Clinical Trial News

Rise Therapeutics received FDA clearance for its IND application to start a Phase 1 clinical trial of R-2487, a novel oral immunotherapy for rheumatoid arthritis. R-2487 aims to induce regulatory T cells and reset immune balance, targeting the disease's root cause. The trial will assess safety, tolerability, and clinical activity in up to 36 participants.

Sequana Medical has announced additional positive data from the POSEIDON study, showing that the alfapump maintains a strong safety and efficacy profile at 12 months post-implantation for patients with recurrent or refractory ascites. The data also indicates a strong preference among US patients for the alfapump over standard care, with the company on track for a PMA submission by year-end.

Traverse Biotech, Inc. received a Phase 1 SBIR Grant from the NCI to develop a bispecific antibody for treating Non-small Cell Lung Cancer. The grant supports validating a novel tumor antigen and advancing cancer immunotherapy. Traverse Biotech focuses on accelerating therapeutic development through partnerships and a lean operating structure.

BIMZELX® (bimekizumab-bkzx), the first IL-17A and IL-17F inhibitor, is FDA-approved for treating moderate-to-severe plaque psoriasis in adults. Supported by three Phase 3 trials, it offers rapid, lasting skin clearance, with 85-91% achieving clear or almost clear skin by week 16. UCB anticipates global peak sales exceeding €4 billion.

US FDA approved Concept Medical’s MagicTouch SCB, a Sirolimus Coated Balloon, for small vessel disease treatment, marking its third IDE approval. This enables pivotal clinical studies for safety and effectiveness, aiming for future PMA. MagicTouch SCB, widely used globally, offers a new option for CAD treatment in the USA, where no FDA-approved drug-coated balloons exist.

Abbott's TactiFlex™ Ablation Catheter, Sensor Enabled™, the first with a flexible tip and contact force technology, received FDA approval for treating atrial fibrillation (AFib). It offers reduced procedure times, better safety, and pairs with Abbott’s EnSite X EP System for precise ablation, showing over 99% acute procedural success in studies.

The NHS is set to provide a potentially curative new treatment, glofitamab, for patients with diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma. Approved by the MHRA and NICE, this treatment offers hope for patients who have not responded to previous therapies, with clinical trials showing promising results.

Spectral Medical Inc. announced the Mayo Clinic as its 19th site for the Tigris trial, a Phase 3 study on PMX treatment for endotoxemia and septic shock. Spectral is advancing PMX, a therapeutic device for septic shock, with FDA Breakthrough Device Designation. PMX is approved in Japan and Europe, used on over 340,000 patients.

Tilray Medical, part of Tilray Brands, Inc., is contributing to a clinical trial in Spain to study medical cannabis's efficacy against glioblastoma, a severe brain cancer. The trial involves 30 patients and is a collaboration with GEINO and Complutense University of Madrid, funded by the Medical Cannabis Bike Tour Foundation.

Immix Biopharma completed its 3rd engineering batch of NXC-201, a BCMA-targeted CAR-T cell therapy, at its California facility, marking a milestone for U.S. manufacturing capability. NXC-201, with a 100% response rate in AL Amyloidosis patients, aims to expand CAR-T therapy access, potentially becoming the first outpatient CAR-T.