Welcome to this special edition of Neurology News Network. I'm Marco Meglio.
According to a new announcement from Eisai, the company has received FDA fast track for its investigational drug etalanetug, an anti-tau antibody that targets specific tau species containing microtubule binding region (MTBR) for Alzheimer disease (AD).1 Etalanetug is currently being evaluated with a standard of care treatment, an anti-amyloid β protofibril antibody, lecanemab (Leqembi; Eisai), in two clinical trials: the Tau NexGen phase 2/3 clinical trial (NCT05269394) for dominantly inherited AD (DIAD), led by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) at Washington University School of Medicine in St. Louis, and a Phase II clinical trial (Study 202, NCT06602258) targeting sporadic early AD.
New late-breaking interim data from TEMPO-4, a phase 3 open-label extension study, revealed that tavapadon (AbbVie), an investigational selective dopamine D1/D5 receptor partial agonist, maintained a favorable long-term safety profile, in addition to improvements seen in motor function, among patients with Parkinson disease (PD). The interim analysis, presented as a late-breaker at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS), held October 5-9, in Honolulu, Hawaii, included 468 patients who rolled over, and 524 previously untreated participants (placebo rollover: n = 471; de novo; n = 53). Pooling both cohorts (n = 991), the most common treatment-emergent adverse event (TEAE) observed with tavapadon was nausea (11.0%), followed by dizziness (10.6%), headache (9.6%), fall (9.2%), COVID-19 (9.1%), and constipation (5.5%).
Researchers recently presented positive efficacy data from the first patient in an ongoing phase 1 open-label dose-escalation trial (NCT06778265) assessing UX-DA001 (Unixell Biotech), an investigational iPSC-derived autologous cell therapy for the treatment of Parkinson disease (PD), at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS), held October 5-9, in Honolulu, Hawaii. The study’s first participant was a woman with moderate-to-severe PD who, despite taking 4 daily medications for PD before surgery, who continued to experience substantial motor fluctuations and disabling nonmotor symptoms. At 3 months of follow-up, findings revealed that the patient improved by 21 points in the OFF stage (47.7%) and by 8 points in the ON state (42.1%), as measured by Movement Disorders Society Unified PD Rating Scale (MDS-UPDRS) Part III scores.
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