Candidate: Vafidemstat (ORY-2001)
Type: Oral CNS optimized LSD1 inhibitor
Status: Oryzon said May 18 it enrolled the first patient in a Phase II clincal trial evaluating vafidemstat in seriously ill COVID-19 patients, a month after its clinical trial application (CTA) received accelerated approval from the Spanish Drug Agency (AEMPS) under urgency provisions related to the pandemic.
The Phase II study, called ESCAPE (Efficacy and Safety of a Combined treatment with vafidemstat to prevent ARDS in adult Patients with severE COVID-19) (EudraCT No.: 2020-001618-39), is an open-label, randomized, double-arm Phase II trial to assess the efficacy and tolerability of vafidemstat in combination with standard of care treatment, to prevent progression to Acute Respiratory Distress Syndrome (ARDS). The study endpoints will be assessed at days 5, 14, and 28.
Oryzon has performed a Phase IIa clinical trial evaluating vafidemstat in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe Alzheimer’s disease (REIMAGINE-AD), with positive preliminary clinical results reported. Additional Phase IIa clinical trials with vafidemstat are ongoing in patients with mild to moderate Alzheimer’s (ETHERAL), where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 months of treatment, and in Relapse-Remitting and Secondary Progressive MS (SATEEN). In animal studies vafidemstat was shown to restore memory and reduce the exacerbated aggressiveness of SAMP8 mice, to normal levels, and also reduced social avoidance and enhances sociability in murine models. In addition, vafidemstat showed fast, strong and durable efficacy in several preclinical models of multiple sclerosis.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: