Alkeus doses first patient in Phase III NORTHSTAR trial

Alkeus Pharmaceuticals has dosed the first patient in its pivotal global Phase III NORTHSTAR study, investigating oral gildeuretinol for Stargardt disease. The primary endpoint compares atrophic lesion growth while the secondary endpoint examines preservation of visual acuity via LLVA measurement. Gildeuretinol has shown a favourable safety profile, with no reports of chromatopsia, delayed dark adaptation, or night blindness. Credit: Jo Panuwat D / Shutterstock.com. Alkeus Pharmaceuticals has dosed the first patient in its pivotal global Phase III NORTHSTAR study, investigating oral gildeuretinol (ALK-001) for Stargardt disease. The double-masked, placebo-controlled, randomised trial will assess the safety, efficacy, and pharmacokinetics of gildeuretinol…

Source: Clinical Trials Arena