ORYZON to Present First in Human Efficacy Data with Vafidemstat at the 27th European Congress of Psychiatry in Warsaw

Oryzon Genomics, S.A.


ORYZON to Present First in Human Efficacy Data with Vafidemstat at the 27th European Congress of Psychiatry in Warsaw

Monday, April 8, 2019 8:00 AM

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.

About Oryzon

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.

About Vafidemstat

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).

FORWARD-LOOKING STATEMENTS

This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects,""anticipates,""believes,""intends,""estimates" and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon's securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

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Oryzon:

The Trout Group

ATREVIA

Emili Torrell

Thomas Hoffmann

Patricia Cobo/Idoia Revuelta

BD Director

+1 646 378 2932

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SOURCE: Oryzon Genomics, S.A.


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