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Oryzon Genomics Gains FDA Support for Vafidemstat Phase III Trial in Borderline Personality Disorder

• Oryzon Genomics has secured FDA agreement on its Phase III clinical trial design for vafidemstat in Borderline Personality Disorder (BPD). • The planned Phase III trial will evaluate the efficacy and safety of vafidemstat in reducing BPD symptoms. • Vafidemstat, a LSD1 inhibitor, represents a potential new treatment option for BPD, addressing a significant unmet medical need. • This regulatory milestone allows Oryzon to advance vafidemstat towards potential market approval, offering hope for improved BPD management.

Oryzon Genomics has received a positive response from the FDA regarding its Phase III clinical trial plans for vafidemstat in the treatment of Borderline Personality Disorder (BPD). This agreement paves the way for Oryzon to initiate a pivotal study evaluating the drug's efficacy and safety in this challenging patient population.
Vafidemstat is a LSD1 inhibitor. The Phase III trial aims to demonstrate the clinical benefits of vafidemstat in reducing the severity of BPD symptoms. Borderline Personality Disorder is characterized by emotional dysregulation, impulsivity, and unstable relationships, significantly impacting patients' quality of life. Current treatment options are limited, highlighting the need for novel therapeutic interventions.
The successful development of vafidemstat could provide a valuable new treatment option for individuals with BPD, addressing a significant unmet medical need in mental health. The company is now positioned to move forward with the Phase III trial, a crucial step towards potential regulatory approval and commercialization of vafidemstat.
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Oryzon's Vafidemstat Receives FDA Support for Phase III Trial in Borderline Personality Disorder

Oryzon Genomics has received positive feedback from the FDA regarding its Phase II meeting for vafidemstat in Borderline Personality Disorder (BPD).
The FDA supports the initiation of a Phase III trial, acknowledging agitation-aggression in BPD as a potential therapeutic indication.

Reference News

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FDA Backs Oryzon's Phase III Plans For Borderline Personality Disorder Drug - Scrip
scrip.citeline.com · Oct 2, 2024

Article sent to my@email.address. Multiple recipients require semicolon separation. Active subscribers access full artic...

[2]
Oryzon Genomics - FDA aligns on Phase III BPD plans - Edison Investment Research
smartkarma.com · Oct 2, 2024

Try Smartkarma's AI-augmented investing platform with a free Preview Pass to unlock research summaries, follow top analy...

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