Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals is conducting a groundbreaking study titled ‘First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ALN-SOD in Participants With Amyotrophic Lateral Sclerosis and SOD1 Mutations.’ The study aims to assess the safety and tolerability of ALN-SOD, an experimental drug for ALS patients with SOD1 gene mutations, marking its first human trial.
The study is testing ALN-SOD, administered via intrathecal injection, to determine its effects on ALS symptoms, biomarkers, and potential antibody development. This drug is designed to target ALS caused by SOD1 mutations, offering a potential new treatment avenue.
The study is interventional, randomized, and follows a sequential model with a quadruple masking approach. It includes a crossover design with an initial double-blind treatment period followed by an open-label phase, focusing primarily on treatment.
Key dates include the study’s start on August 28, 2024, with the latest update on August 6, 2025. These dates are crucial for tracking progress and ensuring timely updates on the study’s outcomes.
For investors, this study could significantly impact Regeneron’s stock performance, as successful results may enhance investor confidence and market positioning against competitors. The ongoing research reflects Regeneron’s commitment to pioneering treatments in the competitive pharmaceutical landscape.
The study is currently recruiting, with further details available on the ClinicalTrials portal.