Protagenic Therapeutics Inc (PTIX) News & EventsPTIXNews & EventsProtagenic Therapeutics Inc

Protagenic Therapeutics Receives Positive FDA Feedback on PT00114

Protagenic Therapeutics announced that it has received written responses from the U.S. Food and Drug Administration, FDA, to its Type B pre-Investigational New Drug, pre-IND, meeting request for PT00114, the Company's leading investigational neuropeptide product candidate, for the treatment of generalized anxiety disorder, GAD. In its written responses, FDA identified no clinical hold issues and raised no objection to the overall design of the Company's planned three-part Phase 1 program, including its dose-escalation approach and safety review governance, and did not identify deficiencies that it indicated would preclude submission of an IND. FDA also indicated that the Company's proposed potency and comparability strategy, together with its chemistry, manufacturing, and controls and nonclinical packages, appear reasonable to support an IND submission.

Protagenic Publishes New Preclinical Data for PT00114

Protagenic Therapeutics announced the publication of new preclinical data for its lead candidate, PT00114, in the peer-reviewed journal Behavioural Pharmacology. In a well-established rodent model of chronic unpredictable stress, PT00114 reduced both physiological and behavioral markers of chronic stress after stress had been established, while the prototypical non-peptide corticotropin-releasing factor receptor 1 antagonist CP-154,526 did not show activity on the same endpoints. As part of their pre-clinical investigation program, using a 14-day chronic unpredictable stress paradigm in male Sprague Dawley rats, the researchers evaluated PT00114 against saline as a control and CP-154,526 as a comparator. PT00114 reduced stress-induced plasma corticosterone by 56.4%, relative to stressed, saline-treated controls, after two 250 nmol/kg doses administered subcutaneously on days 12 and 13. PT00114 increased time spent in the center of an open field arena by 282% versus controls. There was no significant change in total distance traveled-indicating that the effect was not attributable to a general change in locomotion. CP-154,526 did not affect either corticosterone or time spent in the center of the open field whether it was administered on days 12 and 13 or daily throughout the entire stress paradigm These data provide further preclinical rationale for Protagenic Therapeutic's development strategy of evaluating PT00114 for the potential treatment of chronic, stress-related conditions. Protagenic has reported positive topline safety results from Phase 1 studies of PT00114 and plans to initiate subsequent clinical studies in 2027. Multiple, structurally distinct CRF1 receptor antagonists have shown robust activity in acute-stress rodent models over the past two decades but have repeatedly failed to separate from placebo in clinical trials for generalized anxiety disorder, major depressive disorder, and related conditions. The study authors note that this preclinical-to-clinical gap has been attributed, in part, to an over-reliance on acute-stress models that may not reflect the sustained, heterogeneous nature of human anxiety and depression. In this study, PT00114 retained activity while a CRF1 antagonist was ineffective in a chronic stress environment even with continuous dosing.

Protagenic Therapeutics Engages Floyd Consulting and DanforthHealth to Advance PT00114

Protagenic Therapeutics announced two strategic engagements to support the advancement of its lead candidate, PT00114. The Company has engaged Floyd Regulatory Strategic Consulting, led by regulatory affairs veteran Dr. Eric Floyd, Ph.D., MBA, as Regulatory Affairs Advisor, and DanforthHealth to establish institutional-grade operational processes and infrastructure. "Together, these engagements reflect Protagenic's deliberate, lean operating model concentrating resources and expertise on PT00114's Phase 2 advancement while positioning the Company for long-term value creation for patients and shareholders," the company said.