Lophora, a clinical-stage CNS drug discovery company developing novel, next generation 5HT2ARA
therapeutics to treat psychiatric disorders, is thrilled to announce that it has received approval from the
European Medicines Agency (EMA) to commence a Phase I, first-in-man, randomized, placebocontrolled,
single-dose escalation study for LPH-5. This study will investigate the safety, tolerability, pharmacokinetic,
and pharmacodynamic properties of LPH-5 in healthy participants.
This marks a significant milestone in the development of LPH-5, a highly selective small molecule agonist of the
serotonin 2A (5HT2A) receptor. Designed for use in psychedelic-assisted psychotherapy, LPH-5 offers a new
approach to treating depression and treatment-resistant depression (TRD), an area of immense unmet
medical need.
Depression affects over 350 million people worldwide, yet current treatment options are often slow to take effect
and inadequate for many patients. Only 60% of patients respond to existing antidepressants, leaving millions
without effective relief. Non-responders suffer from reduced quality of life, increased healthcare utilization, and
higher medical costs, with expenditures 29.3% greater than the general population.