ORYZON Presents Efficacy Data From its Two Vafidemstat Clinical Trials in Alzheimer’s Disease at the Virtual AAT-AD/PD 2020 Conference

•   REIMAGINE-AD:

• Significant reduction of Agitation-Aggression after 6 months of treatment
• Significant improvement in caregiver-burden
• Safe and well tolerated

•   ETHERAL-EU 6 month data:

• Primary endpoint met: safe and well tolerated
• Some inflammatory and neuronal-damage biomarkers reduced
• AD patients do not show cognitive improvement after 6 months of treatment

MADRID, Spain and CAMBRIDGE, Mass., April 03, 2020 (GLOBE NEWSWIRE) -- 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 it will present safety and efficacy data from its two vafidemstat clinical trials in Alzheimer’s disease (AD), REIMAGINE-AD and ETHERAL, at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD 2020 meeting, to be held April 2-5, 2020. This meeting, originally scheduled to take place in Vienna, Austria, will now be held in an entirely virtual format due to the Covid-19 pandemic.

REIMAGINE-AD is a Phase IIa study to assess the effect of vafidemstat in agitation-aggression in moderate and severe AD patients. The company is presenting a written communication (electronic poster) entitled “VAFIDEMSTAT SAFETY AND EFFICACY IN ALZHEIMER-RELATED AGITATION & AGGRESSION: PHASE II REIMAGINE-AD 6-MONTH DATA”. Following are the main findings reported in this e-poster.

Twelve patients were recruited and treated for 2, 4, or 6 months with vafidemstat (1.2 mg). The drug was safe and well tolerated. Treatment also showed a significant statistical clinical improvement in the diverse clinical scales used in the study. Data were analyzed with the one-tail repeated-measures Wilcoxon signed-rank test to compare cognitive/behavioral scores on visit 1 (or screening) and visit 8 (6 month treatment). Findings after six months of vafidemstat treatment included:

• Statistically significant reduction of aggression as measured by the Clinical Global Impression of Improvement (CGI-I) scale (p<0.05).
• Statistically significant reduction of aggression measured by the Cohen-Mansfield Agitation Inventory (CMAI) scale (p<0.05).
• Statistically significant reduction of aggression measured by the Neuropsychiatric Inventory (NPI) 4-item Agitation/Aggression subscale (p<0.05).
• Statistically significant global improvement on the NPI total score (p<0.05).
• Statistically significant global improvement on the caregiver burden as measured by the Zarit Caregiver Burden Interview (ZBI) scale (p<0.05).

Of note, the behavioral improvements in this AD population required longer treatment times than previously reported in the younger psychiatric populations in the original REIMAGINE trial. Regarding efficacy measurements that evaluated memory, the memory/cognitive capabilities measured by the MMSE showed a statistically significant improvement across the 11 patients completing 2 months of treatment (p<0.05), with 7 patients improving their MMSE, 3 with stable scores and 1 worsening. However, this improvement was not maintained at 4 and 6 months. Nevertheless, two out of four moderate patients consistently scored significantly better at months 4 and 6. On the basis of this anecdotal observation, the treatment in these two patients has been extended to 12 months to further investigate this finding.