Protagenic Therapeutics, a clinical-stage biopharmaceutical company, has announced two strategic partnerships to advance its lead candidate PT00114, a first-in-class investigational neuropeptide targeting the TCAP pathway for stress-related neuropsychiatric disorders including anxiety, PTSD, and treatment-resistant depression. The company 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.
Dr. Floyd brings more than 25 years of senior regulatory leadership in pharmaceutical and biopharmaceutical industries. As U.S. Head of Regulatory Affairs at Lundbeck, he led strategic regulatory activities supporting U.S. approvals of Abilify Maintena (aripiprazole extended-release injectable suspension), Trintellix (vortioxetine), and Rexulti (brexpiprazole)—three landmark CNS products spanning schizophrenia and major depressive disorder. He has also held senior regulatory roles at Novartis, Cephalon, and Axovant Sciences, and most recently served as Global Head of Regulatory Affairs at Neurogene, Inc. He serves as adjunct faculty in neuroscience at Harvard Medical School and Wake Forest University School of Medicine. As Regulatory Affairs Advisor, Dr. Floyd will lead PT00114’s regulatory strategy, including IND maintenance, pre-Phase 2 FDA meeting preparation and Phase 2 submission planning.
Protagenic’s lead asset PT00114 reported positive Phase 1 multiple-dose safety and tolerability data in December 2025, with no serious adverse events observed across dose levels. The company plans to advance PT00114 into Phase 2 clinical studies in 2026. These engagements build on recent operational and clinical milestones, including completion of the Phytanix separation in March 2026, which strengthened the company’s balance sheet by removing more than $6.3 million in liabilities and more than $1 million in annualized costs. Bill Nichols Jr., President of Protagenic Therapeutics, stated that Floyd’s “deep knowledge of FDA’s expectations in neuropsychiatric drug development is precisely what PT00114 requires as we advance toward Phase 2.”
DanforthHealth, a life science operational consulting firm that has served more than 1,800 companies, brings a flexible, scalable team of biotech professionals. The partnership will establish streamlined operational processes aligned with Protagenic’s current stage, providing access to networks spanning investors, clinical service providers and investment banks to accelerate the development trajectory. Protagenic plans to advance PT00114 into Phase 2 enrollment in 2026 with a focused team and clean capital structure.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/protagenic-therapeutics-engages-floyd-regulatory-strategic-consulting-as-regulatory-affairs-advisor-and-danforth-health-as-strategic-operations-partner