Evoke SCS System Shows Positive 36-Month Results, FDA Lifts Hold on FORTIS, Complete Response Letter Issued for Donanemab

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

Presented at the 2023 North American Neuromodulation Society (NANS) annual meeting, new 36-month data from the EVOKE clinical trial (NCT02924129) showed never-before-seen outcomes in treating back and leg pain using Saluda Medical’s Evoke SmartSCS spinal cord stimulation (SPS) system. Presented by Nagy Mekhail, director, Evidence-Based Pain Management Research, Cleveland Clinic, findings showed that 78% of the 134-patient intention-to-treat cohort who received the closed-loop arm system achieved at least 50% pain reduction. Additionally, 49% of this population achieved at least an 80% reduction as well. The pivotal EVOKE study randomly assigned patients with intractable pain of the back and legs 1:1 to ECAP-controlled, closed-loop SCS or fixed-output, open-loop SCS. The same neuromodulation system (Evoke System) served as the investigational and control device, as it offered both ECAP-controlled closed-loop SCS and open-loop SCS.

Recently, the FDA lifted a clinical hold on Astellas Pharma's phase 1/2 FORTIS clinical trial assessing its investigational agent AT845 for the treatment of adults with late-onset Pompe disease (LOPD). FORTIS is the first-in-human trial of the gene replacement therapy, which is designed to use the adeno-associated virus vector 8 to deliver a functional copy of the GAA gene under a muscle-specific promoter. FORTIS formerly was placed on hold because of a case of a serious adverse event (AE) of peripheral sensory neuropathy. The AE was classified as grade 1 and mild although it was serious because of medical significance. Therefore, the FDA told Astellas that there was not enough information for assessing the risks of the participants and that more information is needed about the incidence of neuropathy.

The FDA issued a complete response letter to Eli Lilly for its investigational antiamyloid therapy donanemab, a humanized IgG1 monoclonal antibody, for the treatment of symptomatic Alzheimer disease (AD). A lack of participants who received continuous treatment with donanemab for at least 12 months was the reason for the decision, with no other noted concerns. In its response letter, the FDA requested the company provide data from at least 100 patients who have received a minimum of 12 months of continuous treatment with donanemab. The phase 2 TRAILBLAZER-ALZ study, which served as the basis for the biologics license application of donanemab, included more than 100 patients; however, it was designed so that patients would complete the treatment course once they reached a predefined level of amyloid plaque clearance.

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