RELIEV2-CM Study Launched, Dose-Finding Portion of ANQUR Underway, Anavex Submits EU Application for Blarcamesine

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to a new announcement from ShiraTronics, the company has successfully launched its RELIEV-CM2 study, with the first successful implants in patients with chronic migraine (CM). The study, an FDA-approved investigation device exemption pivotal trial spanning across the United States and Australia, tests the therapeutic effects of the company’s neuromodulation device placed under the skin and arms.The study remains still enrolling, looking for patients who are at least 22 years of age, who’ve had migraine for at least 12 months, experience at least 15 or more headache days per month, and have episodes lasting more than 4 hours. Coming into the study, patients must have no prior treatment with a neurostimulator and no onabotulinumtoxinA injections for purposes other than managing migraine within the last 6 months.

In recent news, QurAlis 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) of patients with amyotrophic lateral sclerosis (ALS). The decision comes after the therapy successfully completed its dose-escalation portion of the trial, as cerebrospinal fluid (CSF) exposure levels met or exceeded the targeted therapeutic range.In the upcoming DRF phase, investigators will assess 2 doses of QRL-201 while including additional biomarkers and a cohort of patients with C9orf72-related ALS in addition to the original cohort of sporadic ALS. In this next step, the study will enroll an additional 48 participants: 32 participants with sporadic ALS and 16 participants with C9orf72-related ALS. In this global, double-blind, placebo-controlled phase 1 trial comprising 64 participants, the primary objective and end point is safety and tolerability of QRL-201.

According to a new announcement, Anavex Life Sciences has submitted its marketing authorization application (MAA) for blarcamesine, a small molecule activator of the sigma-1 receptor (SIGMAR1), as a potential treatment for patients with Alzheimer disease (AD). Thus far, the European Union (EU) has not set a specific prescription drug user fee act date to decide the drug’s fate.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 a confirmed diagnosis of early-stage AD. In the trial, treatment with blarcamesine resulted in 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 Alzheimer’s Disease Assessment Scale-cognitive subscale 13 (ADAS-Cog13), the coprimary end point.²

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