cysteamine-pantetheine disulfide (TTI-0102) / VA San Diego Healthcare System, Thiogenesis Therap - LARVOL DELTA

Thiogenesis Receives Confirmatory Guidance on IMPD for Pediatric MASH Phase 2a Clinical Trial in Europe and Core Patent Granted in EU (The Globe and Mail) - "Thiogenesis Therapeutics, Inc...announced that the Committee for Medicinal Products for Human Use ('CHMP') of the European Medicines Agency ('EMA') has provided scientific advice supporting the company's submission of an Investigational Medicinal Product Dossier ('IMPD') for a Phase 2a clinical trial in pediatric patients with metabolic dysfunction-associated steatohepatitis...In parallel with the clinical advancement of TTI-0102, Thiogenesis has recently been granted a European Union patent for its asymmetric disulfide prodrugs of cysteamine, titled 'Compositions for Controlled Release of Cysteamine and Systemic Treatment of Cysteamine Sensitive Disorders - PCT Pub No. WO2017161318.' This intellectual property establishes the company's competitive position in both mitochondrial and metabolic disease indications until 2038."

CHMP • New P2a trial • Patent • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS) (clinicaltrials.gov) - P2 | N=18 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc.

New P2 trial • Metabolic Disorders

A Study to Assess TTI-0102 vs Placebo in MELAS Patients (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Thiogenesis Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • CNS Disorders • Metabolic Disorders

A Study to Assess TTI-0102 Vs Placebo in MELAS Patients (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc. | Trial completion date: Oct 2025 ➔ Jun 2026 | Initiation date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2025 ➔ Apr 2026

Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • CNS Disorders • Metabolic Disorders

A Study to Assess TTI-0102 vs Placebo in MELAS Patients (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc.

New P2 trial • Cardiovascular • CNS Disorders • Metabolic Disorders

Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Thiogenesis Therapeutics, Inc. | N=60 ➔ 0 | Trial completion date: Sep 2025 ➔ Sep 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Jun 2025 ➔ Sep 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc. | Trial completion date: Jun 2023 ➔ Sep 2025

Trial completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Jun 2023 | Initiation date: Jun 2022 ➔ Sep 2022 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Study of Cysteamine-pantetheine Disulfide (TTI-0102) in Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Thiogenesis Therapeutics, Inc.

New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

TTI-0102 for Veterans With TBI (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: VA Office of Research and Development; N=42 ➔ 0; Trial completion date: Sep 2023 ➔ Oct 2021; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Sep 2023 ➔ Oct 2021

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • BDNF • CRP • IL6

TTI-0102 for Veterans With TBI (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: VA Office of Research and Development; Trial completion date: Jun 2022 ➔ Sep 2023; Trial primary completion date: Jun 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • BDNF • CRP • IL6

TTI-0102 for Veterans With TBI (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: VA Office of Research and Development; Initiation date: Jan 2021 ➔ Apr 2021

Trial initiation date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • BDNF • CRP • IL6

TTI-0102 for Veterans With TBI (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: VA Office of Research and Development; Trial completion date: Dec 2021 ➔ Jun 2022; Initiation date: Jul 2020 ➔ Jan 2021; Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • BDNF • CRP • IL6

TTI-0102 for Veterans With TBI (clinicaltrials.gov) - P1/2; N=42; Not yet recruiting; Sponsor: VA Office of Research and Development

New P1/2 trial