Spain-based Oryzon Genomics has completed patient enrolment in the Phase IIa REIMAGINE and REIMAGINE-AD clinical trials of vafidemstat.
The REIMAGINE study recruited 30 participants suffering from borderline personality disorder (BPD), attention deficit and hyperactivity disorder (ADHD), or autism spectrum disorder (ASD).
Meanwhile, REIMAGINE-AD enrolled 12 Alzheimer’s disease patients.
Vafidemstat is an oral, brain penetrant designed to specifically inhibit lysine-specific demethylase 1 (LSD1) and monoamine oxidase B (MAO-B).
Oryzon Genomics said that the drug works to mitigate cognitive impairment, including memory loss and neuroinflammation, and also exhibits neuroprotective effects.
Testing in mice for accelerated ageing and Alzheimer’s disease showed that vafidemstat could restore memory, as well as minimise the exacerbated aggressiveness to normal levels.
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The therapeutic is also said to reduce social avoidance and enhance sociability in murine models.
In the eight-week, basket REIMAGINE study, vafidemstat’s safety, tolerability, and efficacy is being assessed for addressing aggression in 11 BPD, 12 ADHD, and seven ASD patients.
The trial is being performed at the Vall d’Hebrón hospital in Barcelona, Spain, and is reported to have yielded positive preliminary efficacy results in six patient BPD and ADHD cohorts.
The eight-week REIMAGINE-AD trial is evaluating the drug for aggression in moderate Alzheimer’s patients. It is being conducted at the Fundació ACE in Barcelona.
Oryzon Genomics medical director Dr Roger Bullock said: “Aggression is a very debilitating feature across different CNS diseases, often associated with accelerated speed of progression of that CNS disorder.
“Current anti-psychotics have limited activity and are associated with serious adverse effects including sedation, cerebrovascular accidents, and increased mortality. Vafidemstat could provide a safer alternative therapeutic option for these patient groups if we continue to get positive results in these ongoing trials.”
The drug is being further studied in Phase IIa SATEEN trial for relapse-remitting and secondary progressive multiple sclerosis (MS) and Phase IIa ETHERAL study involving mild to moderate Alzheimer’s.