TB006 / TrueBinding - LARVOL DELTA

New Investigational Drug TB006 FDA - Approved For Compassionate Use (openPR) - "TB006, a new investigational drug, has been approved by the US Food and Drug Administration (FDA) for compassionate use and is currently being evaluated in a clinical trial for Alzheimer's disease. The FDA's compassionate use designation allows patients with serious or life-threatening conditions to access investigational treatments when no satisfactory alternatives are available....Among the clinical sites authorized to provide TB006 under compassionate use is Brain Power Clinics, located in West Palm Beach, Florida."

FDA event • Alzheimer's Disease

A Phase 2a Multicenter Clinical Trial of TB006 in Participants with Parkinson's Disease (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: TrueBinding, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 2a Multicenter Clinical Trial of TB006 in Participants With Parkinson's Disease (clinicaltrials.gov) - P2 | N=62 | Not yet recruiting | Sponsor: TrueBinding, Inc.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=180 | Terminated | Sponsor: TrueBinding, Inc. | Active, not recruiting ➔ Terminated; Resource Constraints

Trial termination • Alzheimer's Disease • CNS Disorders

TB006SAD: Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: TrueBinding, Inc. | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

TrueBinding Receives FDA IND Go Ahead for Parkinson’s Phase 2A Clinical Trial (GlobeNewswire) - "TrueBinding...has cleared an FDA Investigational New Drug (IND) application for the Biologic IgG4 antibody neutralizing Galectin-3, TB006, for potential disease modification of Parkinson’s Disease....A multi-center, placebo-controlled, Phase 2A trial (NCT) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease. The trial will enroll adults aged 50 to 80 years of age who have confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, less than five (5) years since diagnosis, and currently on no other Parkinson’s Disease medications or only immediate-release Levodopa-containing therapy. The estimated enrollment for the trial is 62 patients, and the estimated primary completion date is Q1 2026."

IND • New P2a trial • Parkinson's Disease

TB006 for Autism Spectrum Disorder (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Rossignol Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Autism Spectrum Disorder • Genetic Disorders • LGALS3

TB006 for Autism Spectrum Disorder (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Rossignol Medical Center

New P2 trial • Autism Spectrum Disorder • Genetic Disorders • LGALS3

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: TrueBinding, Inc. | N=120 ➔ 0 | Trial completion date: Apr 2024 ➔ Dec 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Apr 2024 ➔ Dec 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Cardiovascular • Ischemic stroke

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=154 | Completed | Sponsor: TrueBinding, Inc. | Phase classification: P1b/2a ➔ P1/2

Phase classification • Alzheimer's Disease • CNS Disorders

TB006 Expanded Access (EA) Compassionate Use (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: TrueBinding, Inc.

New trial • Alzheimer's Disease • CNS Disorders • Dementia

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease (clinicaltrials.gov) - P1b/2a | N=140 | Completed | Sponsor: TrueBinding, Inc. | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: TrueBinding, Inc. | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

RESULTS FROM A PHASE 1B/2A STUDY OF AN ANTI-GALECTIN-3 MONOCLONAL ANTIBODY IN PATIENTS WITH MODERATE TO SEVERE ALZHEIMER'S DISEASE (ADPD 2023) - P2 | "Conclusions TB006 demonstrated evidence of AD reversal in this short-term treatment study. TB006 was safe and well tolerated."

Clinical • P1/2 data • Alzheimer's Disease • CNS Disorders • Dementia • Mental Retardation • Psychiatry • Aβ42

Results from a clinical Study of an Anti-Galectin-3 Monoclonal antibody in Patients with Moderate to Severe Alzheimer’s Disease (CTAD 2022) - "TB006 demonstrated evidence of AD reversal in this short-term treatment study. TB006 was safe and well tolerated."

Clinical • Late-breaking abstract • Alzheimer's Disease • CNS Disorders • Dementia • Immunology • Mental Retardation • Psychiatry • LGALS3

POTENTIAL REVERSAL OF ALZHEIMER’S DISEASE. (CTAD 2022) - "Pre-clinical studies show that TB006 is an efficacious therapeutic entity through preventing formation of toxic oligomers and blocking or even reversing AD progression. Clinically, TB006 has shown a superior safety profile without any drug-related adverse events in a nearly finished healthy volunteer trial. Promising efficacy data are expected in Q2/2022 from the ongoing phase I/II AD trial."

Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Cognitive Disorders • Hematological Disorders • Immunology • Inflammation • Movement Disorders • Parkinson's Disease • LGALS3

TrueBinding Highlights the Potential of TB006’s Unique Mechanism of Action as a Novel Approach for the Treatment of Alzheimer’s Disease at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) Conference (GlobeNewswire) - “TrueBinding Inc…highlighted the unique method of action (MOA) of TB006, an investigational monoclonal antibody against Galectin-3 (Gal-3) for the treatment of mild to severe AD, at the recent 15th Clinical Trials on Alzheimer’s Disease (CTAD) Conference….In preclinical studies TB006...was shown to block Gal-3 and dissolve the toxic aggregates, which reversed disease progress in animal models of AD. ‘Our monoclonal antibody, TB006, targets Gal-3, which acts as a glue and has a role in the formation of toxic protein oligomers that compromise normal neuronal function in the brain and leads to disease progression’…An ongoing open-label extension study assessing monthly injections of TB006 at 4,000 mg in over 100 participants is generating long-term safety and efficacy data, with initial, interim data expected in the first quarter of 2023. A longer-term, 12-month, randomized, placebo-controlled Phase 2b trial is planned.”

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

TrueBinding Announces Results of TB006 Phase 1b/2 Placebo Controlled Proof-of-Concept Trial Showing Improvement on the Primary Cognition and Function Endpoint in Patients with Mild to Severe Alzheimer’s Disease (GlobeNewswire) - P1b/2 | N=140 | NCT05074498 | Sponsor: TrueBinding, Inc. | "TrueBinding Inc...announced top line results from its Phase 1b/2 proof-of-concept trial of TB006...for the treatment of mild to severe Alzheimer's disease (AD) with baseline Mini Mental State Examination (MMSE) scores of 2-24). The primary endpoint (CDR-SB*, a patient and caregiver combined assessment) showed improvement that trended toward significance (p=0.08), a startling finding given the one-month treatment duration. Key secondary endpoints also showed improvements that reached or trended toward statistically significant results...TB006 treatment demonstrated improvement on the secondary endpoint, the MMSE** with statistical significance (p=0.02) at Day 36. TB006 also significantly reduced Aβ 42 plasma levels, further evidence of an impact on the underlying disease....TrueBinding will present the TB006 study results on December 2, 2022, at the Clinical Trials on Alzheimer’s Congress (CTAD)."

P1/2 data • Alzheimer's Disease • CNS Disorders

A Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease. (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: TrueBinding, Inc. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

An Open-label Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease. (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: TrueBinding, Inc. | N=120 ➔ 180

Enrollment change • Alzheimer's Disease • CNS Disorders

An Open-label Long Term Extension Study to Assess the Safety of TB006 in Participants With Alzheimer's Disease. (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: TrueBinding, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders

Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease (clinicaltrials.gov) - P1b/2a | N=140 | Active, not recruiting | Sponsor: TrueBinding, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke (clinicaltrials.gov) - P2; N=112; Not yet recruiting; Sponsor: TrueBinding, Inc.

Clinical • New P2 trial • Cardiovascular • Ischemic stroke • MRI

Novel therapeutic efficacy of Galectin-3 antibody for treating Alzheimer’s disease (CTAD 2021) - "Taken together, our pre-clinical studies show that, attenuating Gal-3 is an immensely efficacious therapeutic entity by degrading toxic Aβ42 oligomers and blocking AD progression, which in turn reverses cognitive deficits that already occur. After extensive scrutiny by the FDA, our clinical candidate TB006 is under phase I/II trial and will possibly help AD patients to have a better quality of life. Conflict of Interest: All authors are paid employees of Truebinding Inc"

Clinical • Late-breaking abstract • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders • Immunology • Inflammation • LGALS3 • TNFA

TB006SAD: Sequential Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of TB006 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: TrueBinding, Inc.

Clinical • New P1 trial • Alzheimer's Disease • CNS Disorders