Oryzon Advances to Phase III Trial for Vafidemstat in BPD
Oryzon Moves Forward with Phase III Trial for Vafidemstat
Oryzon Genomics, a prominent biopharmaceutical firm focusing on innovative therapies, is making significant strides in the clinical development of vafidemstat for the treatment of Borderline Personality Disorder (BPD). Following a constructive End-of-Phase II meeting with the FDA, Oryzon is gearing up to initiate the PORTICO-2 Phase III trial, aiming to address a critical gap in treatment options for BPD patients.
Positive Feedback from FDA
After engaging in thorough discussions with the FDA, Oryzon received encouraging feedback which validates the company’s approach in developing vafidemstat as a treatment for BPD. This meeting revolved around several key aspects of the drug's development plan, covering preclinical data, toxicology, and findings from clinical studies thus far.
Focus on Agitation-Aggression
The FDA acknowledged the potential of targeting agitation-aggression in BPD, opening the door for Oryzon to consider this condition as a possible therapeutic indication. During the meeting, the FDA expressed its agreement for Oryzon to use the STAXI-2 Trait anger scale as a primary endpoint for the upcoming Phase III study, albeit with the condition that Oryzon provides additional data to validate its clinical relevance in BPD.
Expected Trial Design
The PORTICO-2 trial is projected to enroll around 350 patients, randomly assigned to receive either vafidemstat or a placebo, over an 18-week trial duration. Oryzon also plans to conduct a qualitative research study among a subset of participants in PORTICO-2 to strengthen the validation of their chosen efficacy endpoints.
Implications for BPD Treatment
BPD is a complex and debilitating mental health condition that currently lacks any FDA-approved treatment options. With an estimated 1.4 million patients in the U.S. alone relying on off-label medications to manage symptoms, the need for a targeted therapeutic solution is clear. As Oryzon advances its clinical program, vafidemstat presents an opportunity to significantly improve the standard of care for these patients.
Company Leadership's Insights
Oryzon’s CEO, Carlos Buesa, expressed optimism regarding the FDA’s feedback stating, "We have gathered a vast amount of data on vafidemstat's neurological effects and are excited to move forward in our clinical studies. Vafidemstat is clinically promising, demonstrating safety and tolerability along with significant outcomes in reducing agitation and aggression in prior trials. This is a pivotal moment for Oryzon as we aim to alter the treatment landscape for BPD effectively.”
Preparing for Phase III and Future Steps
With the FDA’s approval, Oryzon plans to finalize the protocol for the PORTICO-2 Phase III trial and also engage with European regulatory agencies to review the plans before the trial launch. This proactive approach reflects Oryzon's commitment to expediting the development of vafidemstat.
Conference Call and Public Engagement
Today, Oryzon is hosting a conference call to share insights from the End-of-Phase II meeting and discuss future strategies with investors and the public. This transparent engagement is integral for maintaining stakeholder confidence and building momentum for the upcoming trial.
Frequently Asked Questions
What is the purpose of the PORTICO-2 trial?
The PORTICO-2 trial aims to evaluate the efficacy and safety of vafidemstat in treating Borderline Personality Disorder, specifically targeting agitation-aggression.
How many patients will be involved in the trial?
The trial is expected to enroll approximately 350 patients who will be randomized between vafidemstat and a placebo group.
What is vafidemstat?
Vafidemstat is an oral CNS-optimized LSD1 inhibitor designed to reduce cognitive impairment and neuroinflammation while providing neuroprotective effects.
Are there any approved treatments for BPD currently?
No, there are currently no FDA-approved treatments specifically for Borderline Personality Disorder.
Who can I contact for more information about Oryzon?
For more information, you can reach out to Emili Torrell at Oryzon, or contact the Investor Relations team at LifeSci Advisors.
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