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A Phase 1/2a Double-Blind, Placebo-controlled, Single- and Multiple Ascending Dose Study to Assess the Safety, Tolerability, PK, PD and Efficacy of IV Administration of ATX-01 in Male and Female Participants Aged 18 to 64 with Classic DM1

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Trial Profile

A Phase 1/2a Double-Blind, Placebo-controlled, Single- and Multiple Ascending Dose Study to Assess the Safety, Tolerability, PK, PD and Efficacy of IV Administration of ATX-01 in Male and Female Participants Aged 18 to 64 with Classic DM1

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Nov 2025

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At a glance

  • Drugs ARTHEx 01 (Primary)
  • Indications Myotonic dystrophy
  • Focus Adverse reactions; First in man
  • Acronyms ArthemiR
  • Sponsors ARTHEx Biotech

Most Recent Events

  • 17 Sep 2025 According to an ARTHEx Biotech media release, initial clinical data expected in 2026.
  • 17 Sep 2025 According to an ARTHEx Biotech media release, proceeds from the financing will be used to advance the global clinical development of ATX-01 for Myotonic Dystrophy Type 1 (DM1), including this study and the preparation for an open-label extension to support a registrational study.
  • 17 Sep 2025 According to an ARTHEx Biotech media release, company announced the successful closing of its upsized Series B financing with new investor Bpifrance, bringing the total size of the funding round to $87 million.

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