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, Mich.–(BUSINESS WIRE)–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.

About BPN14770

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 http://www.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.

Contacts

Mark Gurney, Ph.D., Chief Executive Officer
Tetra Discovery
Partners, Inc.
[email protected]

For Media:
Joan Kureczka
Bioscribe, Inc.
[email protected]