The biopharmaceutical company Oryzon Genomics, member of CATALONIA.HEALTH, announces that it has received the official record of its recent meeting of End-of-Phase II for vafidemstaten for Personality Limit Disorder (TLP) with the US Food and Drug Administration (FDA). ORYZON will begin the preparation of a complete protocol for the study of Phase III PORTICO-2 that will soon be presented to the FDA for approval.
At the End-of-Phase II meeting with the FDA, various aspects of the vafidemstat development plan were thoroughly evaluated and discussed. The minutes of the meeting cover the FDA's opinion on the suitability of the vafidemstat program in various critical areas: preclinical data, toxicology, clinical pharmacology, and clinical studies.
Carlos Buesa, CEO of Oryzon, comments, “We are delighted with the positive result of our interactions with the FDA and with the prospect of advancing vafidemstat towards pivotal Phase III clinical studies for the TLP, an area with an important unmet medical need, as there are currently no approved drugs. Recent approvals of vafidemstat patents in the field of TLP further highlight its commercial potential. This marks a turning point for Oryzon.”.
With positive comments received after the meeting with the FDA, Oryzon will begin preparations for the Phase III programme, including the preparation of a full protocol for the Phase III PORTICO-2 test to present to the FDA. The company will also contact European regulatory agencies, following the usual practice, before starting the Phase III PORTICO-2 trial.
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