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PTC124

Phase 2

Cystic Fibrosis | Small molecule | Respiratory |PTC Therapeutics, Inc.|Last Updated: Dec 13, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

PTC124 · 3 trials · 2 indications

Phase 2 3
NCT00351078PTC124 for the Treatment of Cystic FibrosisCystic Fibrosis
COMPLETED19 Analytics
NCT00264888Safety and Efficacy Study of PTC124 in Duchenne Muscular DystrophyDuchenne Muscular Dystrophy
COMPLETED38 Analytics
NCT00234663PTC124 for Cystic FibrosisCystic Fibrosis
COMPLETED24 Analytics
PHASE2COMPLETED
PTC124 for the Treatment of Cystic Fibrosis
Cystic FibrosisUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of PTC124 in Duchenne Muscular Dystrophy
Duchenne Muscular DystrophyUnlock trial analytics
PHASE2COMPLETED
PTC124 for Cystic Fibrosis
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

CFTR activity as assessed by nasal transepithelial potential difference (TEPD)
84 days
Dystrophin expression as assessed by immunofluorescence evaluation of tissue obtained by biopsy of the extensor digitorum brevis (EDB) muscle of the foot or tibialis anterior (TA) muscle of the leg

Secondary Endpoints

Side effects
84 days
Presence of CFTR protein and mRNA
84 days
Compliance with treatment
84 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PTC124 POEXPERIMENTAL4-, 4-, and 8-mg/kg TID first 14 days of cycle 10-, 10-, and 20-mg/kg TID second 14 days of cycle 28 day study

Interventions

NameTypeDescription
PTC124DRUG4-,4-, and 8-mg/kg PO first 14 days 10-, 10-, and 20-mg/kg TID second 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients must meet all of the following conditions to be eligible for enrollment into the study: * Completion of ≥ 1 cycle of PTC124 treatment in the previous Phase 2a study protocol (Protocol Number PTC124-GD-005-CF). * Abnormal nasal epithelial TEPD total chloride conductance...

Countries:IsraelUnited States
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Frequently asked questions about PTC124

What is PTC124 used for?

PTC124 is an investigational small molecule being studied for the treatment of Duchenne Muscular Dystrophy and Cystic Fibrosis. It is being developed by PTC Therapeutics, Inc. (NASDAQ: PTCT). The drug has completed Phase 2 clinical trials for both indications, but it is not yet approved and remains in clinical development.

How does PTC124 work?

PTC124 is a small molecule that targets the underlying genetic defects in Duchenne Muscular Dystrophy and Cystic Fibrosis. It is designed to promote readthrough of premature stop codons, allowing the production of full-length, functional proteins. This mechanism is intended to address the root cause of these diseases.

Who makes PTC124?

PTC124 is being developed by PTC Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol PTCT. The company is conducting clinical trials to evaluate the safety and efficacy of PTC124 in patients with Duchenne Muscular Dystrophy and Cystic Fibrosis.

What phase is PTC124 in?

PTC124 is in Phase 2 clinical development. It has completed two Phase 2 trials for Cystic Fibrosis and one Phase 2 trial for Duchenne Muscular Dystrophy. All trials are completed, and the drug is not yet approved by regulatory authorities. It remains an investigational agent.

What clinical trials is PTC124 in?

PTC124 has been studied in three completed Phase 2 trials. NCT00234663 and NCT00351078 evaluated PTC124 in Cystic Fibrosis, while NCT00264888 assessed its safety and efficacy in Duchenne Muscular Dystrophy. These trials enrolled a total of 43 participants across the United States and Israel.

Is PTC124 the same as ataluren?

PTC124 is also known as ataluren. The drug is being developed by PTC Therapeutics for the treatment of Duchenne Muscular Dystrophy and Cystic Fibrosis. It has completed Phase 2 trials, but it is not yet approved for these indications.