Lophora ApS, a Danish biotech company focused on next-generation psychedelic therapies for central nervous system disorders, today announced that the first subjects have been successfully dosed in the Phase 1 clinical trial of its lead candidate, LPH-5, a novel serotonergic compound.
The ongoing study is being conducted in healthy volunteers at Biotrial in Rennes, France, a leading global clinical research organization. The trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of LPH-5.
A preliminary data review is scheduled for June 17, 2025, to evaluate safety as well as initial pharmacokinetic and pharmacodynamic trends following the completion of the first dosing cohort.
Bo Tandrup, CEO of Lophora, commented: “This is a hugely exciting moment for Lophora. Dosing our first subjects represents not just a clinical milestone, but a validation of years of dedicated work. We believe LPH5 has the potential to make a real difference for people suffering from CNS disorders, and I couldn’t be prouder of our team and partners. We look forward to sharing early clinical data in July.”
Clément Rivoalen, Clinical Project Manager at Biotrial, added: “We are pleased to support Lophora in this important first-in-human study. The trial is progressing smoothly, and we are closely monitoring participant safety and protocol adherence.”
Jesper Kristensen, Lophora’s CSO, said: “LPH-5 represents a new generation of targeted serotonergic compounds with unique receptor selectivity. The initiation of this study is the first step in evaluating its differentiated safety and activity profile in humans.”
François Peaucelle, CEO of Biotrial, concluded: “We are proud to conduct this study with Lophora. It further strengthens Biotrial’s expertise in CNS trials—a field in which we are already widely recognized. We thank Lophora for placing their trust in our team.”
Lophora expects to complete the Phase 1 trial in Q4 2025, with topline results guiding further development in treatment-resistant depression and other neuropsychiatric conditions.