
  • The study identifies variations in the time to onset (TTO) and severity of PN among different ADCs, emphasizing the importance of personalized risk assessment and management strategies.
  • Trastuzumab emtansine shows the highest mortality rate among ADCs with tubulin-binding payloads, suggesting the need for heightened vigilance and proactive intervention in affected patients.

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.

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

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

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

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.

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