Lophora Submits Clinical Trial Authorisation (CTA) Application to the French Medicines Agency (ANSM) for lead CNS drug LPH-5.

Lophora, a clinical-stage CNS drug discovery company developing novel, next generation 5HT2ARA medicines to treat a multitude of psychiatric disorders, announced today that it has submitted a Clinical Trial Application (CTA) for its lead drug program LPH-5. The CTA is directed towards a Phase I first-in-human study to assess the safety, tolerability, pharmacokinetics and potential pharmacodynamic profile of LPH-5.

“This study marks a significant step towards advancing our understanding of this exciting, new class of CNS medicines. With convincing data and strong, granted composition of matter patents Lophora is well positioned to advance not only LPH-5 but also our second candidate LPH-48, a short-acting 5HT2ARA medicine to treat a multitude of psychiatric disorders” said Bo Tandrup, Lophora’s Chief Executive Officer.

“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.


About LPH-5

LPH-5 is a novel phenethylamine-derived therapeutic drug candidate demonstrating high selectivity for the Serotonin 2A receptor and excellent drug-like properties. As a true NCE, LPH-5 is neither a prodrug nor a close analog of any known psychedelics. Inspired by scientific research into the phenethylamine class, LPH-5 is an improvement over the classic Serotonin 2A receptor agonists, synthetically designed to remove problematic characteristics of the known compound classes.

LPH-5 is a potent Serotonin 2A receptor agonist and has demonstrated in vivo target engagement and persistent anti-depressant effects in rodents following a single administration. Importantly, LPH-5 demonstrates very low activity at the Serotonin 2B receptor (an off-target homolog which is implicated in heart valve disease) and has successfully cleared GLP-toxicology studies without issues.


About LPH-48

LPH-48 is a shorter acting direct analog of LPH-5 with similar optimized characteristics and safety profile, but with a shorter duration of action. LPH-48 is designed as a fast-follower that shows significantly faster metabolism, indicating a shorter duration of action in man. LPH-48 is a representative of the same proprietary compound class as LPH-5 and is therefore endowed with the same optimized characteristics including favorable drug-like properties and a safe pharmacological profile.

About lophora

Lophora is a clinical-stage CNS drug discovery company developing novel, next-generation psychedelic medicines to treat psychiatric disorders. Originating from research from the University of Copenhagen, Lophora was founded in 2018 and funded by the BioInnovation Institute (Novo Nordisk Foundation), EIFO, Innovation Fund Denmark and private investors.