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 https://clinicaltrials.gov/ct2/show/NCT03817684.