SLS-005 Performs Better Without AMX0035, Nerivio Gains Commercial Coverage, UB-312 Reduces α-Synuclein


Neurology News Network for the week ending March 23, 2024. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

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

Newly announced topline findings from the SLS-005 (intravenous trehalose) regimen of the HEALEY ALS Platform trial showed that the agent failed to demonstrate statistical significance on the primary end point; however, it did perform significantly better in a subgroup of individuals who were not on concomitant AMX0035. After 24 weeks of treatment, a prespecified subgroup of patients with amyotrophic lateral sclerosis (ALS) on SLS-005 without AMX0035 showed a 22% improvement in ALS Functional Rating Scale (ALSFRS-R) assessment adjusted for mortality, with an 89% success probability. Using the full analysis set, treatment with the therapy resulted in a 13% improvement in function and mortality with an 88% success probability (vs the pre-specified 98%) on the overall population.

According to a recent announcement, Theranica’s remote electrical neuromodulation (REN) device Nerivio, an FDA-approved wearable for acute and preventive migraine, will now be commercially covered under Highmark. With the decision, Nerivio becomes the first ever nonpharmacological migraine treatment to receive commercial coverage in the US. Controlled by a smartphone app and self-administered, the Nerivio REN wearable is a migraine treatment that wraps around the upper arm and uses sub-painful REN to activate nociceptive nerve fibers in the arm. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment. To date, it remains the only FDA-cleared device to utilize REN to prevent and treat migraine.

In new data from a randomized, double-blind, placebo-controlled phase 1 clinical trial (NCT04075318), findings showed that antibodies derived from UB-312 (Vaxxinity), an investigational immunotherapeutic, reduced the pathological α-synuclein (α-Syn) in cerebrospinal fluid (CSF) of patients with Parkinson disease (PD). Among 20 patients with PD, UB-312-induced antibodies showed preferential binding to aggregated α-Syn and almost no binding to normal monomeric α-Syn, as measured by dot blot. Following a single priming regimen, patients treated with UB-312 in the 300/100/100 µg dosing group showed a 20% decrease from baseline in aggregated α-Syn in the CSF compared with a 3% increase in the placebo group (P <.05), as measured by a seed amplification assay.

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