Clinical Trial News

Leading physicians and researchers will present results from 21 clinical trials at the 2024 VIVA and The VEINS conferences at Wynn Las Vegas, emphasizing innovation and multidisciplinary learning in vascular medicine and intervention.

FDA approves nimodipine (Nymalize) oral solution in 30 mg/5 mL prefilled ENFit syringes, enhancing safety for subarachnoid hemorrhage patients.

Boehringer Ingelheim and CDR-Life report positive Phase I results for BI 771716, an antibody fragment targeting geographic atrophy (GA), meeting safety endpoints. The companies plan to initiate Phase II trials in early 2025, aiming to preserve vision in GA patients, a severe form of AMD leading to irreversible vision loss. BI 771716's design allows optimized retinal penetration and efficacy potential.

Splash Clinical and Cambridge Cognition partner to integrate CANTAB into Splash's patient recruitment platform, enhancing CNS trial recruitment efficiency and quality.

Aleksandra Staniszewska et al. developed a core outcome set for interventions in diabetes-related foot ulceration studies, published in *Diabetes Care* 2024; dc241112. https://doi.org/10.2337/dc24-1112

Cartesian Therapeutics has initiated a phase 1 trial for Descartes-15, a next-gen autologous mRNA-engineered CAR-T therapy targeting BCMA for relapsed/refractory multiple myeloma, featuring predictable pharmacokinetics and enhanced CAR stability, with outpatient delivery potential. Preclinical data shows Descartes-15 outperforming Descartes-08 in CAR expression and target-specific killing. The trial aims to assess safety and tolerability, with plans to expand to autoimmune disease treatment.

TD Cowen maintains Buy rating and $1,050.00 price target for Eli Lilly, following successful Phase III trial results for once-weekly insulin efsitora. Analysts predict potential market impact, with efsitora seen as a competitor to Novo Nordisk's icodec. Eli Lilly's financial model has been revised, reflecting heightened expectations. Recent collaborations and acquisitions, including a deal with EVA Pharma and the acquisition of Morphic Holding, add to the company's growth prospects. Eli Lilly's market capitalization stands at $831.03 billion, with impressive revenue growth and consistent dividend payments.

FDA approved perioperative durvalumab plus neoadjuvant chemotherapy for resectable NSCLC in Aug 2024, based on AEGEAN trial data. This introduces immune checkpoint blockade earlier, potentially increasing cure rates. Key trial outcomes included pathologic complete response and survival, with molecular testing for EGFR/ALK mutations crucial. Patients benefited regardless of PD-L1 status.

Milestone Pharmaceuticals announced positive results from Ji Xing Pharmaceuticals' Phase 3 trial of etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT) in China, meeting primary and secondary endpoints with significant efficacy and safety. The trial aligns with Milestone's RAPID Phase 3 Study. Milestone and Ji Xing have a licensing agreement for etripamil in Greater China, with potential milestone payments and royalties.

Alopexx, Inc. receives investment from Biotech Consortia, Inc. to advance AV0328, a broad-spectrum anti-microbial vaccine targeting PNAG, with potential to treat bacterial, fungal, and parasitic infections. AV0328 completed Phase I trials, showing tolerance and antibody induction against PNAG-expressing pathogens, with an affordable cost of $1 per dose.