Atogepant Outperforms Topiramate, IND Accepted for ORX142, Prasinezumab Heads to Phase 3 Parkinson Disease Studies

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

Newly announced data from the phase 3 TEMPLE trial, a head-to-head study comparing atogepant (Qulipta; AbbVie) to topiramate (Topamax), 2 FDA-approved migraine medications, showed that atogepant met its primary end point, outperforming the anticonvulsant medication in both efficacy and safety measures. In this multicenter, double-blind, active-controlled trial, 545 patients with episodic or chronic migraine were randomly assigned to either atogepant or topiramate for a 24-week treatment period, followed by an open-label extension. All told, atogepant met its primary end point of tolerability, with fewer patients discontinuing treatment because of adverse events (AEs). Overall, 12.1% of atogepant-treated patients discontinued because of safety issues compared with 29.6% of those on topiramate, reflecting a relative risk of 0.41 (95% CI, 0.28-0.59; P <.0001).

According to a recent announcement, the FDA has accepted Centessa Pharmaceuticals’ investigational new drug application (IND) for ORX142, an investigational orexin receptor 2 agonist (OX2R), to be tested in a phase 1 clinical study of healthy volunteers. ORX142, which is being studied as a treatment for a select neurological and neurodegenerative disorders, will have its safety, tolerability, and pharmacokinetics evaluated in the phase 1 study. The study, expected to start imminently, with clinical data expected later this year, will test both single-ascending and multiple-ascending doses of the agent in healthy volunteers.

According to a new announcement, Roche is planning to advance its investigational anti-alpha-synuclein antibody prasinezumab into phase 3 trials of Parkinson disease (PD), further testing the agent’s therapeutic potential as a PD treatment. The company has not relayed any information yet on the design or build of such study, with more expected to come over the coming months. Prasinezumab is designed to bind aggregated alpha-synuclein, a neuronal protein that, under pathological conditions, misfolds and aggregates into insoluble fibrils, forming Lewy bodies–a hallmark of PD. These aggregates are believed to be neurotoxic, disrupting cellular processes, spreading between neurons, and contributing to progressive neuronal degeneration, particularly in dopaminergic pathways. Preventing aggregated alpha-synuclein is considered a disease-modifying approach, contrasting to typical symptomatic treatments.

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