Clinical Trial News

Mindstate Design Labs received FDA and EMA approval for human trials of MSD-001, described as 'psychedelic tofu' for its mild effects. The trials aim to validate the neurotech AI platform, Osmanthus, designed to create tailored altered states of consciousness. CEO Dillan DiNardo envisions using psychedelics as tools to understand and design specific mental states, potentially addressing conditions beyond traditional psychedelic uses.

Acadia Pharmaceuticals' COMPASS-PWS Clinical trial, enrolling PWS patients aged 5-30 with hyperphagia, aims to evaluate carbetocin's safety and efficacy via nasal spray. The phase 3 study involves 170 participants in a double-blind setup, with key eligibility criteria including no recent food interventions or treatment studies. The trial includes 5 clinic visits and an optional 3-year open-label extension. For details, visit compasspws.com.

SOPHiA GENETICS and Boundless Bio collaborate to develop an ecDNA detection algorithm for clinical trial enrollment in Boundless Bio's POTENTIATE Phase 1/2 study of BBI-355, an ecDNA-directed therapy for oncogene amplified cancers. Precision for Medicine supports the trial with its laboratory services, contributing to a novel workflow for patient sample processing.

Roche's Phase II study of BTK inhibitor fenebrutinib shows 96% of RMS patients relapse-free at one year, with no disability change and 99% free of T1-Gd+ lesions. The safety profile remains consistent, with ongoing Phase III trials expected to validate these results.

Kizewski discusses SOMS's impact on clinical trials, highlighting its ability to identify biomarkers, optimize patient subgroups, and predict outcomes, significantly enhancing trial success and FDA approval rates.

The First Time Disclosures session at ACS Fall 2024 in Denver, organized by the MEDI Division of ACS, presented 13 innovative small molecules in clinical development, including Novartis’ IWY357 and Vividion’s KEAP1 covalent activator.

Brain+ starts clinical trial of BrainBlossom, its next-gen cognitive training tech for Mild Cognitive Impairment (MCI), in collaboration with Aalborg University Hospital. The trial aims to test the feasibility and impact of BrainBlossom as a home-delivered treatment for MCI, with results expected in early 2025. Success could lead to a larger trial for regulatory data and a partnership for commercialization.

Crestone announces positive Phase 2 trial results for CRS3123 in treating C. difficile infections, showing high clinical cure rates, low recurrence, and safety. NIAID funds $4.5 million for further studies.

A Middle Tennessee neurology office is conducting clinical trials for a potentially groundbreaking Alzheimer’s drug, BenfoTeam, which uses a lab-made version of vitamin B1 to possibly slow down or reverse the disease. The trial, focusing on cognitive function and daily routine activities, is open to people aged 50-89 with mild memory concerns or mild Alzheimer’s, not in long-term nursing care, and willing to participate in an 18-month program.

Evommune initiated a Phase II trial of EVO756 to treat chronic inducible urticaria (CIndU) in adults, aiming to assess safety and efficacy in 30 patients with symptomatic dermographism or cold urticaria. The trial uses disease-specific provocation thresholds to measure treatment response, with patients receiving EVO756 orally once daily for four weeks. EVO756, a selective MRGPRX2 antagonist, could offer a new oral treatment for mast cell-mediated diseases and rapidly alleviate itching.