Alkeus doses first patient in Phase III NORTHSTAR trial

▤ Summary

Alkeus Pharmaceuticals has started dosing the first patient in its Phase III NORTHSTAR trial for oral gildeuretinol in Stargardt disease. The study will test safety, efficacy, and pharmacokinetics in a randomized, placebo-controlled design across more than 11 countries. The primary endpoint measures atrophic lesion growth, while the secondary endpoint looks at preservation of visual acuity using low-luminance visual acuity. The company says the treatment has shown a favorable safety profile in earlier studies and has received multiple FDA and EMA designations. This milestone advances a potential treatment option for a rare inherited retinal disorder with no approved therapies today.

▦ Linked Companies