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, “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.”