Kiora Pharmaceuticals CEO Brian Strem joined Steve Darling from Proactive to share news the company's plan to broaden the clinical development of KIO-301, a treatment designed for various inherited retinal diseases.
The expansion includes initiating a Phase 2 trial which will be controlled, double-masked, randomized, and will involve an ascending dose. This trial is set to include up to 20 patients suffering from Retinitis Pigmentosa (RP), who will receive doses monthly over a span of 90 days.
Strem explained that this move is propelled by encouraging topline results from a Phase I/II clinical trial, which indicated that KIO-301 is a first-in-class small molecule with significant potential to improve vision for patients with RP, even those with extremely low vision or complete blindness.
Moreover, Kiora Pharmaceuticals has plans to engage with the FDA in the fourth quarter of 2023. The goal of this meeting is to achieve consensus regarding the study designs, endpoints, and additional requirements necessary to conduct further studies in the United States and Europe. These studies would not only target RP but also extend to other inherited retinal diseases such as Choroideremia (CHM) and Stargardt disease.