Clinical Trials of First-in-Class Peptide to Commence in 1H 2021

NEW YORK, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Protagenic Therapeutics, Inc. (OTCQB: PTIX) announced today that Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital (MGH), and Director of the Division of Clinical Research of the MGH Research Institute, will serve as the principal investigator in its upcoming clinical trial, a Phase 1/2a basket study designed to test PT00114 in healthy volunteers and patients with PTSD, Anxiety and Depression. PT00114 – Protagenic’s lead drug compound – is known scientifically as teneurin C-terminal associated peptide (TCAP), a naturally occurring peptide responsible for regulation of stress response in the brain. PT00114 is a first-in-class compound, and has demonstrated compelling efficacy potential with a strong safety profile in extensive preclinical models.

“PT00114 has a unique mechanism of action, with robust effects in preclinical studies. Given the critical role stress plays in Post-Traumatic Stress Disorder, Major Depressive Disorder, and Generalized Anxiety Disorder – coupled with the need to develop new therapeutic options for these patients – it is our hope that PT00114 will emerge as a new medicine for these conditions,” said Dr. Fava.

“We are looking forward to working with Dr. Fava as our principal investigator,” said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics, “Dr. Fava’s extensive experience with patients with these disorders has provided valuable insight into our clinical trial design and protocol planning.”

In addition, Protagenic Therapeutics recently completed a two-species GLP toxicology study as part of the company’s progress toward an IND filing with the FDA. PT00114 produced no observable signs of toxicity at four weeks post-injection in both a rat and non-human primate.

Beyond these key R&D progress milestones, Protagenic has continued to uncover important research validation of the science behind TCAP. A CRISPR-based gene knockdown experiment conducted last year confirmed PT00114’s activity on the Latrophilin receptor system in the brain; Latrophilins are highly conserved G-coupled protein receptors on cell surfaces responsible for receiving and transmitting messages. Understanding this cellular level mechanism of TCAP will allow Protagenic to drive more effective future development and pharmacology efforts. Moreover, PT00114 is being developed as a therapeutic for anxiety, depression, post-traumatic stress disorder (PTSD) and addiction, each of which have been shown to be associated with impaired glucose metabolism in the brain. In a recent publication (Hogg, et al¹), it was demonstrated that pharmacologically administered synthetic TCAP increases glucose uptake in brain neurons. Since glucose is the principal energy fuel for brain function, this suggests that administered TCAP has the potential to restore disordered nerve function in settings such as depression where it has been found to be deficient. Additional prior studies indicate that TCAP and the teneurins family of peptides have evolved over millennia across many different animal species, supporting the notion that these peptides play critical roles in intercellular communication in the brain.