Protagenic Therapeutics To Start Clinical Trials For Depression Candidate By 2021 End

Upon reviewing Protagenic Therapeutics Inc's PTIX Investigational New Drug (IND) application for its lead compound, PT00114, the FDA has currently rejected the Company's IND.
The application sought approval to start a Phase 1/2a basket study designed to test PT00114 in healthy volunteers and patients with PTSD, anxiety, and depression.
The agency has asked the Company to provide clinical sites with ready-to-inject clinical vials rather than providing site pharmacies with drug substances to be formulated locally.
Protagenic is immediately implementing the necessary change; hence it expects to refile its IND and commence patient enrollment in Q4 of 2021 against 1H of 2021.
In April, the Company closed NASDAQ uplisting and a $13.2 million public offering.
PT00114 is a teneurin C-terminal associated peptide (TCAP), a naturally occurring peptide responsible for regulating stress response in the brain.
Price Action: PTIX shares closed at $2.46 on Friday.
Related content: Benzinga's Full FDA Calendar.