BioPharma

Company starts Phase II study of Alzheimer’s drug – and it’s not going after amyloid beta

Tetra Discovery Partners announced the initiation of a Phase II study of BPN14770, which targets phosphodiesterase-4D, or PDE4D. The trial is expected to enroll about 255 patients at 60 sites in the US.

Dementia or brain damage and injury as a mental health and neurology medical symbol with a thinking human organ made of crumpled paper torn in pieces as a creative concept for alzheimer disease.

With several high-profile failures of Alzheimer’s disease drugs over the last several years – most recently Biogen and Eisai’s aducanumab – some firms have been looking for alternatives to the amyloid beta plaques that most of the field has focused on for decades.

One is Grand Rapids, Michigan-based Tetra Discovery Partners, which said Wednesday that it had started a Phase II trial of its drug, BPN14770, in patients with early Alzheimer’s. The drug inhibits phosphodiesterase-4D, also known as PDE4D, and is designed to enhance early and late stages of memory formation and potentially improve cognition and memory.

The trial, PICASSO AD, is a randomized, double-blind, placebo-controlled study designed to enroll about 255 patients aged 55-85 at up to 60 sites across the US. The three-month trial use change from baseline scores in standardized clinical assessment of memory as its primary endpoint. According to its page on ClinicalTrials.gov, PICASSO AD has not yet begun recruiting, and no active sites are listed, while June 2020 is the estimated study completion date.

The company has pointed to early Phase I data in elderly healthy volunteers indicating BPN14770 is able to improve cognition.

“Recent estimates cite AD as the sixth leading cause of death in the United States, and the only one with no effective means to prevent, cure or slow its progression,” University of Southern California professor of neurology Dr. Paul Stephen Aisen said in a statement on behalf of Tetra. “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.”

PDE4D has been the subject of other research in Alzheimer’s as well. A study led by researchers at the University of Genoa in Italy and published in April 2017 in the journal Nature Scientific Reports looked at another PDE4D inhibitor, GEBR-32a.

PDE4D is one of many targets in Alzheimer’s that researchers have turned to as the target most of the field had been focusing on – amyloid beta plaques – appears not to be as promising as once thought. The decision last month by Biogen and Eisai to halt their Phase III studies of aducanumab due to the likelihood of the program’s failure was especially devastating to the amyloid beta hypothesis given that the drug was so effective at reducing plaques, but still did not produce a clinical benefit. That has prompted researchers and investors to look at other potential targets, like the protein tau and also genetics.

Photo: wildpixel, Getty Images

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