Published in Health Care

Drug developer’s clinical trial enrollment going faster than expected

BY Friday, September 20, 2019 09:50am

GRAND RAPIDS — Tetra Therapeutics says it is enrolling patients faster than expected for a clinical trial on a potential new drug to treat Alzheimer’s disease.

The Grand Rapids-based Tetra Therapeutics, formerly known as Tetra Discovery Partners Inc., said it now has more than half of the patients needed for the Phase 2 clinical trial on a compound known as BPN14770.

Mark Gurney MiBiz file photo: Adam Bird

That enrollment progress could lead to quicker commercialization of the new drug, if clinical trials prove successful. The drug has shown promise during research and development to improve memory function in Alzheimer’s patients.

“We are excited to see the enrollment of this trial progress at an unexpectedly rapid rate,” Mark Gurney, chairman and CEO of Tetra Therapeutics, said in a statement. “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.”

Launched in May, the clinical trial seeks to enroll about 255 patients between 55 and 85 years old at 60 sites in the U.S. To date, Tetra Therapeutics has enrolled 142 patients, putting the clinical trial three and a half months ahead of schedule. The company expects to complete the trial by early 2020 and have results around midyear.

Nearly two-thirds of the patients enrolled in the clinical trial are Hispanic, a population that data suggest may have a higher risk of developing Alzheimer’s disease than other ethnic groups, said Dr. Ernesto Diaz, principal Investigator at Linfritz Research Center, Miami, Fla.

“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 that’s part of the advocacy group USAgainstAlzheimer’s based in Washington, D.C.

“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,” Resendez said in a statement issued this week by Tetra Therapeutics.

Tetra Therapeutics cites U.S. Centers for Disease Control and Prevention research that shows among people 65 and older, Hispanics have the second-highest prevalence of Alzheimer’s disease and related dementias, at 12.2 percent. That’s behind African Americans at 13.8 percent and ahead of non-Hispanic whites at 10.3 percent.

In late 2018, Tetra Therapeutics secured a $40 million investment by Japanese pharmaceutical company Shionogi & Co. Ltd. The investment gave the company a strategic partner and capital to test and commercialize the drug compound that could treat not just Alzheimer’s disease but Fragile X Syndrome, a form of autism.

Shionogi & Co.’s investment potentially could quadruple to $160 million through additional payments and future royalties if the Grand Rapids-based Tetra Discovery meets clinical, regulatory and commercialization milestones.

The initial $40 million strategic investment included an upfront $5 million payment for a licensing fee and a $35 million minority equity investment in Tetra Discovery. In exchange, Tetra Discovery granted Shionogi & Co. development rights to the drug compound in Japan, Korea and Taiwan.

Read 4614 times Last modified on Friday, 20 September 2019 11:40