T3D-959 / T3D Therap, Bayer - LARVOL DELTA

Developing Topics. (PubMed, Alzheimers Dement) - "Co-primary endpoints ADAS-Cog11 and ADCS-CGIC were met per protocol, approaching statistical significance at week 24. T3D-959 demonstrated significant improvement over placebo in plasma Aβ42/40 ratio and in plasma neurogranin. Biomarkers of all three AD diagnostic criteria, Amyloid/Tau/Neurodegeneration, were improved, as well as markers of inflammation, insulin resistance and dysfunctional lipid metabolism. Results demonstrate a strong safety profile and evidence of slowing of clinical and biological decline."

Biomarker • Clinical • Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • Aβ42

A Novel Way to Reduce Alzheimer’s Amyloid Plaque Burden, Phase 2 Clinical Trial Results of T3D-959 to be Presented by T3D Therapeutics at AAIC (PRNewswire) - "T3D Therapeutics, Inc...today announced that CEO, John Didsbury, will be presenting new Phase 2 results in a modified intent-to-treat population of mild to moderate Alzheimer's patients at AAIC. The poster presentation will take place on Sunday, July 28th in Philadelphia, PA."

P2 data • Alzheimer's Disease • CNS Disorders

Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed with Mild-to-Moderate Alzheimer’s Disease: New Results in a Modified Intent-to-Treat Population (AAIC 2024) - "Secondary endpoint plasma Aβ42/40 ratio was met, with significant improvement in the T3D-959 30mg and 45mg groups vs placebo (30mg: P =0.011; 45mg: P =0.033), with a similar magnitude of effect as lecanemab at 6-months. Co-primary endpoints ADAS-Cog11 and ADCS-CGIC were met per protocol, approaching statistical significance at week 24. T3D-959 demonstrated significant improvement over placebo in plasma Aβ42/40 ratio and in plasma neurogranin. Biomarkers of all three AD diagnostic criteria, Amyloid/Tau/Neurodegeneration, were improved, as well as markers of inflammation, insulin resistance and dysfunctional lipid metabolism."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • Aβ42

T3D-959 improves cognitive function in certain patients: Study (Alzheimer's News Today) - "'The exciting results of this study show potential to modify the course of Alzheimer's disease in a unique way,' said Michael Weiner, MD...a principal investigator at the Alzheimer's Disease Neuroimaging Initiative. 'I look forward to seeing these results confirmed and expanded in a larger and longer Phase 2b/3 clinical trial.'"

Media quote

T3D Therapeutics Announces Positive Top-Line Results from the Phase 2 PIONEER Trial of T3D-959 in Mild-To-Moderate Alzheimer’s Disease (BioSpace) - P2 | N=250 | PIONEER (NCT04251182) | Sponsor: T3D Therapeutics, Inc. | "T3D Therapeutics presented top-line results from its Phase 2 PIONEER study at the 16th international conference on Clinical Trials in Alzheimer's Disease (CTAD)....The ITT population (all randomized patients) had significant improvement with T3D-959 treatment vs. placebo: In a biomarker of amyloid plaque burden, plasma Ab42/40 ratio (PrecivityAD™), with 30mg of T3D-959 vs. placebo (p=0.021)....In a plasma biomarker of neurodegeneration, neurogranin (p=0.013). In multiple plasma metabolomic biomarkers of AD neurodegeneration, inflammation, insulin resistance, mitochondrial dysfunction and oxidative stress....55% of subjects had a pTau-217/Non-pTau-217 ratio ≥0.015 indicating they had AD pathology (high pTau-217 ratio group) and exhibited cognitive decline in the placebo group consistent with AD."

