How are energy investors positioned?
- Information about Protagenic Therapeutics completing first dose injection for all subjects in a multiple-dose Phase 1 trial
- Timeline expectations for completing dosing and receiving data
- Plans for Phase 2 trials
- Basic information about the drug PT00114 and its mechanism
- Company information
This appears to be sufficient factual content to create a news article. I’ll proceed with writing it.
Protagenic completes first dose in PT00114 multiple-dose trial
NEW YORK - Protagenic Therapeutics, Inc. (NASDAQ:PTIX) announced Thursday it has completed the first dose injection for all study subjects in the multiple-dose portion of its Phase 1 clinical trial of PT00114, its neuro-active peptide therapy.
The biopharmaceutical company expects to complete all dosing by the end of August, with topline safety data anticipated by the end of September. These results will support advancement into Phase 2 efficacy studies planned for the first quarter of 2026. InvestingPro analysis shows the company maintains a strong cash position relative to debt, though it currently receives a weak overall Financial Health Score of 1.13 out of 10.
PT00114 is based on Teneurin C-terminus Associated Peptide (TCAP), a naturally occurring brain hormone found in the amygdala and hippocampus that regulates stress and emotional balance. The 41-amino-acid synthetic peptide is being developed to treat various neuropsychiatric conditions including anxiety, depression, addiction, and Post Traumatic Stress Disorder. The company’s development efforts come amid challenging market conditions, with InvestingPro data showing the stock has declined nearly 80% over the past year. InvestingPro subscribers have access to 8 additional key insights about PTIX’s financial health and market performance.
"Initiating the multiple-dose trial of PT00114 marks a pivotal step in our clinical program," said Robert Stein, Chief Medical Officer at Protagenic Therapeutics, according to the company’s press release.
The current multiple-dose study follows a single ascending dose trial that demonstrated PT00114’s safety and tolerability profile. The company states that unlike existing therapies that focus on symptom management, PT00114 is designed to modulate the brain’s maladaptive responses to stress.
Protagenic Therapeutics is focused on developing neuro-active peptides into therapeutics for stress-related disorders. The information in this article is based on a company press release.
In other recent news, Protagenic Therapeutics, Inc. announced a significant restructuring plan, transitioning to a virtual operating model and reducing its workforce. The company is focusing resources on its lead clinical program while temporarily suspending spending on preclinical programs and exploring strategic alternatives for these assets. In financial developments, Protagenic has raised $3.1 million through warrant exchanges and exercises, which will support its working capital and drug development efforts. Additionally, the Japanese Patent Office granted Protagenic a patent for a modified stilbenoid compound intended for epilepsy treatment, effective until March 31, 2041. This patent provides exclusivity for specific compounds and formulations. In governance updates, Timothy R. Wright has been appointed as an independent director on the board, increasing the number of independent directors to three. These developments reflect Protagenic’s ongoing strategic initiatives and resource management.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.