Author: edgover

Paris, France, July 7^th, 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce that the first patient has been successfully dosed in its Phase I clinical trial (PST-611-CT1) aiming to assess safety and tolerability of its lead program, PST-611, in humans.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry Age-related Macular Degeneration (AMD) /Geographic Atrophy (GA), expressing human transferrin, a highly potent iron regulator, playing a central role in restoring normal iron homeostasis.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet medical need. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cell death (ferroptosis).

PST-611-CT1 is a first-in-human single ascending dose study that aims to establish, in six to a maximum of 12 dry AMD/GA patients, the safety profile of the drug and validate the maximal tolerated dose in view of the following Phase IIa proof-of-concept trial. Preliminary results are anticipated early 2026, subject to patient recruitment.

The study is being conducted in Paris and Grenoble by Professor Francine Behar-Cohen, MD, PhD at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), the inventor of our technology, and Professor Christophe Chiquet, MD, PhD at the Department of Ophthalmology, CHU Grenoble Alpes.

Professor Francine Behar-Cohen declared, “Having pioneered the development of the electro-transfection technology that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye, I am very excited to move PST-611, expressing transferrin, into its first clinical trial. Late-stage dry AMD/ GA is a progressing disease that leads to vision loss and for which we have no therapeutic options for our patients. Based on its mechanism of action and thanks to the innovative delivery technology, PST-611 has potential to become a major treatment option for these patients.”

Judith Greciet, CEO of PulseSight Therapeutics said, “The dosing of the first patient in our PST-611-CT1 trial is a very exciting milestone for the company. Supported by the previous clinical demonstration of the safety profile of our innovative delivery technology and a solid pre-clinical package, we believe PST-611 holds the potential to improve both anatomical and functional features of dry AMD/GA.  Moreover, the sustained and long-lasting expression of transferrin should help reduce the need for frequent reinjections, strongly improving patients’ compliance to the treatment. Once the safety and the maximal dose are confirmed, our goal is to swiftly move into a phase IIa proof-of-concept study, to demonstrate the ability of transferrin to protect retinal cells from atrophy and preserve vision.”

-ENDS-

 

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

 

About age-related macular degeneration (AMD)

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.

About PST-611 for GA
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 late summer 2025.

About PulseSight Therapeutics

PulseSight is a 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.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

Watch the video of the technology here: www.PulseSightTherapeutics.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/

Paris, France, 2 June 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce it has received the Clinical Trial Authorization (CTA) from the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) for a Phase I trial (PST-611-CT1) assessing PST-611 safety and tolerability in human.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD’s pathogenesis is complex, and the disease still represents a high unmet need. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cells 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, playing a central role to restore normal iron homeostasis.

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 II proof-of-concept study, in six to a maximum of twelve dry age-related macular degeneration (AMD)/geographic atrophy (GA) patients.

The study will be conducted in Paris and Grenoble by Professor @Francine Behar-Cohen, MD, PhD at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), the inventor of our technology, and Professor Christophe Chiquet, MD, PhD at the Department of Ophthalmogy, CHU Grenoble Alpes. It is expected to start later in the summer with a readout anticipated early 2026.

The PST-611-CT1 Phase I trial builds on PulseSight’s previous clinical demonstration of the favorable safety profile of its innovative delivery technology and benefits from a solid preclinical package demonstrating its potential to address both anatomical and functional features of Dry AMD/GA. Moreover, the sustained and long-lasting expression of transferrin should help reduce the need for frequent reinjections, strongly improving patients’ compliance to the treatment.

Judith Greciet, CEO of PulseSight Therapeutics said, “Congratulations to our team and consultants for their excellent work to reach this first milestone to bring PST-611 to patients. We believe PST-611 holds the potential to become a major new treatment option for patients with dry AMD/GA. Our goal is to confirm the safety and the optimal dose 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.”

-ENDS-

 

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

 

About age-related macular degeneration (AMD)
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.

About PST-611 for GA
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 late summer 2025.

About PulseSight Therapeutics

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.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/

Paris, France, 13 February 2025 – PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, today announces the first close of its Series A financing with existing investor Pureos BioVentures committing new funds to support the Phase I study of PST-611 and enable preparation for a Phase IIa clinical trial.

PST-611 is a first in class non-viral vectorized therapy for the treatment of dry age-related macular degeneration (AMD)/geographic atrophy (GA), expressing human transferrin, a highly potent iron regulator. Restoring normal iron homeostasis, transferrin has demonstrated strong beneficial effects in preclinical models, reducing oxidative stress and inflammation, and preserving the integrity of the retinal pigment epithelium, with the potential of preventing retinal degeneration and vision loss.

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.

PulseSight has already demonstrated the favorable safety profile of its innovative technology as well as biological activity in the clinic, with a previous clinical program in non-infectious uveitis.

The planned PST-611-CT1 clinical trial aims at primarily confirming the favorable safety profile of PST-611 administration and is expected to start Q2 2025, subject to the regulatory greenlight, with readout anticipated end 2025/early 2026.

The Series A financing remains open to new investors, to provide funds to support PST-611 Phase IIa clinical trial preparation and implementation, as well as the development of PulseSight’s wider portfolio of non-viral vectorized therapies including PST-809, a potential first-in-class therapy for wet AMD that comprises a dual-gene plasmid encoding for a potent anti-VEGF, together with decorin, an anti-angiogenic and anti-fibrotic native protein. Wet AMD is a complex disease involving many pathological pathways which lead to progressive vision loss and there remains a significant unmet need.

Dominik Escher, board director of PulseSight and Partner at Pureos Bioventures said, “Pureos is delighted to continue its support of PulseSight, to enable it to advance what we believe could be truly life-changing treatments for patients with diseases leading to sight loss. PST-611 is developed in GA, a blinding disease with no treatments approved in Europe. PST-611 has a completely new mode of action with the potential to stop the progression of the disease, a truly high unmet medical need. PulseSight has the innovation and expertise to become a highly valuable company in the field of non-viral gene therapy in ophthalmology.”

Judith Greciet, CEO of PulseSight Therapeutics said, “We are excited to have the funds to progress our lead program, PST-611, which we believe holds the potential to become a major new treatment option for patients with dry AMD/GA. This financing enables us to execute on our goal of confirming the safety of our drug candidate and to then rapidly move into a phase II proof-of-concept study, to demonstrate transferrin’s ability to protect retinal cells and preserve vision.”

Dirk Sauer, Chairman of the Board of PulseSight Therapeutics said, “I congratulate Judith and the team who have advanced PST-611 at pace during 2024 and welcome the continued support of Pureos BioVentures to advance our lead candidate. There remains an unaddressed need for non-viral approaches that would unlock the full potential of gene therapies. I am encouraged by the data behind PulseSight’s approach and its therapies, and I look forward to welcoming other investors to the syndicate to enable us to further validate PulseSight’s disruptive potential through clinical studies.”

 

-ENDS-

 

Media contact
Sue Charles, Charles Consultants
T: +44 (0)7968 726585
E: sue@charles-consultants.com

 

About age-related macular degeneration (AMD)
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.

About PulseSight Therapeutics
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.

Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

About PST-611 for GA
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.

Based in Paris, France the PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

ILife Consulting is a Paris-based CRO dedicated to providing tailored consultancy and CRO services to biotechs. contact@ilifeconsulting.com

Follow us on LinkedIn – https://www.linkedin.com/company/pulsesight-therapeutics/