Stress, anxiety, depression and inattention typically involve neuronal overactivation in several regions of the brain. Cognigenics gene therapies are designed to alleviate neuronal hyperactivity in order to foster healthy states of mental acuity, optimism, relaxation, clarity and focus.
THE COGNIGENICS APPROACH
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a revolutionary genetic technology that allows for precise editing of DNA. It functions like molecular scissors, cutting DNA at a specific location and allowing researchers to add, remove, or replace specific sections of genetic code. This technology has immense potential for treating a wide range of genetic diseases. By using CRISPR to target and modulate specific neuronal receptors known to be associated with mental health disorders, we can vastly improve overall cognitive health and wellbeing and potentially eradicate these conditions.
THE COGNIGENICS BREAKTHROUGH INNOVATION
We have successfully engineered a way to noninvasively overcome one of the primary challenges in transporting CRISPR’s molecular cargo through the blood brain barrier. Our intranasal delivery is an important development because other genetic treatments for neurodegenerative diseases typically inject the cargo directly into the brain through a hole drilled through the skull, or the cargo is delivered intravenously.
The neurotransmitters we aim to modulate, which are implicated in multiple mental health disorders, and located in specific areas of the brain, have previously been difficult or impossible to target noninvasively. Our patent-pending technology solves this problem.
THE COGNIGENICS PLATFORM
Our delivery platform has the potential to treat many mental health conditions. The cargo delivered by the platform can be customized depending on what indication or trait we wish to modulate.
The platform consists of selecting variables from each of the following areas:
- Delivery Method
Intranasal CRISPR cargo via AAV
- Types of Edits
DNA or RNA
Multiple neuronal receptors
Anxiety, depression, and cognitive impairment
- Brain Regions
Specific regions of the brain can be targeted
STRENGTHS OF THE COGNIGENICS APPROACH
- Straightforward mechanism of action
- Precise targeting of neuronal receptors
- No discernable measurable side effects in mice
- Process supported by existing neuroanatomical and neuroscience
- Lower R&D costs and faster development by leveraging selected CROs to conduct laboratory work
SHORTCOMINGS OF EXISTING THERAPIES
The anxiolytic and antidepressant drug market relies mainly on pharmaceutical products that are over 30 years old, presenting an opportunity for innovation. In addition, the efficacy of current SSRI medications, such as Prozac, Celexa, and Zoloft, are limited and have serious side effects. There is a demand for new and improved solutions that can treat anxiety and depression more effectively, presenting an opportunity for disruption and innovation in the market.
- Research shows that 30% to 50% of patients with anxiety disorder or major depressive disorder (MDD) do not respond adequately using SSRIs.
- Patients with anxiety and depressive disorders can experience relapse rates of 50% to 80% over several years depending on their treatment.
- Long-term benzodiazepine use can cause drug dependence, and the side effects of SSRIs include sexual dysfunction, chronic nausea, compromised digestive function, dry mouth, weight gain, sleep disturbances, and in serious cases, suicide.
COGNIGENICS PROGRAM OVERVIEW
Cognigenics gene therapies target specific types of neuronal hyperactivity in the brain to alleviatetraits associated with, anxiety and depression.
In 2020, our company initiated preclinical research studies. With plans to initiate clinical trials in 2024, we are on schedule to meet regulatory milestones and expect to bring our product to market as early as 2025. This timeline is in line with industry standards and allows us to rigorously evaluate the safety and efficacy of our drug candidate.