Receiving RPDD does not change the regulatory requirements for approval, but it can provide a significant advantage in terms of an expedited review timeline.
“Receiving RPDD from the FDA is a significant regulatory milestone for ConSynance as we prepare for the Phase 2 study of CSTI-500 for PWS,” said Shuang Liu, PhD, Founder and CEO of ConSynance.
CSTI-500 is a phase 2-ready, first-in-class, orally administered Triple Monoamine Reuptake Inhibitor (TRI). It is designed to optimally increase the levels of three critical neurotransmitters, serotonin, dopamine, and norepinephrine, in the synaptic clefts of neurons. CSTI-500 has demonstrated brain target engagement in healthy volunteers.
These data, along with the corresponding pharmacokinetics data, predict the efficacy of CSTI-500 in PWS and other neuropsychiatric indications. CSTI-500 has been studied in nearly 100 humans across three Phase 1 clinical trials, including 10 PWS patients, setting the stage for a Phase 2 study expected to commence in 2025.
Read Consynance's full press release here.