Lophora, a clinical-stage CNS drug discovery company developing novel, next generation 5HT2AR therapeutics to treat psychiatric disorders, announced today that it has received approval from the European Medicines Agency (EMA) to commence a Phase I, first-in-man, randomized, placebo-controlled, single-dose escalation study for LPH-5. This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic properties of LPH-5 in healthy participants.
Lophora has received approval from the European Medicines Agency (EMA) to commence a Phase I, first-in-man, randomized, placebo-controlled, 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.
Emerging research highlights the potential of serotonin 2A receptor agonists, such as psilocybin, in treating TRD and major depressive disorder (MDD). LPH-5, with its excellent solubility, stability, and robust central nervous system exposure, builds on this promising research, showing efficacy in preclinical models of depression and TRD.
“We are excited to move forward with the clinical development of LPH-5, as it represents a new frontier in mental health treatment,” said Bo Tandrup, Lophora’s Chief Executive Officer. “With the EMA’s approval to initiate this Phase I study, we are one step closer to delivering a potentially transformative therapy for patients with depression, particularly those who have not responded to conventional treatments.”
“Low doses of LPH-5 do not trigger a psychedelic experience, but still show anti-depressant effect, so this new class of medicines can be impactful both within the emerging psychedelic treatment paradigm (paired with psychotherapy), and a traditional CNS treatment paradigm” said prof. Jesper Kristensen, Lophora’s Founder and Chief Science Officer..