Protagenic Therapeutics has completed first-dose injections for all participants in the multiple-dose segment of its ongoing Phase 1 clinical trial for PT00114, according to the company. Full dosing is expected to conclude by the end of August 2025, with topline safety data anticipated by the end of September 2025, the company said that this will support progression to Phase 2 efficacy studies in the first quarter of 2026.
The company claims that PT00114 is the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a naturally occurring brain hormone concentrated in the amygdala and hippocampus that regulates stress responses and emotional balance. Unlike existing treatments that blunt symptoms, the company said that PT00114 is thought to directly modulate maladaptive stress responses, offering a potentially differentiated approach to treating conditions such as anxiety, depression, addiction, and PTSD.
Following a successful single ascending dose trial that confirmed a favourable safety and tolerability profile, the company said that positive results are enabling the rapid advancement into Phase 2 trials.
