ACCESS Newswire·Dec 9, 2025, 8:46 AM ET

Results from Phase 1 Multiple-Dose Study of PT00114

Protagenic Therapeutics (NASDAQ: PTIX) reported positive topline safety results from its Phase 1 Multiple Dose study of PT00114 on December 9, 2025.
PT00114 is a synthetic analogue of a naturally occurring brain peptide designed to restore homeostasis by rebalancing dysfunctional stress-response circuits.
The Phase 1 study in healthy volunteers found PT00114 was well tolerated across all dose ranges with no serious adverse events observed.
Reported adverse events were consistent with expectations for peptide-based injectable therapies, primarily injection-site reactions.
Several participants reported an improved sense of well-being, though these findings are currently anecdotal.
The company is finalizing full dataset analysis & pharmacokinetic modeling to support dose selection for future trials.
Protagenic Therapeutics expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in patients with chronic stress-related psychiatric disorders.
The Phase 2 study will target a specific patient population, with further details on design & endpoints to be released in the coming months.
The press release includes forward-looking statements regarding future filings, potential Nasdaq compliance appeals, & stock listing status.