Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Study Overview: Regeneron Pharmaceuticals is conducting a first-in-human study titled ‘First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Intrathecally Administered ALN-SNCA in Participants With Early Parkinson’s Disease.’ The study aims to assess the safety and tolerability of ALN-SNCA, an experimental drug, in individuals with early-stage Parkinson’s disease, a condition characterized by the harmful accumulation of α-synuclein protein in the brain.
Intervention/Treatment: The study tests ALN-SNCA, an investigational drug administered intrathecally, to determine its safety profile and potential to reduce α-synuclein levels in the cerebrospinal fluid, potentially slowing Parkinson’s disease progression.
Study Design: This Phase 1 interventional study employs a randomized, sequential intervention model with a quadruple masking approach, involving participants, care providers, investigators, and outcomes assessors. The primary purpose is treatment-focused.
Study Timeline: The study is set to begin recruitment on October 9, 2025, with the primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on October 9, 2025, marking the study’s initiation phase.
Market Implications: This study could significantly impact Regeneron’s stock performance and investor sentiment, given the potential breakthrough in Parkinson’s treatment. Success in early trials may position Regeneron favorably against competitors in the neurodegenerative disease market, enhancing its portfolio and market share.
The study is ongoing, and further details are available on the ClinicalTrials portal.