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Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9

NCT07678775 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-07-02

No results posted yet for this study

Summary

This is an open-label extension (rollover) study designed to evaluate the long-term safety and efficacy of BBP-418 (ribitol) in participants with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9) who have previously participated in Study MLB-01-005 (Fortify).

Participants will receive BBP-418 administered orally at protocol-defined doses and schedules. The study will assess long-term safety through monitoring of adverse events, clinical laboratory evaluations, and other safety assessments. Efficacy will be evaluated using functional measures and other clinical endpoints relevant to LGMD2I/R9.

Participants will be followed for up to 36 months, with a final safety follow-up assessment conducted approximately 30 days after the last dose of study drug.

Conditions

  • Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I)

Interventions

DRUG

BBP-418 (ribitol)

Drug: BBP-418. Single arm. Participants who completed Study MLB-01-005 and meet eligibility criteria will receive BBP-418 (ribitol) taken orally twice daily at 9 or 12g (based on body weight measured) for up to 36 months.

Sponsors & Collaborators

  • ML Bio Solutions, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2030-10-31
Completion
2030-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Norway
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678775 on ClinicalTrials.gov