Treg Treatment Sustains Cognition in AD, FDA Approves Spinal Cord Stimulation Systems, Soticlestat Reduces Seizures in CDD

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

Findings from a proof-of-concept phase 1 study assessing low-dose COYA 301 (Coya Therapeutics), an investigational interleukin-2 (IL-2) treatment, indicated sustained cognition among patients with Alzheimer disease (AD). The therapy also restored peripheral T cell regulatory (Treg) function and ameliorated systemic pro-inflammatory mediators. Comprised of 8 individuals with a confirmed presence of brain amyloid pathology, findings showed statistically significant improvement in mean Mini-Mental State Examination (MMSE) scores after 168 days of treatment. COYA 301 is a combination immunotherapy designed to lower activated T effector cells and activated macrophages/microglia, while increasing Treg function and numbers. In the study, enrolled individuals received monthly 5-day course of subcutaneous low-dose IL-2 for 4 cycles and were followed for an additional 2 months post-treatment.

According to an announcement, the FDA has approved Abbott’s spinal cord stimulation (SCS) devices for the treatment of chronic back pain in individuals who have not or are not eligible to receive back surgery. The new indication spans across the entire SCS program, which includes the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform. The approval was based on the DISTINCT study, the largest randomized controlled trial for SCS in people with chronic back pain for which surgery is not an option. Comprised of 270 individuals who suffered an average of 12.8 years with pain, 72.6% of those in the SCS study arm and 85.2% of those implanted achieved significant back pain reduction compared with only 7.1% of individuals in the conventional medical management (CMM) arm. All of Abbott’s SCS therapies in the US feature the company’s proprietary, low-energy BurstDR waveform, which had efficacy further supported by DISTINCT.

Data from the phase 2 ARCADE study, a pilot trial of soticlestat (Takeda Pharmaceuticals) showed that when used as an adjuvant, treatment with the agent was associated with a decrease in motor seizure frequency in patients with CDKL5 deficiency disorder (CDD) and a decrease in all seizure frequency among both CDD and Chromosome 15q duplication (Dup15q) syndrome groups observed. Also known as TAK-935, administration of the therapy during the 12-week maintenance period was associated with a median change from baseline in motor seizure frequency of +11.7% in the Dup15q syndrome group and –23.6% in the CDD group. The increase observed in the Dup15q syndrome group was "most likely due to the older age of this cohort," the study investigators noted. In addition, safety findings from the study were consistent with previous studies, with no new safety signals identified.

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