Privosegtor
What is being evaluated in the PIONEER program?
Privosegtor is a novel investigational drug candidate with potential neuroprotective properties for neuro-axonal diseases. It is a peptoid small molecule that crosses the blood brain and retinal barriers.
Positive results from the Phase 2 ACUITY trial showed Privosegtor’s neuroprotective potential through reduction of neurofilaments, a surrogate biomarker for neuro-axonal damage, anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis.2
The goal of the registrational PIONEER-1 and PIONEER-2 trials is to further evaluate the safety and efficacy profile of Privosegtor in treating adults with optic neuritis.
The PIONEER 1 clinical trial of Privosegtor has been reviewed and approved by an Institutional Review Board (IRB) in the United States or by independent Ethics Committees (ECs) in other participating countries.
This review ensures that the rights, safety, and welfare of trial participants are protected.
The PIONEER 2 clinical trial will also undergo review and approval by an Institutional Review Board (IRB) in the United States or by independent Ethics Committees (ECs) in other participating countries, prior to enrolling any participants.
Note: IRB approval focuses on participant protections and ethical conduct. It does not mean the investigational product is approved by the FDA or other Health Authorities or proven safe or effective.
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Privosegtor is an investigational drug candidate and has not been approved by the FDA. Safety and efficacy of Privosegtor for optic neuritis have not been established.
References
1. Villoslada P, et al. Neurotherapeutics. 2019;16(3):808-827 2. ACUITY trial results presented by Sophie Bonnin, MD at EURETINA 2025 in the late-breaking session: “Improved Low Contrast Visual Acuity and Reduction in Retinal Ganglion Cell Loss with Privosegtor in Acute Optic Neuritis: Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial”.