Alzheimer’s Anti-Tau Drug Fails Phase III, Shows Benefit in Monotherapy

Abstract

TORONTO — A phase III trial of an anti-tau drug has posted negative topline results, conferring no cognitive or functional benefi ts when given in conjunction with standard-of-care Alzheimer’s disease medications. The drug, LTMX (TauRx), also did not slow the progression of brain atrophy on imaging in either of two doses tested, according to a company press release. Although the study didn’t meet its clinical endpoints in the overall cohort of 891 patients with mild to moderate disease, TauRx promoted it as “promising,” based on a subgroup analysis of the 15% of patients who took the drug as monotherapy. Among these patients, LMTX was associated with dose-dependent, statistically signifi cant improvements in the Alzheimer’s Disease Assessment Scale measures of cognition (ADAS-cog) and Alzheimer’s Disease Cooperative Study Activities of Daily Living inventory (ADCS-ADL). The drug was also associated with a slowing of brain ventricular expansion, compared with controls, suggesting that it could be preserving brain mass. Nevertheless, the trial must be read as another negative one, said David S. Knopman, MD, of the Mayo Clinic, Rochester, MN, who moderated a press briefing where the data were presented. “I think the secondary results are interesting, especially imaging fi ndings. But ... because this is a small subset of just 15%, it’s very diffi cult to interpret.”