P2 data • Alzheimer's Disease • CNS Disorders

Topline Results From the Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed With Mild-toModerate Alzheimer's Disease (CTAD 2023) - P2 | "The secondary endpoint, plasma Ab42/40 ratio change, was met in the T3D-959 30-mg group (increasing at week 24) vs. placebo decreasing (0.0023 vs -0.0013; P=0.0206).This was a similar magnitude of effect on Ab42/40 as lecanemab at 6-months. A high plasma pTau-217 ratio likely defines an AD population responsive to T3D-959 therapy. ADASCog11 endpoint was met in the high pTau-217 T3D-959 30-mg group. Biomarkers of all three AD diagnostic criteria (Amyloid/ Tau/Neurodegeneration) were significantly, numerically, or trending improved, as well as markers of inflammation, insulin resistance and dysfunctional lipid metabolism."

Clinical • Late-breaking abstract • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • Metabolic Disorders • Aβ42

T3D Therapeutics Selected to Present Topline Results from the Phase 2 PIONEER Study of T3D-959 as Late Breaking News at the 16th Clinical Trials on Alzheimer’s Disease Conference (CTAD) (PRNewswire) - "T3D Therapeutics, Inc...announced today it has been selected to present, as late breaking news, topline results from its Phase 2 PIONEER clinical trial of T3D-959 in mild-to-moderate severity AD patients at the 16th international conference on Clinical Trials in Alzheimer's Disease (CTAD)....The opening day oral presentation by T3D will report longitudinal safety and efficacy data from the PIONEER study."

Late-breaking abstract • P2 data • Alzheimer's Disease • CNS Disorders

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2 | N=250 | Completed | Sponsor: T3D Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2 | N=256 | Active, not recruiting | Sponsor: T3D Therapeutics, Inc. | Trial completion date: May 2023 ➔ Feb 2023 | Trial primary completion date: Apr 2023 ➔ Jan 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

The PIONEER Study: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial of the Effects of T3D-959 on Safety, Cognition, Function and Plasma Biomarkers in Mild to Moderate Alzheimer’s Disease Subjects: Study Update. (AAIC 2022) - No abstract available

Biomarker • Clinical • P2 data • Alzheimer's Disease • CNS Disorders

HIGHLIGHTS OF THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2022 [Google translation] (PRNewswire) - “At AAIC 2022, T3D Therapeutics reported positive interim results from its Phase 2 trial of T3D-959, which seeks to overcome insulin resistance in the brain and restore brain metabolic health. These encouraging preliminary results are a positive sign, with final results expected in 2023.”

P2 data • Alzheimer's Disease • CNS Disorders

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2 | N=256 | Active, not recruiting | Sponsor: T3D Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

PIONEER, A PHASE 2 STUDY TO EVALUATE TREATMENT WITH T3D-959 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE: STUDY DESIGN AND UPDATE. (ADPD 2022) - P2 | "The PIONEER Study will determine the clinical efficacy and safety profile of T3D-959 in individuals with mild to moderate AD. PIONEER is supported by NIA/NIH, under award R01AG061122 and by the Alzheimer’s Association’s Part the Cloud Gates Partnership Grant Program."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Immunology • Inflammation • Metabolic Disorders • Solid Tumor

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2 | N=256 | Recruiting | Sponsor: T3D Therapeutics, Inc. | Trial completion date: Jul 2022 ➔ May 2023 | Trial primary completion date: Jul 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

PIONEER, a Phase 2 Study to Evaluate Treatment with T3D-959 in Patients with Mild to Moderate Alzheimer’s Disease: Study Design and Update (CTAD 2021) - P2, P2a | "The etiology of AD remains unknown. Significant research effort has focused on amyloid plaques and tau tangles as causation however no clinical trials of therapies directed at these pathologies have provided consistent clinically meaningful benefit to patients. Consequently, research focus has recently shifted towards inflammation as causation."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Immunology • Inflammation • Metabolic Disorders • Solid Tumor • FDG PET

T3D Therapeutics, Inc.: T3D Therapeutics Announces First Patient Dosed in its Phase 2 Study of T3D-959 for the Treatment of Mild to Moderate Alzheimer's Disease (BioSpace) - "T3D Therapeutics...announced today the initiation of dosing in a Phase 2 clinical study of neurometabolic regulator T3D-959 in patients with mild to moderate Alzheimer's disease, the PIONEER Study....The Phase 2 PIONEER trial has resumed after pausing and making study adaptations in response to the COVID-19 pandemic."

