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PM577a

Phase 1

Wilson Disease | Small molecule | Rare Disease |Prime Medicine, Inc.|Last Updated: Sep 3, 2026

Target and mechanism

Molecular targetATP7B
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

PM577a · 1 trial · 3 indications

Phase 1 1
NCT07748403A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)Wilson Disease
RECRUITING42 Analytics
PHASE1RECRUITING
A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)
Wilson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of PM577a. Quantified by frequency and severity of treatment emergent adverse events (TEAEs).
Post-infusion through Week 48

Secondary Endpoints

Frequency and severity of Dose Limiting Toxicities (DLTs)
Infusion through the 14-day post infusion DLT observation period
Evidence of improved copper metabolism based on meeting the criteria to stop standard of care (SOC) therapy (chelation or zinc), including stable or improving non-ceruloplasmin bound copper levels and liver function tests.
Infusion through Week 48
Percent of participants with non-ceruloplasmin bound copper (NCC)
Weeks 12, 24, and 48 post-infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PM577aEXPERIMENTALPM577a is a sterile suspension of lipid nanoparticle (LNP)-formulated Prime Editors (PEs) intended for single dose intravenous (IV) infusion for the treatment of Wilson disease (WD).

Interventions

NameTypeDescription
PM577aDRUGPM577a is being evaluated in participants with Wilson disease caused by biallelic pathogenic, likely pathogenic, or suspected pathogenic ATP7B variants, including at least one p.H1069Q allele.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Confirmed Wilson Disease (WD) diagnosis as determined by medical history consistent with WD * Historical genetic analysis demonstrating biallelic pathogenic, likely pathogenic, or suspected pathogenic ATP7B variants, including at least one p.H1069Q allele. * Treated and stable...

Countries:United StatesNew Zealand
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07748403startDate: changed
LOWSep 3, 2026NCT07748403startDate: changed
LOWSep 1, 2026NCT07748403Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 1, 2026NCT07748403Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07748403lastUpdatePostDate: changed
LOWAug 11, 2026NCT07748403lastUpdatePostDate: changed
LOWAug 5, 2026NCT07748403NEW_TRIAL: changed

Frequently asked questions about PM577a

What is PM577a used for?

PM577a is an investigational therapy being developed for Wilson Disease, a rare genetic disorder of copper metabolism. It is designed to address the underlying genetic cause of the condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does PM577a target?

PM577a targets the ATP7B gene, which is mutated in Wilson Disease. By targeting this gene, the therapy aims to correct the underlying genetic defect responsible for impaired copper transport in the body. This approach is intended to address the root cause of the disease rather than just managing symptoms.

Who is developing PM577a?

PM577a is being developed by Prime Medicine, Inc., a biotechnology company publicly traded under the ticker symbol PRME. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for Wilson Disease.

What phase is PM577a in?

PM577a is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with Wilson Disease.

What clinical trials is PM577a in?

PM577a is being studied in a Phase 1 clinical trial registered as NCT07748403. This open-label, uncontrolled study is evaluating the safety and efficacy of PM577 in participants with Wilson Disease. The trial is recruiting up to 42 participants aged 12 years and older in the United States and New Zealand.

Is PM577a the same as PM577?

PM577a is closely related to PM577, as both names appear in the context of the same clinical development program. The Phase 1 trial NCT07748403 is titled 'A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease,' indicating that PM577a and PM577 refer to the same investigational therapy.