Protagenic Therapeutics, Inc. announced the completion of enrollment in the single dose portion of its Phase 1 trial involving PT00114, its synthetic stress-regulating peptide, for treating neuropsychiatric disorders. This marks a significant milestone with the enrollment of 30 subjects across five cohorts, receiving doses up to 1,000 micrograms. PT00114 has demonstrated outstanding tolerability with no adverse safety findings, building upon safety validations reported earlier this year. The trial progresses as PT00114 shows potential to transform treatment for anxiety, depression, PTSD, and addiction.

Data from this safety trial phase are anticipated to be announced in May. The study also includes assessments of biomarkers including cortisol levels before and after treatment. Protagenic Therapeutics continues to lead in the development of neuro-active peptides, addressing the profound need for innovative treatments in mental health.

PT00114 is a candidate to become a therapeutic for severe neuropsychiatric conditions, mimicking the naturally occurring brain peptide TCAP to counteract stress-induced hormonal effects.