ShiraTronics has announced the launch of its RELIEV-CM2 study, a pivotal trial evaluating a neuromodulation device for chronic migraine. QurAlis is moving forward with its Phase 1 ANQUR trial of QRL-201 for amyotrophic lateral sclerosis (ALS), and Anavex Life Sciences has submitted a marketing authorization application to the European Union for blarcamesine as a potential Alzheimer's disease treatment. These developments mark significant steps in the ongoing efforts to address neurological disorders with limited treatment options.
ShiraTronics' RELIEV-CM2 Study for Chronic Migraine
The RELIEV-CM2 study is an FDA-approved investigation device exemption pivotal trial. It is designed to evaluate the therapeutic effects of ShiraTronics' neuromodulation device in patients with chronic migraine (CM). The device is placed under the skin and arms. The trial is enrolling patients across the United States and Australia who are at least 22 years old, have experienced migraine for at least 12 months, have at least 15 headache days per month, and have episodes lasting more than 4 hours. Exclusion criteria include prior treatment with a neurostimulator or onabotulinumtoxinA injections for migraine management within the last 6 months.
QurAlis' QRL-201 Enters Dose Range-Finding Phase for ALS
QurAlis has announced that its investigational agent QRL-201, a therapy designed to restore STATHMIN-2 (STMN2) expression, is entering the dose range-finding (DRF) portion of its Phase 1 ANQUR clinical trial (NCT05633459) in patients with amyotrophic lateral sclerosis (ALS). This decision follows the successful completion of the dose-escalation portion of the trial, where cerebrospinal fluid (CSF) exposure levels met or exceeded the targeted therapeutic range. The DRF phase will assess two doses of QRL-201, including additional biomarkers and a cohort of patients with C9orf72-related ALS, in addition to the original cohort of sporadic ALS. The study will enroll an additional 48 participants: 32 with sporadic ALS and 16 with C9orf72-related ALS. The primary objective of this global, double-blind, placebo-controlled Phase 1 trial, comprising 64 participants, is to evaluate the safety and tolerability of QRL-201.
Anavex Submits Marketing Authorization Application for Blarcamesine in Alzheimer's Disease
Anavex Life Sciences has submitted its marketing authorization application (MAA) to the European Union for blarcamesine, a small molecule activator of the sigma-1 receptor (SIGMAR1), as a potential treatment for Alzheimer's disease (AD). The application is based on data from the Phase 2/3 AD-004 trial, a randomized, double-blind, placebo-controlled, 48-week study of 508 individuals with early-stage AD. The trial demonstrated that treatment with blarcamesine resulted in a significant slowing of clinical decline by 38.5% in the 50 mg group and by 34.6% in the 30 mg group, relative to placebo, on the Alzheimer’s Disease Assessment Scale-cognitive subscale 13 (ADAS-Cog13), a co-primary endpoint.
