T3D Therapeutics, Inc. (“T3D Therapeutics” or the “Company”), a biopharmaceutical company specializing in the development of ‘First-in-Class’ and ‘Best-in-Class’ disease-modifying, breakthrough medicine for the treatment of Alzheimer’s disease and other neurodegenerative diseases, announced it has engaged Clinilabs Drug Development Corporation (“Clinilabs”) as the contract research organization (“CRO”) for its upcoming phase 2 trial of T3D-959 named the PIONEER Study (Prospective therapy to Inhibit and Overcome Alzheimer’s Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration).
Clinilabs is a global, full-service CRO, the only one focused exclusively on central nervous system (CNS) drug development, an area of significant unmet need. Clinilabs specializes in mental health, neurological and substance abuse disorders, providing personalized service to customers of all sizes for projects of all scope across more than 40 countries.
“Designing the re-start of the PIONEER Study in adaptation to the current Covid-19 pandemic was a significant milestone for T3D Therapeutics and we are excited to see our hard work coming to fruition,” commented John Didsbury, Ph.D., President and CEO of T3D Therapeutics. “We believe that with Clinilabs’ exclusive focus on CNS drug development, we are optimally positioned for the successful execution of this trial.”
“The relationship between T3D Therapeutics and Clinilabs showcases a strong partnership between two organizations that are devoted to addressing an unmet need for patients with a compound that offers considerable hope to patients with mild to moderate Alzheimer’s disease,” commented Nancy Cameron, Vice President of Clinical Operations at Clinilabs. “Our team is committed to the success of this trial, to the Investigators participating nationwide, and to the patients and families who choose to enroll.”
After a temporary, pandemic-related pause, recruitment of new mild to moderate Alzheimer’s disease subjects into the PIONEER Study is expected to resume in early 2021 at up to 50 clinical sites nationwide and enrolling 256 patients. T3D is excited to be working with Clinilabs on the development of T3D-959, which has the potential to become a transformational drug therapy by targeting aberrant glucose and lipid metabolism leading to the neurodegeneration of Alzheimer’s disease.
About T3D Therapeutics, Inc.
T3D Therapeutics, Inc. is a privately-held, Research Triangle Park, NC-based company. The Company has an exclusive license to T3D-959, its lead product candidate, and a platform of structurally-related molecules. T3D Therapeutics’ mission is to develop and commercialize T3D-959 for the treatment of Alzheimer’s disease and Mild Cognitive Impairment. T3D-959 is a small molecule, orally-delivered, brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders. For more information visit http://www.t3dtherapeutics.com/.
About Clinilabs Drug Development Corporation
Clinilabs Drug Development Corporation is a global, full-service contract research organization (CRO), the only one focused exclusively on central nervous system (CNS) drug development, an area of significant unmet need. Clinilabs is dedicated to bringing new therapies to patients living with mental health, neurological and substance abuse disorders. Clinilabs partners with customers to deliver a full, first-in-human to Phase 3 spectrum of high quality, timely and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market.
Clinilabs has conducted more than 675 CNS clinical trials and played a pivotal role in the approval of 19 new therapies in 10 different indications to help transform the lives of patients. For more information, visit http://www.clinilabs.com/.
Clinilabs Drug Development Corporation
Jeanine M. Estrada