Novel Drugs & Emergent Therapeutics | Ophthalmology
 
Uveitis Advancements: Priovant Therapeutics Secures FDA Fast Track for Brepocitinib and Begins Phase 3 Study

 Time to read: 00: 32 minutes
 
Published on MedED: 21 October 2024
Originally published: 23 September 2024 
Source: PR Newswire

Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDO008
Category: Opthalmology
Crossreference: Gene Therapy
Category tags:
on-anterior non-infectious uveitis (NIU). TYK2 and JAK1

Top
 
Product Category        Product Name Company Status

Pharmaceutical

Brepocitinib

Priovant Therapeutics

Phase 3,Active
Not yet recruiting

September 23, 2024/ Press Release
 
Priovant Therapeutics has commenced the CLARITY Phase 3 study, enrolling its first patients to evaluate brepocitinib for non-anterior, non-infectious uveitis (NIU). 
 
Brepocitinib is a potential first-in-class dual selective inhibitor of TYK2 and JAK1  under evaluation for multiple highly morbid orphan autoimmune diseases. The FDA has granted it Fast Track Designation. 
 
In a previous Phase 2 study (NEPTUNE), brepocitinib showed promising results, particularly a significant treatment benefit at a dosage of 45 mg, demonstrating the highest efficacy observed for any NIU therapy to date. 
Patient-level wide-field fluorescein angiography results indicated a mean decrease in retinal vascular leakage by 4.4 points in the 45 mg group compared to a 0.5-point decrease in the 15 mg group, establishing a clinically meaningful improvement in posterior segment inflammation.

 
The CLARITY study will compare brepocitinib 45 mg to a placebo in a global multi-centre trial involving 300 subjects, randomised 1:1. 
 
The primary endpoint is the time to treatment failure, closely mirroring the successful NEPTUNE study. Key results from the NEPTUNE study, including macular oedema data, will be presented at the upcoming American Academy of Ophthalmology meeting.
 
Brepocitinib is also being evaluated in a Phase 3 study for dermatomyositis, with top-line data expected in late 2025. Priovant Therapeutics focuses on developing therapies for autoimmune diseases with limited treatment options, showcasing brepocitinib's potential to manage inflammation and improve visual outcomes in NIU patients effectively.
 


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23 September  2024,| PR Newswire | Priovant Therapeutics Announces Receipt of Fast Track Designation from FDA for Brepocitinib in Non-Anterior Non-Infectious Uveitis (NIU) & Start of Enrollment of Brepocitinib Phase 3 NIU Program
 

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