The Current biomedical research advance towards a model in which quality and quantity of life go hand in hand. This takes on a special relevance when we talk about Develop innovative proposals For patients with diseases that lack effective medical treatments. In this context, epigenetics – the science that studies how the expression of our genes is regulated without altering DNA – is opening new therapeutic borders to treat complex diseases, such as neuropsychiatric disorders or certain types of cancer. In Oryzon we have been leading this field for more than a decade with a firm commitment to the development of differential treatments.
Our drug doubtan oral inhibitor of Epigenetic enzyme LSD1represents one of the most advanced therapeutic proposals in the field of precision psychiatry. In 2024, we completed the PHASE TEST IIB PORTICO In patients with Limit personality disorder (TLP)one of the most complex, functionally weakening and expensive psychiatric diseases for health systems, with an estimated prevalence in the general adult population between 0.5% and 5.9%, and for which there are no approved drugs.
The data showed a significant and clinically relevant reduction of aggressiveness as well as a general improvement of the disease, along with a good tolerability profile. Now we are advancing in the preparation of the study of FASE 3 Portico-2 that we will present to the United States FDA In this semester. If everything develops as we expect, Oryzon will be the only company with a clinical development drug in Phase III for TLPADwhich would represent a clinical milestone and a new horizon of hope to improve the quality of life of TLP patients and their surroundings.
But Vafidemstat’s clinical utility goes further, having shown efficacy and safety on aggressiveness also in patients with care deficit disorder and hyperactivity, autistic spectrum disorder and Alzheimer REIMAGINE y REIMAGINE-AD.
We are also evaluating Vafidemstat’s efficacy in patients with schizophrenia in the test of Fase IIb EVOLUTION. We are convinced that Vafidemstat offers great potential for the improvement of the quality of life of these patients, and consequently, also for their vital perspectives.
In parallel, our second clinical candidate, iadademstatalso inhibitor LSD1advances at a good pace in oncology. We are evaluating Iadademstat in combination with gillter In the essay of Phase IB Frida In patients with Acute myeloid leukemia (LMA) Recurpant/refractory that house a mutation of the FMS type kinase tyrosine. Also in LMAbut on the front line, we are evaluating the combination of iadademstat con venetoclax and azacitidine in two phase I trials, one of them in the framework of our Crada Agreement with the US NCI, as well as the combination with azacitidine in patients myelodysplastic syndrome in another phase I study. Within the framework of our agreement Cadawe are also evaluating Iadademstat in an I/II phase test in combination with an immune control point inhibitor in patients with small metastatic cell lung cancer on the front line.
Our Commitment to longevity, health and improvement of the quality of life Of those patients with important unresolved medical needs is Oryzon’s fundamental purpose. Through these programs, we aspire to transform the expectations of people with serious diseases, little explored or with current medicine. We do it with a Innovative approach, with a long -term vision and with the support of a team that combines clinical excellence and regulatory knowledge. We will continue to advance from the hand of the investigation and with the ambition to contribute significantly to the longevity and health of those who need it most.