Complete trial enrollment anticipated in early 2020 with topline results projected Q2 2020
Hispanics represent nearly 65% of early patient enrollment
Novel PDE4D Mechanism of Action is designed to improve cognition and memory
GRAND RAPIDS, Mich.–(BUSINESS WIRE)–#Alzheimers–Just ahead of World Alzheimer’s Day on September 21st, Tetra Therapeutics, a clinical-stage biotechnology company, today announced it has surpassed 50% enrollment – 65% of which are Hispanic patients– in its Phase 2 clinical trial (PICASSO AD) of BPN14770 in patients diagnosed with early Alzheimer’s disease (AD), since the trial’s initiation in May.
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 patients with AD.
“We are excited to see the enrollment of this trial progress at an unexpectedly rapid rate,” said Mark Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra Therapeutics. “It is promising to see our trial design and novel approach to potentially restoring or improving memory function attract a diverse patient population. The faster enrollment and early results from this Phase 2 trial may allow Tetra to accelerate the commercialization timeline for BPN14770 by a quarter or more which is significant to the business, our investors, and the patients who may benefit from this drug.”
“Alzheimer’s disease has an overwhelming impact on patients, their families, caregivers, and the health care system. Unfortunately, the recent news for drugs in large, late-stage clinical trials in Alzheimer’s disease has been terribly disappointing,” said Frank Longo, M.D., Ph.D., Professor and Chair of the Department of Neurology and Neurological Sciences at Stanford University who is also involved in the development of Alzheimer’s therapies. “There is a tremendous need for drugs with novel mechanisms of action while at the same time recruiting patients from underserved patient populations is imperative to better understand this devastating disease.”
According to the Centers for Disease Control and Prevention, among people ages 65 and older, Hispanics have the second highest prevalence of Alzheimer’s disease and related dementias (12.2%) behind African Americans (13.8%) and ahead of non-Hispanic whites (10.3%). By 2060, researchers estimate there will be 3.2 million Hispanics with Alzheimer’s disease and related dementias.
“Data suggest that the Hispanic population may be at greater risk to develop Alzheimer’s disease and dementia than other ethnic groups, and nearly 70 percent of Miami’s population is Hispanic,” commented Ernesto Diaz M.D., Principal Investigator at Linfritz Research Center, Miami, Florida. “Our clinic is pleased to participate in this clinical trial of a novel treatment being evaluated to potentially restore or improve cognition and memory in patients with an early diagnosis of Alzheimer’s disease.”
“By 2030, nearly 40 percent of Americans living with Alzheimer’s will be Latino or African American and our healthcare system is woefully unprepared for this shift,” said Jason Resendez, executive director of LatinosAgainstAlzheimer’s, a coalition convened by UsAgainstAlzheimer’s. “Given the increased risk of Alzheimer’s among Latinos, it is absolutely critical that we promote diversity and inclusion in Alzheimer’s research, care, and treatment.”
Initiated on May 10th, the PICASSO AD trial is a three-month, randomized, double-blind, placebo-controlled Phase 2 study being conducted at up to 60 sites across the United States. The trial is enrolling approximately 255 patients, ages 55-85, and to date has enrolled 142 patients. Enrollment is approximately three and a half months ahead of schedule, expected to be complete by early 2020 with topline results expected mid-2020.
BPN14770 is a selective inhibitor of phosphodiesterase‐4D (PDE4D) 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. Preclinical research has shown BPN14770 to trigger multiple compensatory mechanisms in the brain that in a humanized mouse model of amyloid beta1-42 neurotoxicity reduced memory impairment, damage to neuronal morphology, deficits in synaptic proteins and impaired neurological signaling. Tetra currently is conducting an investigational Phase 2 study of BPN14770 in adults with early Alzheimer’s disease and a second investigational Phase 2 study 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 Therapeutics
Tetra Discovery Partners is a clinical stage biotechnology company developing innovative products that address unmet medical needs such as in Fragile X Syndrome and Alzheimer’s disease. Tetra’s mission is to restore clarity of thought in people affected by Fragile X Syndrome, Alzheimer’s disease, or other conditions that impair human brain function. For more information, please visit the company’s website at http://www.tetratherapeutics.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.
Mark Gurney, Ph.D., Chief Executive Officer
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