Drug startup ready for human testing phase
Tetra Discovery Partners prepares drug to help those with Alzheimer’s.
Grand Rapids is the kind of city where a drug development startup can be formed and have a drug ready for human testing in less than four years.
That’s exactly what Grand Rapids-based Tetra Discovery Partners has done.
Tetra recently announced it has taken the first step of a three-phase initiative to deliver to market a drug that could help those suffering from Alzheimer’s disease.
The new compound, called BPN14770, was designed to both improve memory and keep the brain-decaying disease at bay. The drug was created and developed as a joint effort through Tetra’s cooperative research agreement with the National Institutes of Health Blueprint Neurotherapeutics Network.
“There is a rapidly rising need for improved therapies for Alzheimer’s disease. BPN14770 offers a novel approach that intervenes in important neural pathways related to learning and memory storage that underlie daily cognitive function in patients with Alzheimer’s disease,” said Mark Gurney, chairman and CEO of Tetra.
“Tetra Discovery has begun an initial human safety study with the compound in healthy volunteers, and expects to expand this to initial explorations of the compound benefit for cognition during 2016.”
Alzheimer’s is a devastating disease that can ruin its victims and their loved ones both physically and financially, Gurney said. In 2015, the cost of health care for Alzheimer’s patients in the United States was about $226 billion, he said, adding that the last five years of care in an Alzheimer’s patient’s life generally costs about $300,000.
In the last four years, Gurney has raised about $18 million for the company, nearly $16 million of which was from outside grants and $2 million from local investors. A little less than $13 million went into the creation of BPN14770, he said.
“There is a great need for additional new drug targets and treatment approaches for Alzheimer’s disease that effectively reduce symptoms and potentially also slow disease progression,” said Scott Reines, chief medical officer of Tetra.
“Most current Alzheimer’s disease drug development is focused on amyloid-targeted approaches, which even if successful are likely to be more effective when used in combination with drugs addressing other mechanisms of the disease. The PDE4 biochemical pathway of memory and nerve synapse formation targeted by BPN14770 is well documented.”
There are three stages to clinical testing for BPN14770, Gurney said. In Phase I, Tetra is enrolling both young and old healthy subjects to see how their bodies accept the drug and to see if the drug will enhance the memory of the older subjects, so their memory skills match that of the younger subjects. If that happens, that “in and of itself would be useful,” he said.
“Tetra benefited greatly from the deep industry experience and commitment of NIH Blueprint consultants, CROs and staff, the National Institute of Neurological Disorders & Stroke and the National Institute of Aging,” he said.
“The cooperative research program was milestone driven with a rigorous focus on meeting pharmaceutical industry metrics for CNS drug quality and safety. BPN14770 has shown efficacy in multiple animal models of learning and memory with an excellent safety margin for human clinical trials.”
If the first phase is successful, Phase II would begin in 2017. During the second phase, Tetra would begin trials of the drug on Alzheimer’s patients, studying its enduring protective effect on cognitive function.
Phase III, if the first two phases are successful, would be a larger trial that would try to confirm Phase II and test the drug on thousands of patients. The drug would not be available to the market until at least 2022, Gurney said.
“Researchers have shown great interest in exploring how boosting synapse formation can potentially benefit not only (sufferers of) Alzheimer’s disease but also other cognitive disorders such as schizophrenia and learning/developmental disabilities, such as ‘Fragile X’ syndrome,” Reines said.
“We greatly look forward to advancing our clinical studies of BPN14770 to understand its potential in treating these serious neurological conditions, which represent enormous unmet medical needs.”
Although it might take a while to get the drug to the market — if it’s successful — Gurney is happy about the fact they’ve gotten this far this fast. Generally, it would take a larger company about five to seven years to make it to the human tests.
Being in Grand Rapids and being a smaller business allowed them to work with ease, he said.
“Because we’re a smaller business, we can make decisions rapidly. We could make a network of partners. We weren’t limited with resources,” he said.
“And the environment in Grand Rapids also helped the success of a company like Tetra. We’ve seen tremendous growth in the life science factor in the last 15 years. There’s been tremendous growth in our health care delivery and basic science …
“It is possible to create a life science (business) from scratch, create a drug and take it to human trials. And it’s the culture here that made it possible.”
Although it’s ready to grow, the problem Tetra now faces is “there’s nowhere to graduate to.” Grand Rapids needs to expand its SmartZone and have new construction of buildings for life sciences companies, he said.
“There’s a real need to expand the SmartZone and create a high-tech corridor adjacent to Spectrum and MSU, so life science companies can relocate where there’s other similar groups,” he said.
“It would need to be new construction because you would need a Class A building made from concrete and steel, and many of the old manufacturing buildings that are being repurposed have wooden floors, and they don’t meet the safety requirements for life science building.”
Even though the new drug could help curb Alzheimer’s disease, Gurney said he doesn’t expect to find a cure anytime soon.
“It’s difficult to contemplate a cure because the disease kills brain cells. And once they’re gone, it’s hard to replace them.”
“Ours is designed to improve memory by helping the brain improve connections. This drug is designed to facilitate forming memories and, by doing so, improve the resilience of (neural pathways affected by) the damage caused by the disease.”