AbbVie Submits sNDA for Atogepant in Chronic Migraine, Semorinemab Fails in Phase 2 Prodromal Alzheimer Study, StrivePD Software Gets FDA Greenlight

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

Months after announcing positive phase 3 data, AbbVie has submitted a supplemental new drug application (sNDA) to the FDA to expand atogepant’s (Qulipta) indication to include the preventive treatment of chronic migraine. If approved, the medication would be the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved as a preventive treatment for both episodic and chronic migraine.Results from the PROGRESS trial (NCT03855137), a double-blind, placebo-controlled, parallel-group study assessing 60-mg once daily (QD) and 30-mg twice-daily (BID) doses of atogepant, were the basis for the submission. In that study, those in the 60-mg QD and 30-mg BID arms experienced statistically significant reductions of 6.88 and 7.46 in mean monthly migraine days (MMDs), respectively, compared with patients in the placebo arm, who had a decrease of 5.05 MMDs. Atogepant, originally approved in September 2021 as the first and only oral CGRP receptor for the preventive treatment of episodic migraine, continued to show a safe profile in PROGRESS as well. Constipation and nausea were among the most commonly reported (>5%) adverse events (AEs) in the trial.

Newly published data from the phase 2 Tauriel study showed that semorinemab (AC Immune SA/Genentech), a humanized IgG4 monoclonal antibody, was safe and well-tolerated among patients with prodromal to mild Alzheimer disease (AD), but did not slow the rate of cerebral tau accumulation or clinical decline in a 73-week treatment period.The modified intent-to-treat (mITT) cohort, which included 422 individuals aged 50 to 80 years with prodromal to mild AD, showed similar increases on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) for those on semorinemab at multiple doses. To the study authors’ knowledge, this was the first published phase 2 data of an antitau monoclonal antibody in prodromal to mild AD. Lead investigator Edmond Teng, MD, PhD, senior medical research, Genentech, and colleagues concluded that “nevertheless, while the specific role of tau in AD pathogenesis remains uncertain, it remains a compelling target. Additional studies of monoclonal antitau antibodies that target other tau epitopes and/or different stages of AD will help determine whether this mechanistic approach remains viable or whether other antitau strategies should be prioritized for future clinical drug development.”

The FDA has granted 510(k) clearance to Rune Labs’ StrivePD software ecosystem, an application that collects data on symptoms of patients with Parkinson disease (PD) using an Apple Watch, with the intention of improving care management and clinical trial design. Patients using the app can track and log their symptoms, thus enabling greater control of their disease. The clearance opens the door for thousands of patients already using the tool to participate in clinical trials that could have significant impacts on future therapeutics. Additionally, the hope is that StrivePD may help locate and facilitate patients with prodromal PD, the stage at which individuals do not fulfill the diagnostic criteria for PD but do exhibit signs and symptoms. As part of an existing partnership with Medtronic, the StrivePD app will be utilized for clinicians interpreting data on patients who use Medtronic’s Percept PC Deep Brain Stimulation (DBS) device, which received FDA approval in June 2021. The two companies announced the collaboration in November 2021, which uses Rune’s proprieatary software platform to integrate, analyze, and display data captured from the neurostimulator, along with data from the StrivePD application and other sources.

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