PulseSight Seeks French Approval for Phase I Trial of PST-611 for Dry AMD

PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, announces it has submitted a Clinical Trial Authorization (CTA) to Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for a phase I trial (PST-611-CT1) assessing the safety and tolerability of PST-611 in humans.

PST-611-CT1 is a first-in-human single ascending dose trial aiming to confirm the favourable safety profile of the drug and validate the maximal dose for the phase II proof-of-concept study, in six to twelve dry age-related macular degeneration (AMD)/geographic atrophy (GA) patients. The study PST-611-CT1 is expected to start early Q2 2025 with a readout anticipated by the end of 2025 or early 2026.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex and involves the dysregulation of iron homeostasis, leading to an excess of free iron, which results in inflammation, oxidative stress, and cell death.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry AMD/GA, expressing human transferrin, a highly potent iron regulator, to restore normal iron homeostasis.

The PST-611-CT1 phase I trial builds on PulseSight’s previous clinical demonstration of the favourable safety profile of its electrotransfection delivery system and plasmid technology, as well as preclinical experiments demonstrating the beneficial effects of PST-611 in reducing oxidative stress and inflammation, and preserving the integrity of the retinal pigment epithelium, with the potential of preventing retinal degeneration and vision loss.

Judith Greciet, CEO of PulseSight Therapeutics said, “This first in human study is a significant milestone for the clinical development of PST-611, which we believe holds the potential to become a major new treatment option for patients with dry AMD/GA. Our goal is to confirm the safety of our drug candidate to then rapidly move into a phase II proof-of-concept study, to demonstrate transferrin’s ability to protect retinal cells from atrophy and preserve vision.”

Dirk Sauer, chairman of the board of PulseSight Therapeutics said, “This is a pivotal moment as we progress towards clinical studies with our lead programme PST-611. PST-611 has shown unique features in terms of efficacy, safety and durability of effect in a robust preclinical plan. This programme is the first milestone in the validation of our candidate’s potential to be truly life-changing for dry AMD/GA patients.

PulseSight is supported in its clinical trial execution by expert CRO ILife Consulting.

AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by Q2 2025.

PulseSight is clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.

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