Clinical Trial News

Invivyd, Inc. announced dosing of the first participants in the Phase 1 clinical trial of VYD2311, a next-gen mAb candidate for COVID-19, showing high in vitro neutralization potency against post-Omicron variants. The trial, conducted in Australia, will evaluate safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311, with preliminary data expected in Q4 2024. VYD2311 was discovered via affinity maturation against recent SARS-CoV-2 variants and is designed for intramuscular administration for patient convenience. The company also highlighted PEMGARDA™, an investigational mAb authorized for emergency use by the FDA for pre-exposure prophylaxis of COVID-19 in immunocompromised patients.

FDA clears BlueRock Therapeutics' IND for Phase I/IIa trial of OpCT-001, an iPSC-derived cell therapy for primary photoreceptor diseases. The study aims to assess safety, tolerability, and efficacy of the therapy, with multiple US sites recruiting participants. OpCT-001 was licensed from FUJIFILM Cellular Dynamics and Opsis Therapeutics, with support from the latter in IND-enabling activities.

Merck and EyeBio announce the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret (MK-3000) for diabetic macular edema (DME). MK-3000 is an investigational tetravalent, tri-specific antibody acting as an agonist of the Wnt signaling pathway. The trial follows positive results from the Phase 1/2 AMARONE study.

Immunic, Inc. announces enrollment of the first patient in a phase 2 clinical trial of vidofludimus calcium for Post COVID Syndrome, aiming to reduce fatigue and Epstein-Barr virus reactivation, with potential implications for multiple sclerosis treatment.

A wearable heart monitor increases A-fib detection by over 50% but did not reduce strokes in a study involving over 12,000 older Americans. The study, led by Dr. Renato Lopes of Duke Clinical Research Institute, was presented at the European Society of Cardiology meeting and published in the Journal of the American College of Cardiology.

NCCIH, with support from the NIH HEAL Initiative, published a notice of funding opportunity for pragmatic clinical trials within the NIH-DOD-VA Pain Management Collaboratory, focusing on nonopioid pain management approaches for veterans, military personnel, and their families.

Axcellant, a European CRO in Warsaw, announces a groundbreaking clinical trial in nuclear medicine that could change standard care, impacting over 20 million US patients and 200 million worldwide. The trial, supported by leading US experts, aims to develop a new radioactive compound as a diagnostic agent, with FDA approval for the study plan.

Correction: Phase I/Ib clinical trial of sabatolimab, an anti–TIM-3 antibody, alone and in combination with spartalizumab, an anti–PD-1 antibody, in advanced solid tumors. Clin Cancer Res 1 September 2024; 30 (17): 3957. https://doi.org/10.1158/1078-0432.CCR-24-2131

For CTIMPs not submitted through Combined Review, an End of a Trial Form must be sent to MHRA within 90 days of the trial's end, with no further substantial amendments allowed. A Clinical Trial Summary Report is required. The form must also be sent to the ethics committee, and NHS R&D offices notified. For non-CTIMPs, notification to the relevant ethics committee is required.

Denali Therapeutics has announced its intention to seek accelerated approval for DNL310, a treatment for MPS II (Hunter Syndrome), following positive discussions with the FDA. The company plans to submit a biologics license application in early 2025.