#Protagenic Therapeutics Engages Key Partners for PT00114 Advancement
Protagenic Therapeutics, Inc., a New York-based biopharmaceutical firm focused on innovative peptide therapies for neuropsychiatric disorders, announced significant strategic partnerships to support its lead development candidate, PT00114. The company has enlisted Floyd Regulatory Strategic Consulting and Danforth Health to enhance its regulatory affairs and operational infrastructure.
Dr. Eric Floyd, Ph.D., MBA, a seasoned regulatory affairs expert, has been appointed Regulatory Affairs Advisor. Dr. Floyd's credentials include over 25 years of experience in the pharmaceutical sector, particularly in guiding central nervous system (CNS) developments. His previous work includes leading regulatory activities for major CNS products at Lundbeck, which received U.S. approvals for notable treatments such as Abilify Maintena ®, Trintellix ®, and Rexulti ®.
In his new role, Dr. Floyd will oversee Protagenic's regulatory strategy for PT00114, which includes maintaining the Investigational New Drug (IND) status, preparing for a pre-Phase 2 meeting with the FDA, and planning the upcoming Phase 2 submission. His extensive background in CNS therapies is expected to guide the company effectively through these critical stages.
Danforth Health has also been engaged to establish robust operational capabilities that align with Protagenic's strategic objectives. This collaboration aims to develop institutional-grade processes and governance structures to prepare the company for future growth without incurring the overhead typically associated with larger organizations. Danforth has a history of servicing over 1,800 life science companies, providing cross-functional support essential for streamlining operations.
These engagements come on the heels of recent milestones achieved by Protagenic, including a successful separation from Phytanix, which enhanced its balance sheet by reducing liabilities and costs. Having completed a Phase 1 study demonstrating the safety and tolerability of PT00114, the company is positioned to enter Phase 2 clinical trials in 2026.
Protagenic Therapeutics has engaged Floyd Regulatory Strategic Consulting, led by Dr. Eric Floyd, Ph.D., MBA, as its Regulatory Affairs Advisor. Dr. Floyd has extensive experience in regulatory affairs, particularly in central nervous system (CNS) therapeutics.
Protagenic has engaged Danforth Health to establish operational processes and infrastructure suitable for its current stage of development. Danforth Health is noted for its capability in serving life science companies and aims to help Protagenic build investor-ready financial processes and governance.
PT00114 is Protagenic's lead clinical asset, which is an investigational neuropeptide targeting the TCAP pathway for the treatment of stress-related neuropsychiatric disorders, including anxiety, PTSD, and treatment-resistant depression.
Recent milestones for Protagenic include the completion of the Phytanix separation, which improved the company's balance sheet by reducing liabilities and annual costs, along with the completion of PT00114's Phase 1 multiple-dose safety study.
Protagenic Therapeutics plans to advance PT00114 into Phase 2 clinical studies in 2026, following the positive outcomes of the Phase 1 safety and tolerability data.
The source acknowledges that there are known and unknown risks and uncertainties related to pharmaceutical development that could lead to actual results differing from the company's expectations, particularly regarding the timing of clinical studies and therapeutic potential.
Dr. Eric Floyd has over 25 years of experience in regulatory leadership, having previously led strategic regulatory activities for CNS products at Lundbeck, among other notable pharmaceutical companies.
Protagenic Therapeutics, Inc. is listed on the OTCQB under the ticker symbol PTIX.