Efficacy data from the REIMAGINE Phase IIa basket trial’s Borderline Personality Disorder (BPD) cohort
Vafidemstat is an active compound in humans
MADRID, SPAIN and CAMBRIDGE, MA / ACCESSWIRE / April 8, 2019 / Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announces that the company will be presenting today the first human efficacy data with its CNS epigenetic drug vafidemstat. Specifically, Oryzon is presenting data from its Phase IIa clinical trial REIMAGINE at the 27th European Congress of Psychiatry (EPA 2019) in Warsaw, Poland.
The preliminary REIMAGINE results to be presented at EPA 2019 represent the Borderline Personality Disorder (BPD) cohort. Overall, vafidemstat treatment met in this cohort all the primary and secondary endpoints in the REIMAGINE trial.
As for the primary endpoint, vafidemstat was safe and well tolerated and showed a trend on improving suicidal ideation (overall decrease in the Columbia-Suicide Severity Rating Scale, p=0.08).
In terms of efficacy, after 2 months of vafidemstat treatment statistically significant findings included:
- Global improvement on the Clinical Global Impression (CGI) Severity (CGI-S) and CGI-Improvement (CGI-I) scales (p=0.011 and p=0.017, respectively)
- Global Improvement on the Neuropsychiatric Inventory (NPI) total score (p=0.018)
- Specific improvement on the NPI 4-item Agitation/Aggression subscale (p=0.004)
- Overall improvement on the Global BPD checklist (BPDCL) scale score (p=0.005)
- Specific improvement on the 3 aggression-related BPDCL domains combined score (p=0.003)
- Additional improvement on the 6 non-aggression-related BPDCL domains combined score (p=0.023)
In summary, vafidemstat showed to be an active compound and produced significant improvements across several commonly used scales that measure agitation and aggression. In addition, the significant improvements in the Total NPI score, overall BPDCL Total Score and the sub-item analyses suggest that vafidemstat has a broader psychiatric effect beyond agitation and aggression.
Dr. Carlos Buesa, CEO of the company, stated. “These results in humans are in line with the striking data previously obtained in animal models of aggression and sociability. This confirms the potential of vafidemstat to be developed in a broad range of CNS indications. The company is now studying this potential in detail”.
For more information on this event please visit https://epa-congress.org/2019#.XID8AVVKipo
For a complete view of the poster please visit https://www.oryzon.com/sites/default/files/20190408 ORYZON_EPA_ePoster_final.pdf
REIMAGINE (EudraCT Number 2018-002140-88) is a Phase IIa “basket” clinical trial to evaluate the safety, tolerability and efficacy of vafidemstat in aggression in adult population with CNS disorders, including three psychiatric disorders (BPD, Autism Spectrum Syndrome (ASD) and adult Attention Deficit Hyperactivity disorder (ADHD)). This trial includes 6 patients per indication and is being conducted in Spain at the Vall d’Hebrón hospital in Barcelona. REIMAGINE is designed as a single-arm, open-label, 8-weeks treatment study.
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds vafidemstat and iadademstat in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com
About Borderline Personality Disorder
BPD is the most frequent personality disorder. It is estimated that its prevalence ranges from 0.5% to 1.4% in the general population, between 11% and 20% in outpatients, between 18% and 32% in patients hospitalized in psychiatric units and between 25% and 50% in prison inmates. BPD is one of the most complex, functionally debilitating and costly psychiatric conditions currently facing the mental health systems. Patients with BPD typically experience emotional instability, impulsivity, irrational beliefs and distorted perception, as well as intense but unstable relationships with others. Up to 10% of people affected die by suicide. Women are diagnosed about three times as often as men. It is a significant unmet medical need. There are currently no approved drugs by the FDA to specifically treat BPD.
Vafidemstat (ORY-2001) is an oral, brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease, to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Vafidemstat is in Phase IIa clinical studies in patients with Relapse-Remitting and Secondary Progressive MS (SATEEN), in patients with Mild to Moderate Alzheimer’s disease (ETHERAL) and in aggressiveness in patients with different psychiatric or neurodegenerative disorders (REIMAGINE, a basket trial).
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SOURCE: Oryzon Genomics, S.A.
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