Tetra Discovery Partners Initiates Phase 2 Clinical Trial of BPN14770 in Patients with Early Alzheimer’s Disease
Trial to evaluate effects of selective inhibitor of phosphodiesterase-4D on memory and cognitive measures
Grand Rapids, MI — Tetra Discovery Partners, a clinical-stage biotechnology company, today announced the initiation of a Phase 2 clinical trial (PICASSO AD) of BPN14770 in patients diagnosed with early Alzheimer’s disease (AD). BPN14770, a novel agent that selectively inhibits phosphodiesterase-4D (PDE4D), is designed to enhance early and late stages of memory formation and to potentially improve cognition and memory in central nervous system (CNS) disorders including AD.
“Recent estimates cite AD as the 6th leading cause of death in the United States, and the only one with no effective means to prevent, cure, or slow its progression. This disease has an overwhelming impact not only on those diagnosed with the condition, but on families, caregivers, and the health care system,” said Paul Stephen Aisen, M.D., Professor of Neurology; Director, Alzheimer's Therapeutic Research Institute, Keck School of Medicine of the University of Southern California (USC). “We are excited to see agents with novel mechanisms of action expand into a patient population in need of new treatments aimed at improving the devastating symptoms of the disease.”
The PICASSO AD trial is a three-month randomized, double-blind, placebo-controlled Phase 2 study that will be conducted at up to 60 sites across the United States. The trial will enroll approximately 255 patients, ages 55-85, with a clinical diagnosis of early Alzheimer’s disease, and will consist of three parallel study arms to evaluate two twice-daily doses of BPN14770 versus placebo. The primary endpoint for the trial will be the change from baseline scores in a standardized clinical assessment of memory (Repeatable Battery for Assessment of Neurological Status - Delayed Memory Index; RBANS-DMI). Secondary endpoints will include changes from baseline in a variety of other standardized tests and clinical assessments of memory, cognition, and daily function, as well as pharmacokinetic measurements. Tetra is conducting the trial with the assistance of the clinical research organization, Syneos Health.
“Results of previous Phase 1 studies with BPN14770 in healthy elderly volunteers suggested cognitive benefit, as observed in two different tests of working (immediate) memory,” Mark Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra Discovery Partners. “We are eager to expand our studies of BPN14770 to the growing population of patients diagnosed with early Alzheimer’s disease, where a drug that is successful in restoring or improving memory function could offer enormous benefit.” Working memory is a system for temporarily storing and managing the information required to carry out complex cognitive tasks such as learning, reasoning, and comprehension. The part of the brain responsible for working memory is also responsible for focus and concentration. Working memory is a domain of cognition that is impacted by Alzheimer’s disease.
For further information about the trial and patient enrollment criteria please visit clinicaltrials.gov/ct2/show/NCT03817684.
BPN14770 is a novel therapeutic agent that selectively inhibits phosphodiesterase-4D (PDE4D) to enhance early and late stages of memory formation. This unique mechanism of action has the potential to improve cognitive and memory function in devastating CNS disorders including Fragile X Syndrome, Alzheimer’s disease and other dementias, learning/developmental disabilities and schizophrenia. Preclinical animal models show that BPN14770 has the potential to promote the maturation of connections between neurons, which is impaired in patients with Fragile X Syndrome, and to protect connections between neurons which otherwise are lost in patients with Alzheimer’s disease. Tetra currently is conducting an investigational Phase 2 study of BPN14770 in adults with Fragile X Syndrome, an indication for which BPN14770 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). BPN14770 currently is approved for investigational use only by the U.S. Food and Drug Administration and is not currently approved for marketing in any territory.
About Tetra Discovery Partners
Tetra Discovery Partners is a clinical stage biotechnology company developing a portfolio of therapeutic products that will bring clarity of thought to people suffering from Fragile X Syndrome, Alzheimer's disease, traumatic brain injury, and other brain disorders. Tetra uses structure-guided drug design to discover mechanistically novel, allosteric inhibitors of phosphodiesterase 4 (PDE4), an enzyme family that plays key roles in memory formation, learning, neuroinflammation, and traumatic brain injury. BPN14770 was developed through a cooperative research agreement with the Blueprint Neurotherapeutics Program of the National Institutes of Health with funding from the National Institute on Aging, National Institute on Neurological Disorders and Stroke, the National Institute of Mental Health, and the Alzheimer’s Drug Discovery Foundation. Tetra Discovery Partners is headquartered in Grand Rapids, Michigan. For more information, please visit the company's website at tetradiscovery.com.
Forward looking Statements
Certain other statements made throughout this press release that are not historical facts contain forward-looking statements regarding the company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
Tetra Discovery Partners Contacts:
Mark Gurney, Ph.D., Chief Executive Officer Tetra Discovery Partners, Inc.
Joan Kureczka Bioscribe, Inc.