Clinical-trial results ‘disappointing’ for Accera’s Alzheimer’s treatment

BOULDER — Biopharma Accera Inc. in Boulder on Tuesday reported “disappointing” results of a clinical trial for a drug designed to treat mild-to-moderate Alzheimer’s disease.

Patients treated with the drug — AC-1204 — in the phase 3 trial didn’t demonstrate a significant difference at 26 weeks compared with patients treated with a placebo, the company said in a prepared statement.

AC-1204 proved to be safe and demonstrated high levels of tolerability with the most-prevalent adverse effect being mild “gastrointestinal disturbances,” which can include stomach pain, heartburn, diarrhea, constipation, nausea or vomiting.

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“The trial result is disappointing for us and the millions of patients, caregivers and physicians who urgently need new treatment options for this devastating disease,” said Dr. Charles Stacey, Accera’s president and chief executive. He said the outcome was unexpected, considering the results of a phase 2 study in which patients exhibited a statistically significant improvement.

“The formulation of the drug was changed between the phase 2 and phase 3 studies,” Stacey said.

Samuel Henderson, Accera’s vice president of research and development, said the change in formulation had the unintended consequence of lowering drug levels in patients.

“We are confident that our newly developed formulation will provide increased exposure and allow a more conclusive test of drug efficacy,” he said.