As Patras Med, we firmly believe that safety is not just a requirement but a cornerstone of any responsible, successful, and above all, applicable research project. Therefore, safety has been one of the structural values upon which Project "Morphe" was built. Safety has guided every step of our design process, from the construction of our genetic circuit to the choice of administration method, ensuring a therapy that is both effective and responsible.
Throughout the development of our gene therapy, we prioritized safety on four different levels: for the patient, for our team, for the environment and for society as a whole.
To create a therapy that is both applicable and safe for the patients, we implemented multiple protective design layers in our genetic circuit:
Our system is activated only under the specific condition of pathological leptin resistance. By implementing a logical AND gate, we require two signals to be present simultaneously for activation, ensuring that the therapeutic shRNA is expressed only when truly needed.
To prevent off-target effects, our construct is strictly tissue-specific. It is expressed only in the hypothalamus, and more precisely within AgRP neurons, where leptin resistance originates. This ensures that the therapeutic effect addresses the neurological root of obesity without affecting other tissues.
We introduced an additional safeguard to avoid false activation during states of fasting, which can mimic certain aspects of leptin resistance. During fasting, a naturally upregulated microRNA binds to engineered sequences in our construct, blocking knockdown activity. This ensures that the system remains inactive under non-pathological conditions, preserving safety and specificity.
One of our top priorities was to develop a therapy that could be delivered in a way that maximizes both effectiveness and safety. We finally opted for a nasal delivery route via the olfactory nerve. This approach is:
Our commitment to safety extended beyond humans, reaching the environment as well. We aligned our work with principles of sustainable development by taking careful measures in waste management. Special attention was given to the responsible disposal of laboratory waste, preventing environmental contamination. Additionally, our team completed training on safe and sustainable lab practices to ensure correct and consistent waste disposal.
With these measures, Project "Morphe" aspires not only to develop a therapeutic solution for obesity but also to set a standard of safety-conscious, ethically grounded, and environmentally responsible research.
Working with a disease, often burdened with social stigma and misconceptions, such as obesity, required us to integrate bioethical reflection into every stage of our work. From the very beginning, our design was grounded on established ethical guidelines. Patients and experts were included in every step of the process, providing crucial feedback to ensure that our approach was not only scientifically sound but also socially sensitive and ethically aligned.
Beyond patient safety, we placed strong emphasis on the well-being of our team. Given the experimental nature of our work with potentially hazardous materials, we followed strict biosafety protocols at every stage.
In every step of the way, the safety of our members always came first.
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