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QR-1123

Phase 1

Autosomal Dominant Retinitis Pigmentosa | Small molecule | Ophthalmology |ProQR Therapeutics N.V.|Last Updated: May 6, 2022

Target and mechanism

Molecular targetRHO
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

QR-1123 · 1 trial · 8 indications

Phase 1 1
NCT04123626A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO GeneAutosomal Dominant Retinitis Pigmentosa
ACTIVE NOT_RECRUITING11 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene
Autosomal Dominant Retinitis PigmentosaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and Severity of ocular AEs
up to 12 months

Incidence and severity of ocular adverse events scored based on CTCAC in the study and fellow eye

Incidence and Severity of non-ocular AEs
up to 12 months

Incidence and severity of non-ocular adverse events scored based on CTCAC in the study and fellow eye

Secondary Endpoints

Changes in BCVA
up to 12 months
Changes in LLVA
up to 12 months
Changes in DAC perimetry
up to 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QR-1123 Single dose - dose level 1EXPERIMENTALOpen label Single dose cohort: dose level 1
QR-1123 Single dose - dose level 2EXPERIMENTALOpen label Single dose cohort: dose level
QR-1123 Single dose - dose level 3EXPERIMENTALOpen label Single dose cohort: dose level 3
QR-1123 Single dose - dose level 4EXPERIMENTALOpen label Single dose cohort: dose level 4
QR-1123 Single dose - dose level 5EXPERIMENTALOpen label Single dose cohort: dose level 5
Repeat dose cohort 1EXPERIMENTALDouble-masked, randomized, sham controlled, Repeat dose cohort. Dose levels will be determined following DMC review of obtained safety and efficacy data.

Interventions

NameTypeDescription
QR-1123DRUGunilateral IVT injection
Sham procedureOTHERSham procedures (i.e. no penetration of the globe) closely mimic the active injection and serve to mask subjects to treatment assignment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Main Inclusion Criteria: 1. Male or female, ≥ 18 years of age. 2. Clinical presentation consistent with adRP, based on ophthalmic examinations. 3. Impairment on VF in the opinion of the Investigator, as determined by perimetry. 4. A molecular diagnosis of autosomal dominant form of RP with the P23H...

Countries:United States
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Frequently asked questions about QR-1123

What is QR-1123 used for?

QR-1123 is an investigational small molecule being developed for the treatment of Autosomal Dominant Retinitis Pigmentosa, a hereditary retinal disease that causes progressive vision loss. It is specifically being studied in patients with the P23H mutation in the RHO gene. The drug is administered to adults aged 18 years and older.

What does QR-1123 target?

QR-1123 targets the RHO gene, which encodes rhodopsin, a light-sensitive protein in the retina. The drug is designed to address the P23H mutation in the RHO gene, which is a cause of Autosomal Dominant Retinitis Pigmentosa. By targeting this specific genetic mutation, QR-1123 aims to treat the underlying cause of the disease.

Who is developing QR-1123?

QR-1123 is being developed by ProQR Therapeutics N.V., a biopharmaceutical company listed on the NASDAQ under the ticker symbol PRQR. The company is conducting clinical research on this investigational drug for the treatment of Autosomal Dominant Retinitis Pigmentosa.

What phase is QR-1123 in?

QR-1123 is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 study is evaluating the safety and tolerability of QR-1123 in patients with Autosomal Dominant Retinitis Pigmentosa.

What clinical trials is QR-1123 in?

QR-1123 is being studied in a Phase 1 clinical trial registered as NCT04123626. This study is evaluating the safety and tolerability of QR-1123 in subjects with Autosomal Dominant Retinitis Pigmentosa due to the P23H mutation in the RHO gene. The trial is active but not recruiting, with an enrollment of 11 participants in the United States.

Is QR-1123 the same as a gene therapy?

QR-1123 is a small molecule, not a gene therapy. It is being developed as an investigational treatment for Autosomal Dominant Retinitis Pigmentosa caused by the P23H mutation in the RHO gene. The drug is currently in Phase 1 clinical trials to assess its safety and tolerability.