Experimental gene 'Silencer' therapy enters human testing for rare muscle disease

NCT ID NCT06907875

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing EPI-321, a one-time gene therapy designed to silence the faulty gene that causes facioscapulohumeral muscular dystrophy (FSHD). The study will enroll 12 adults with FSHD Type 1 to see if the treatment is safe and tolerable, and whether it shows any signs of working. Participants receive a single IV dose and are monitored for about 5 years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

EPI-321 (a gene therapy that aims to silence the faulty gene causing FSHD)

What this could lead to

If it works, this could point toward a treatment that stops or slows muscle damage in FSHD, a rare muscular dystrophy.

What could go wrong

This is a very early, small trial (12 people) focused on safety, not proof of effectiveness. The therapy is new and may not work or could cause side effects.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

facioscapulohumeral muscular dystrophy facioscapulohumeral muscular dystrophy 1 muscular dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • David Geffen School of Medicine at University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Kennedy Krieger Institute, Center for Genetic Muscle Disorders

    RECRUITING

    Baltimore, Maryland, 21205, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Pacific Clinical Research Network

    RECRUITING

    Auckland, 0622, New Zealand

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Rare Disease Research

    RECRUITING

    Atlanta, Georgia, 303329, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Royal Alfred Hospital

    RECRUITING

    Sydney, New South Wales, 2050, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01605, United States

    Contact Email: •••••@•••••

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Utah Program for Inherited Neuromuscular Disorders - University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••