Enrollment is planned to begin during the first quarter of 2020.
T3D-959 is an investigative oral therapy that activates two proteins — called PPAR delta and PPAR gamma — involved in regulating blood sugar and triglyceride (fat) levels. PPAR activation regulates these metabolic parameters by boosting insulin sensitivity, an approach used to overcome insulin resistance in diabetes therapy.
Researchers think that T3D-959 may improve the glucose and lipid metabolism dysfunctions seen in Alzheimer’s disease.
“We believe T3D-959 has the potential to be Alzheimer’s disease remedial, to either slow, stop, or even reverse the course of disease as a single drug therapy,” John Didsbury, PhD, CEO of T3D Therapeutics, said in a press release.
“Our drug works to overcome aberrant glucose (sugar) and lipid (fat) metabolism in the brain that is inherent in AD. This dysfunctional metabolism causes protein mis-folding which in turn leads to plaques, tangles and inflammation,” he added.
Preclinical studies have shown that treatment with T3D-959 leads to improvements in motor function, preserved brain tissue, improved cognitive function, and reduced inflammation in a rodent model of Alzheimer’s disease.
An earlier open-label Phase 1/2 clinical study (NCT02560753) assessed the safety and efficacy of T3D-959 in 36 patients with mild-to-moderate Alzheimer’s disease. Participants received various doses of T3D-959 daily for two weeks.
Preliminary results showed that T3D-959 led to rapid improvement in cognitive tests in 53% of all participants. Final results found that the therapy was safe and well-tolerated at the different dosages. Further, T3D-959 showed potential efficacy for cognitive improvements and changes in brain glucose metabolism.
The safety and efficacy of T3D-959 will now be assessed in PIONEER — Prospective therapy to Inhibit and Overcome Alzheimer’s Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration — a double-blind, placebo-controlled, Phase 2 trial.
The study aims to enroll 256 patients with mild-to-moderate Alzheimer’s disease. The participants will receive one of three different doses of T3D-959 or a placebo for 24 weeks. Patients will be enrolled during the first quarter of 2020, with dosing also beginning in early 2020.
“We are eager to expand our testing of T3D-959 in Alzheimer’s patients in this new Phase 2 study since it uniquely targets mechanisms which we believe underlie the development of the memory deficits in this disorder,” said Warren Strittmatter, MD, chief medical officer of T3D Therapeutics and emeritus professor of neurology at Duke University Medical Center.
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