PulseSight Therapeutics SAS, an ophthalmology biotech company, today launches with seed finance from Pureos Bioventures and ND Capital.
It’s poised to clinically validate its delivery platform by advancing two first-in-class late-stage preclinical drugs for wet and dry age-related macular diseases (AMD) including geographic atrophy (GA), major diseases of the elderly leading to blindness.
PulseSight’s proprietary non-viral gene therapy ocular platform uses an electro-transfection system to deliver DNA plasmids, encoding therapeutic proteins into the ciliary muscle to treat major eye diseases.
The technology has already been validated in a first Phase I/II clinical study, demonstrating a good safety profile of both the plasmid and the delivery system, as well as a long-lasting clinical benefit up to eight months (in patients with chronic noninfectious uveitis).
Current treatments for wet AMD all belong to the same class of drugs that target vascular endothelial growth factor (VEGF) and act primarily on the neovessels to reduce vascular leakage.
These drugs offer a limited efficacy over time, leading to the need for frequent reinjections.
Wet AMD is a complex disease involving many pathological pathways which lead to progressive vision loss and there remains a significant unmet need.
PST-809 for wet AMD
The company’s lead program, PST-809 is a potential first-in-class therapy for wet AMD that comprises a dual-gene plasmid encoding for a potent anti-VEGF, aflibercept, together with decorin, an anti-angiogenic and anti-fibrotic native protein that reduces choroidal neovascularisation (CNV), vascular leakage and subretinal fibrosis preventing the epithelial mesenchymal transition of the retinal pigment epithelial (RPE) cells or even favouring RPE healing.
In preclinical studies, PST-809 has shown superior efficacy to intravitreal aflibercept to reduce vascular leakage and to promote RPE wounds healing, indicating its potential to promote disease regression and durably prevent vision loss in patients. PST-809 also holds the potential to improve compliance by reducing the need for repeated anti-VEGF injections to one injection every six months, alleviating the burden of treatment for this chronic disease.
PST-611 for GA
The second program, PST-611 for geographic atrophy (GA), in late-stage dry AMD uses the same disruptive delivery technology with a plasmid that encodes the human transferrin protein, a natural iron transporter involved in the control of iron levels in the eye.
PST-611 holds the potential to effectively address many of complex pathophysiological pathways involved in GA/dry AMD whilst also benefiting from the need for re-treatment only every six months.
Preclinical experiments of PST-611 conducted across various disease models show the beneficial effects of transferrin to remove iron, reduce oxidative stress, preserve the integrity of the retinal pigment epithelium and prevent retinal degeneration and vision loss.
In addition to GA, PST-611 has upside for the potential treatment of other neurodegenerative retinal disorders such as glaucoma or retinitis pigmentosa for which PST-611 has been awarded orphan drug designation by the FDA and EMA.
The company has an experienced leadership team led by newly appointed pharma-biotech experienced CEO Judith Greciet PharmD. She brings over three decades of experience in the pharma and biotech industries, notably as CEO of Onxeo and as President of Eisai France.
She joins skilled professionals specialiaed in ophthalmology, gene therapy, device and drug development, including Thierry Bordet, PhD as CSO.
Judith Greciet, CEO of PulseSight Therapeutics said, “I am excited to join the company with a validated and highly differentiating delivery platform and two non-viral gene therapy programs at late preclinical stage. Our proprietary non-viral gene therapy approach provides unique features in terms of efficacy, safety and durability of effect.”