Ophthalmology biotech company PulseSight Therapeutics SAS announced it has submitted a Clinical Trial Authorization (CTA) to France’s Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for a phase 1 trial (PST-611-CT1) assessing the safety and tolerability of its therapy PST-611 in humans.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry age-related macular degeneration (dry AMD)/geographic atrophy (GA), expressing human transferrin, a highly potent iron regulator, to restore normal iron homeostasis, according to a PulseSight Therapeutics press release. PST-611-CT1 is a first-in-human single ascending dose trial aiming to confirm the favorable safety profile of the drug and validate the maximal dose for the phase 2 proof-of-concept study, in 6 to 12 dry AMD/GA patients. The company says the study PST-611-CT1 is expected to start early Q2 2025 with a readout anticipated by the end of 2025 or early 2026.

Judith Greciet, CEO of PulseSight Therapeutics, said, “This first in human study is a significant milestone for the clinical development of PST-61…Our goal is to confirm the safety of our drug candidate to then rapidly move into a phase 2 proof-of-concept study, to demonstrate transferrin’s ability to protect retinal cells from atrophy and preserve vision.”