ALZ-801 Enters Open-Label Studies, Subcutaneous Ocrelizumab Gets Positive EU Recommendation, FDA Approves Sprinkle Formulation of Valbenazine

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

Alzheon, the drug manufacturers of ALZ-801, an investigational oral disease-modifying therapy in development for early-stage Alzheimer disease (AD), has announced patient dosing in an open-label extension its pivotal phase 3 APOLLOE4 trial (NCT04770220). The trial, a follow-up to a successful phase 2 biomarker study (NCT04693520), is fully enrolled with topline data expected in the third quarter of 2024. APOLLOE4, a double-blind, randomized trial, is designed to evaluate the efficacy, safety, biomarker, and imaging effects of 265 mg twice daily oral dose of ALZ-801 in 325 patients with early AD who have 2 copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who make up approximately 15% of patients with AD. Supported by a $51 million grant from the National Institute on Aging, the 78-week study will primarily assess effects on cognition, determined using the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog) as the primary end point.

According to an announcement from Roche, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for a subcutaneous (SC) administration of ocrelizumab (Ocrevus), the only marketed therapy to treat both progressive and relapsing multiple sclerosis (MS). A final decision on its approval from the EU is expected mid-2024. Data supporting the use of SC ocrelizumab stems from the phase 3 OCARINA 2 trial (NCT05232825), a global, randomized study that compared the pharmacokinetics of SC ocrelizumab with its intravenous (IV) infusion, the formulation for which it was approved in. Initial study data presented at MSMilan 2023, the joint ECTRIMS-ACTRIMS meeting, showed that a 920-mg SC dose formulation was comparable to its 600-mg IV counterpart in terms of clinical benefit.

The FDA has approved Neurocrine Biosciences’ therapy valbenazine (Ingrezza) oral granules, a new sprinkle formulation of the treatment capsules for oral administration, for patients with tardive dyskinesia (TD) or chorea associated with Huntington disease (HD). The oral granules capsules (40 mg, 60 mg and 80 mg) are intended to be opened for sprinkling on soft foods prior to administration. The new drug application (NDA) filing for the sprinkle formulation included chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of the oral granule sprinkle capsules compared with the currently approved valbenazine capsules.2 Valbenazine is currently available as the only single-capsule, once-daily treatment option with no complex titration for adults with TD and the treatment of chorea associated with HD.

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