2017-02-009 - DR therapy - Topical ocular treatment for retinal neurodegeneration (DR therapy)

DR therapy

2017-02-009

A novel therapy for the early stages of DR based on neuroprotection. Non-invasive topical treatment (eye drops) reaching therapeutic concentrations in the retina.

Diabetic retinopathy (DR) is the most common complication of diabetes and remains the leading cause of blindness among workers in developed countries. With almost 15 million patients in Europe, there are no specific treatments for the early stages of the disease (ESDR) and the standard of care therapies on the market are anti-vascular endothelial growth factor (anti-VEGF) drugs. This project is based on the use of an eye drop containing small peptides to treat DR in the preclinical environment. The Diabetes and Metabolism Research Group of VHIR, led by Dr. Simó has shown that the administration of GLP-1 prevents and reverses neurodegeneration and vascular leakage, a crucial dual action in the treatment of ESDR. DPP-IV inhibitors, such as sitagliptin and saxagliptin administered in eye drops, cause a significant increase in the intraretinal content of GLP-1 and not only prevent neurodegeneration, but also reduce early microvascular alterations. Given the greater stability of DPP-IV inhibitors compared to GLP-1 inhibitors, the group decided to prioritize the clinical development of DPP-IV inhibitors, particularly sitagliptin.

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Obtain financing to develop its asset with the aim of reaching clinical phase II and licensing the technology to a more powerful pharmaceutical company that carries out the marketing strategy worldwide.

Diabetes represents a very high socioeconomic cost for health systems: in Spain, it is estimated that direct costs represent 8% of the total expenditure of the National Health System. Almost all patients with type 1 diabetes and it is estimated that 60% of patients with type 2 suffer from RD during the 20 years of development of the disease. The disease that is increasing its prevalence. It is estimated that 643 million adults will suffer from diabetes in 2030 worldwide, of which around 34.6% will also suffer from RD (93 million people) and 10.2% will suffer a visual threat due to DR (28 million people). The global diabetic retinopathy market size was valued at USD 3,086.00 million in 2020 and is projected to reach USD 10,785.50 million by 2030.

DR Patients

D-SIGHT SL has the financial support of Clave Capital, which has made an investment of € 1M with the creation of the spin-off. Q1 2025 – Bridge round of €1M (follow-on of Clave Capital current lead investor, ICF investment, Family Office of Prous Research and the Bio Angels Club). Q1 2026 – Series A round of €12-25M

Once the company's main product achieves favorable results in PhII, the asset will be transferred to a large pharmaceutical company through the sale of the company.

Regulatory pre-clinical studies successfully completed. CMC and GMP manufacturing of clinical batches successfully completed. Phase I clinical trial started in Q1 2025. Financial viability is secured until the completion of the first phase of clinical validation

Improvement of ESRD treatment Easy application, self-administered; Technical feasibility and approval of the development strategy for AEMPS; Non-invasive method without systemic adverse effects; Cost-effective thanks to reprofilling validation; Robust IP strategy

1. At present there are no current treatments for ESDR. Current dominating therapies (anti-VEGF drugs) are focused on later stages of the disease. 2. Most of the companies in the sector are mainly focused on wet age-related macular degeneration (AMD) and diabetic macular edema (DME). 3. The majority of pipeline agents still use invasive routes of administration.

2023: Spin-off creation / 2024: Preclinical regulatory studies / 2025: Phase I clinical trial / 2026 - 2028: Phase II clinical trial / 2028: License to big pharma.

The research results to be exploited by D-SIGHT are based on the VHIR family of patents with reference PCT/EP2017/060234, which protects the use of topical sitagliptin administered by the ocular route to treat retinal diseases with neurodegeneration. This family of patents is present in 22 countries: Europe, USA, Canada, China, Japan, Korea, Russia, Israel, Australia and Mexico (It is under evaluation in another 11 countries worldwide). So the IP strategy of this project covers the major countries of the DR market.

Future developments: The patent PCT/EP2017/060234 protects the use of sitagliptin administered by topical ocular route to treat other retinal diseases in which neurodegeneration plays a significant role; such as: glaucoma, age-related macular degeneration and retinitis pigmentosa.

Patents: WO2017186934A1; PCT/EP2017/060234 - Date: Nov 2nd, 2017 Status: Granted URL: https://patents.google.com/patent/WO2017186934A1/en

The inventors have solved a long-felt need in the field of ophthalmology by providing agents that, administered topically, can reach the retina and exert therein a neuroprotective effect to prevent it from early degeneration. In addition, the topical administration of these compounds by using eye drops limits their action to the eye and minimizes the local and systemic adverse effect. Competitive advantages compared to the current solutions:1. A novel therapy for the early stages of DR based on neuroprotection. 2. Non-invasive treatment without systemic side effects. 3. Topical treatment (eye drops) reaching therapeutic concentrations in the retina.