Lupin Limited ((IN:LUPIN)) announced an update on their ongoing clinical study.
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Study Overview: Lupin Limited is conducting a study titled ‘An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR in Patients With Non-Dystrophic Myotonias (ACHILLES Study)’. The study aims to evaluate the efficacy and safety of two formulations of mexiletine, a drug used to treat myotonia, a muscle disorder. This study is significant as it could lead to improved treatments for patients with non-dystrophic myotonias.
Intervention/Treatment: The study tests two types of mexiletine: a prolonged-release (PR) version and an immediate-release (IR) version. Mexiletine is intended to manage symptoms of myotonia by stabilizing muscle cell membranes.
Study Design: This is a Phase 3, open-label, randomized, cross-over study. Participants will be randomly assigned to receive either mexiletine PR or IR for 12 weeks, followed by a 7-day washout period, then switched to the opposite treatment. The study is single-masked, meaning participants do not know which treatment they receive first.
Study Timeline: The study began on November 21, 2024. The primary completion date is not specified, but the last update was on September 22, 2025. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: The outcome of this study could impact Lupin Limited’s stock performance positively if the results show a significant improvement in treatment efficacy and safety. This could enhance investor sentiment and position Lupin competitively within the pharmaceutical industry, particularly against other companies developing treatments for myotonia.
The study is ongoing, with further details available on the ClinicalTrials portal.