— Single Ascending Dose Portion of Phase 1 Trial Complete; Multiple Ascending Dose Study to Begin in June, Including First Look at Effects on Cognition —
GRAND RAPIDS, MI, USA I April 1, 2016 I Tetra Discovery Partners (“Tetra”) today announced that the company has successfully completed its initial Phase 1 single ascending dose (SAD) study of BPN14770 safety in 32 healthy volunteers. BPN14770 is the company’s experimental treatment aimed at improving memory and slowing the progression of Alzheimer’s disease. Tetra plans to begin its second Phase 1 trial of BPN14770 in June, which will study multiple ascending doses (MAD).
“We are very pleased with the excellent safety and pharmacology results seen in our initial SAD Phase 1 study of BPN14770 in healthy volunteers. BPN14770 showed linear dose proportionality, high estimated bioavailability, half-life adequate for once daily dosing, and relatively low variability between subjects,” said Mark Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra. “We believe this compound has the potential to benefit the lives of patients with Alzheimer’s disease as well as those with milder cognitive disorders, or with cognitive disorders that are part of other medical illnesses.
“The next study, to be conducted in approximately 80 healthy young and elderly volunteers, will examine both the safety and pharmacokinetics of multiple ascending doses of BPN14770 and seek an initial read out of its effects on cognition,” he added.
BPN14770 is a novel therapeutic agent that works through the PKA-CREB pathway to enhance synaptic action of the brain neurons involved in memory and cognition. This unique mechanism of action has the potential to improve cognitive and memory function in devastating disorders including Alzheimer’s disease, schizophrenia, and learning/developmental disabilities such as Fragile X syndrome. Tetra plans to evaluate the therapeutic potential of BPN14770 in reversing memory dysfunction as well as its ability to slow the progression of Alzheimer’s disease.
In the Multiple Ascending Dose trial (MAD), Tetra will study both young and elderly healthy volunteers who will receive daily doses of BPN14770. The subjects will be housed in a clinic setting and carefully monitored to detect any potential effects of the drug. In addition, elderly subjects will receive tests of their memory and cognitive ability throughout the dosing period. Particular attention will be paid to improvements in long-term memory, the key potential benefit of BPN14770. This study will pave the way for Phase 2 studies in patients with cognitive disorders including Alzheimer’s disease.
“We are hopeful that treatment with BPN14770 will lead to improved memory and cognition in individuals with non-amyloid or amyloid-related forms of dementia,” said Scott Reines, M.D., Ph.D., chief medical officer of Tetra.
Tetra thanks the National Institutes of Health and its innovative Blueprint Neurotherapeutics Program for their support and the active participation of the translational research experts that were involved in the BPN14770 project team, as well as the contracted drug discovery and development CROs who participated in this program.
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 Alzheimer’s disease and other brain disorders. Tetra uses structure-guided drug design to discover mechanistically novel, allosteric inhibitors of phosphodiesterase 4 (PDE4), which plays a key role in memory formation and learning. Tetra is both a recipient of a NIH Blueprint Neurotherapeutics Network cooperative research agreement, and also receives major funding through the National Institute of Aging, and the National Institute of Mental Health Small Business Innovation Research (SBIR) program. Tetra Discovery Partners is headquartered in Grand Rapids, Michigan and maintains a business office in Cambridge, Massachusetts. For more information, please visit the company’s website at http://www.tetradiscovery.com.
SOURCE: Tetra Discovery
Post Views: 34
— Single Ascending Dose Portion of Phase 1 Trial Complete; Multiple Ascending Dose Study to Begin in June, Including First Look at Effects on Cognition —
GRAND RAPIDS, MI, USA I April 1, 2016 I Tetra Discovery Partners (“Tetra”) today announced that the company has successfully completed its initial Phase 1 single ascending dose (SAD) study of BPN14770 safety in 32 healthy volunteers. BPN14770 is the company’s experimental treatment aimed at improving memory and slowing the progression of Alzheimer’s disease. Tetra plans to begin its second Phase 1 trial of BPN14770 in June, which will study multiple ascending doses (MAD).
“We are very pleased with the excellent safety and pharmacology results seen in our initial SAD Phase 1 study of BPN14770 in healthy volunteers. BPN14770 showed linear dose proportionality, high estimated bioavailability, half-life adequate for once daily dosing, and relatively low variability between subjects,” said Mark Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra. “We believe this compound has the potential to benefit the lives of patients with Alzheimer’s disease as well as those with milder cognitive disorders, or with cognitive disorders that are part of other medical illnesses.
“The next study, to be conducted in approximately 80 healthy young and elderly volunteers, will examine both the safety and pharmacokinetics of multiple ascending doses of BPN14770 and seek an initial read out of its effects on cognition,” he added.
BPN14770 is a novel therapeutic agent that works through the PKA-CREB pathway to enhance synaptic action of the brain neurons involved in memory and cognition. This unique mechanism of action has the potential to improve cognitive and memory function in devastating disorders including Alzheimer’s disease, schizophrenia, and learning/developmental disabilities such as Fragile X syndrome. Tetra plans to evaluate the therapeutic potential of BPN14770 in reversing memory dysfunction as well as its ability to slow the progression of Alzheimer’s disease.
In the Multiple Ascending Dose trial (MAD), Tetra will study both young and elderly healthy volunteers who will receive daily doses of BPN14770. The subjects will be housed in a clinic setting and carefully monitored to detect any potential effects of the drug. In addition, elderly subjects will receive tests of their memory and cognitive ability throughout the dosing period. Particular attention will be paid to improvements in long-term memory, the key potential benefit of BPN14770. This study will pave the way for Phase 2 studies in patients with cognitive disorders including Alzheimer’s disease.
“We are hopeful that treatment with BPN14770 will lead to improved memory and cognition in individuals with non-amyloid or amyloid-related forms of dementia,” said Scott Reines, M.D., Ph.D., chief medical officer of Tetra.
Tetra thanks the National Institutes of Health and its innovative Blueprint Neurotherapeutics Program for their support and the active participation of the translational research experts that were involved in the BPN14770 project team, as well as the contracted drug discovery and development CROs who participated in this program.
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 Alzheimer’s disease and other brain disorders. Tetra uses structure-guided drug design to discover mechanistically novel, allosteric inhibitors of phosphodiesterase 4 (PDE4), which plays a key role in memory formation and learning. Tetra is both a recipient of a NIH Blueprint Neurotherapeutics Network cooperative research agreement, and also receives major funding through the National Institute of Aging, and the National Institute of Mental Health Small Business Innovation Research (SBIR) program. Tetra Discovery Partners is headquartered in Grand Rapids, Michigan and maintains a business office in Cambridge, Massachusetts. For more information, please visit the company’s website at http://www.tetradiscovery.com.
SOURCE: Tetra Discovery
Post Views: 34