Trial status • Alzheimer's Disease • CNS Disorders

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2; N=256; Recruiting; Sponsor: T3D Therapeutics, Inc.; Suspended ➔ Recruiting

Clinical • Enrollment open • Alzheimer's Disease • CNS Disorders

[VIRTUAL] ALZHEIMER’S DISEASE CLINICAL TRIAL ADAPTATIONS TO COVID-19 (ADPD 2021) - "We present the PIONEER study – T3D959-202 as an example of implementing this new framework for remote adaptations to AD clinical trials... The hybrid remote/onsite research framework in the PIONEER study implements modifications that overcome obstacles to trial conduct presented by the COVID-19 pandemic. Application of this framework provide: (1) support alternatives to onsite visits; (2) facilitates technology use to allow for seamless adaptation to at-home visits; (3) maintains the integrity of study data; and (4) plans for modifications to statistical analysis due to new impediments to subject retention."

Clinical • Alzheimer's Disease • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2; N=256; Suspended; Sponsor: T3D Therapeutics, Inc.; Trial completion date: Jan 2022 ➔ Sep 2022; Initiation date: Jul 2020 ➔ Feb 2021; Trial primary completion date: Jan 2022 ➔ Sep 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

T3D Therapeutics Receives a Research Award from the Alzheimer's Association Part the Cloud-Gates Partnership Grant Program (PRNewswire) - "T3D Therapeutics...announced today that it has received a $740,000 grant from the Alzheimer's Association Part the Cloud-Gates Partnership Grant Program in support of clinical trial biomarker studies. These biomarker studies are an integral part of the upcoming Phase 2 clinical study of T3D-959, a novel, metabolic-focused AD drug treatment....The Phase 2 PIONEER study...is expected to initiate patient dosing in early 2021."

Financing • Grant • Trial status • Alzheimer's Disease • CNS Disorders

[VIRTUAL] The PIONEER Study: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial of the Effects of T3D-959 on Safety, Cognition, Function and Plasma Biomarkers in Mild to Moderate Alzheimers Disease Subjects: Rationale and Study Design (AAIC 2020) - P2a | "PIONEER is designed to evaluate the efficacy and safety of multiple dose strengths of T3D-959 in patients with mild to moderate severity AD."

Biomarker • Clinical • P2 data • Alzheimer's Disease • CNS Disorders • FDG PET • PPARG

[VIRTUAL] The PIONEER Study: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial of the Effects of T3D-959 on Safety, Cognition, Function and Plasma Biomarkers in Mild to Moderate Alzheimers Disease Subjects: Rationale and Study Design (AAIC 2020) - P2a | "PIONEER is designed to evaluate the efficacy and safety of multiple dose strengths of T3D-959 in patients with mild to moderate severity AD."

Biomarker • Clinical • P2 data • Alzheimer's Disease • CNS Disorders • FDG PET • PPARG

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2; N=256; Suspended; Sponsor: T3D Therapeutics, Inc.; Trial completion date: Aug 2021 ➔ Jan 2022; Initiation date: Feb 2020 ➔ Jul 2020; Recruiting ➔ Suspended; Trial primary completion date: Aug 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Trial suspension • Alzheimer's Disease • CNS Disorders

Alzheimer’s researchers link glucose metabolism to disease pathology, uncovering new drug targets (FierceBiotech) - "The NIA funded early studies of the drug T3D-959 from North Carolina-based T3D Therapeutics, which is targeting aberrant glucose and fat metabolism in the brain. Last November, T3D raised $15 million in a series B funding round to advance the drug into clinical trials."

Financing • CNS Disorders • Tauopathies And Synucleinopathies

Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects (clinicaltrials.gov) - P2; N=256; Recruiting; Sponsor: T3D Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open