- 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.
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