Lecanemab ARIA Rates Unaffected by Centiloid Level, AB-1005 Meets Primary End Point, Fremanezumab Safe in Obese Patients With Migraine

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In a new analysis of the phase 3 Clarity AD trial (NCT03887455), the study that led to lecanemab’s (Leqembi; Eisai) approval, findings showed a similar rate of amyloid-related imaging abnormalities due to edema (ARIA-E) when categorizing patients by baseline amyloid PET tertile centiloid levels and clinical subgroup. Apolipoprotein e4 (APOE4) zygosity was shown to have no impact on results across subgroups as well. Presented at the 2024 American Academy of Neurology (AAN) Annual Meeting, held April 13-18, in Denver, Colorado, the analysis included 1107 patients with mild cognitive impairment (MCI; lecanemab: n = 552; placebo: n = 555) and 688 patients with mild AD (lecanemab: n = 346; placebo: n = 342). Using baseline centiloid tertiles, the event rates were 8.5% and 3.3% for the low tertile (≤68.185), 15.3% and 1.6% in the middle tertile (>68.185-101.245), and 13.4% and 0.9% in the highest tertile (>101.245) for lecanemab and placebo groups, respectively.

Newly presented data from a phase 1b study (NCT04167540) assessing AskBio’s investigational gene therapy AB-1005 in patients with Parkinson disease (PD) showed that the therapy met its primary end point of successful putamen coverage and was safe over an 18-month period. Although the study was small scale, with only 11 patients included, both mild (n = 6) and moderate (n = 5) forms of PD experienced improvements in ON and OFF time with AB-1005. All told, neurosurgical delivery of AB-1005, an investigational adeno-associated viral vector serotype 2 (AAV2) gene therapy containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, resulted in putamen coverage of 63% (±2%), exceeding the goal of greater than 50% coverage. Presented at the 2024 American Academy of Neurology (AAN) Annual Meeting, held April 13-18, in Denver, Colorado, bilateral infusions of the agent within the putamen (up to 1.8 mL) were well tolerated, with no serious adverse events (AEs) associated with the gene therapy or contrast agent. Of note, the company is planning to publish the 18-month results later this year.

In a post-hoc analysis of the phase 3 HALO-LTS study (NCT02638103) and phase 3b FOCUS trial (NCT03308968), treatment with fremanezumab (Ajovy; Teva Pharmaceuticals), an FDA-approved migraine medication, was efficacious and well tolerated over a 6-month period in patients with both migraine and obesity. The data was consistent with previous fremanezumab studies and support the use of this agent for migraine prevention in a wide population of patients. Despite BMI-high patients having more self-reported comorbidities, these individuals reported a greater change in monthly migraine days (MMDs), the primary end point, vs BMI-normal patients (–6.9 vs –5.9) at month 6 in HALO-LTS

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