Therapeutics

Revolutionizing Care: RetinalGeniX DNA/RNA GPS™ for Progressive Therapeutic Solutions in Ophthalmology and Beyond

RetinalGeniX DNA/RNA GPS™

Utilizing high-resolution retinal imaging and pharmacogenetic mapping, our solution validates and steers the creation of innovative methods and therapeutic solutions for tackling sight-threatening and various systemic diseases. It stands as the sole platform capable of screening, monitoring, and generating data for profiling, identifying trends, and establishing diagnostic indicators for both systemic and retinal disorders. The development process encompasses a non-invasive, economical assessment of patient disease risk through DNA and RNA biomarkers, enhancing drug selection, evaluation, and approval processes. This platform also presents the potential to extend initial diagnostic procedures from specialized labs and hospitals to primary care facilities, thereby increasing patient accessibility and enabling more cost-effective research endeavors.

Progressively improving for a better world.

Problem

The medical field grapples with the need for enhanced, safer, and quicker processes in Drug Validation, Drug Efficacy, and Drug Safety, along with efficient data collection and reporting of adverse drug reactions.

Solution
Advancements in Drug Development
Goal: Optimal Drug Selection, Analysis, and Validation

Drug Validation:
This process enables the development and/or reassessment of various targeted drug therapies, both existing and novel, for their most effective application.

Drug Efficacy:
Utilizing high-resolution retinal imaging, this approach validates biomarkers, thereby establishing a direct correlation between drug therapeutics and their effectiveness. Furthermore, it involves removing retinal image markers to solidify the evidence of drug efficacy.

Drug Safety:
An enhanced procedure is implemented to diagnose and monitor patients’ health via high-resolution retinal imaging and genetic mapping, ensuring safer drug administration and patient care.

Approach: Expanding Drug Portfolio and Exploring New Applications

Pharmacogenetic mapping serves as a pivotal tool in the development and reallocation of existing drug therapies, potentially effective for treating genetically similar but diverse systemic diseases. This method of “drug repositioning” leads to reduced development costs and risk assessments, given the pre-established efficacy and safety of the original drugs by regulatory authorities. The system also enables rapid and timely data collection for immediate analysis and the reporting of adverse drug reactions.

“Pharmacogenetic mapping revolutionizes drug development.”

“Administering ineffective treatments is not only costly to the healthcare system, insurance carriers, and patients, but may also cause discomfort, stress, and unnecessary risk. Developing a simple blood test that can predict the likelihood of treatment success would greatly benefit everyone involved. Advancements in pharmacogenetic mapping, provide a basis for validation and safety of Anti-VEGF therapy and an enhancement of precision medicine."
Jerry Katzman, MD
Chairman, President & CEO

Age-Related Macular Degeneration (AMD)

Problem

200 million people worldwide are estimated to have AMD as of 2022, and by 2024, this number is projected to be ~300 million1.

There are no FDA-approved drugs to prophylactically treat or stop dry AMD from progressing to wet AMD2.

Currently, no drugs approved by the FDA can prevent the dry form of this eye disease from progressing to the wet form or treat the wet form, except through intraocular injections. These direct injections into the eyes are a heavy burden on the patient, both financially and emotionally, and must be administered monthly for the rest of their life.

Solution
RTG 2023 Clinical Study

Drug candidate RTG-2023 is being developed to treat dry age-related macular degeneration (AMD). There are two forms of the disease; wet AMD and dry AMD. Wet macular degeneration is the leading cause of permanent central vision loss. Dry AMD can progress to the wet type if not monitored closely by a doctor.

The study aims to offer recommendations for enhancing the preselection process and management of ocular injections. It is being conducted with a cohort of 490 patients currently being treated via Anti-VEGF therapy requiring ocular injections.

The proposed patient selection process has the potential to reduce the cost and improve the safety and efficacy of patient candidate selection for ocular injections. These factors represent significant challenges associated with wet macular degeneration-related vision loss.

1. MacularSociety.org; dry age-related macular degeneration.

2. Age-related macular degeneration: epidemiology, genetics, pathophysiology, diagnosis, and targeted therapy Genes Dis. 2022;9:62–79.

Alzheimer's

Problem
Seven FDA-approved solutions do not affect the underlying brain changes that cause symptoms, nor do they alter the course of the disease safely.

  • People worldwide living with dementia in 2020 reaching 78 million in 2023 and 139 million by 2050.
  • Alzheimer’s disease is the most common form of dementia and may contribute to 60–70% of cases.
  • There are 6.7 million cases in the US3.
  • In 2023, Alzheimer’s and other dementias will cost the nation $345bn, not including the value of unpaid caregiving.
  • Medicare’s total payments for health care, long-term care, and hospice care for people living with dementia are projected to increase to nearly $1 trillion in 20504.
Solution
Provisional Patent Submitted November 2023
The planned solution RTG 2024, for which a provisional patent was submitted in November 2023, represents a significant stride in addressing the profound challenge posed by Alzheimer’s disease. Alzheimer’s, as the most common form of dementia, accounts for 60–70% of dementia cases globally, with an estimated 6.7 million cases in the U.S. alone as of 2022. The alarming projection that the number of people living with dementia could reach 139 million by 2050 underscores the urgency for more effective treatments.

Currently, there are seven FDA-approved solutions for Alzheimer’s, but they primarily manage symptoms without fundamentally altering the disease’s progression or addressing the underlying brain changes. This gap in treatment efficacy highlights the need for innovative therapeutic approaches, like RTG 2024, which aims to go beyond symptomatic relief.

RTG 2024 is being developed with a focus on targeting the root causes of Alzheimer’s at a molecular and cellular level. Unlike existing treatments, this novel therapeutic approach is designed to interact with the biological pathways directly involved in the disease’s progression. By potentially modifying these pathways, RTG 2024 seeks not just to alleviate symptoms but also to slow or halt the progression of Alzheimer’s disease, offering a beacon of hope in what has been a challenging therapeutic area.

The economic impact of Alzheimer’s and related dementias, which is projected to soar to nearly $1 trillion by 2050 in Medicare payments alone, highlights the critical need for effective treatments. The introduction of RTG 2024 could not only provide substantial relief to millions of patients and their caregivers but also alleviate the immense financial strain on healthcare systems.

RTG 2024 represents a promising new frontier in Alzheimer’s treatment, aiming to address the disease’s core rather than just managing its symptoms, potentially changing the trajectory of dementia care and offering a new ray of hope for millions affected by this debilitating condition.

3. Dementia facts figures and statistics, 2022

4. ALZ.org