MIB-626 / Metro International Biotech - LARVOL DELTA

Sirtuin-NAD Activator in Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • Aβ42 • CHI3L1 • CSF Aβ42 • GFAP

Phase 2a MIB-626 vs. Placebo COVID-19 (clinicaltrials.gov) - P2 | N=42 | Completed | Sponsor: Metro International Biotech, LLC | Recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • CST3

Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Metro International Biotech, LLC | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2023 ➔ Oct 2023

Enrollment open • Trial initiation date

NAD+ Precursor Supplementation in Friedreich's Ataxia (clinicaltrials.gov) - P2a | N=7 | Completed | Sponsor: Metro International Biotech, LLC | Active, not recruiting ➔ Completed | N=10 ➔ 7

Enrollment change • Trial completion • Ataxia • Congestive Heart Failure • Friedreich ataxia • Movement Disorders

Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Metro International Biotech, LLC | Phase classification: P1 ➔ P2

Phase classification

Effects of MIB-626 With and Without A High-Intensity Multi-Dimensional Exercise Training Program (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Metro International Biotech, LLC

New P1 trial

"I think MIB626 Will solve the Alzheimer's issue." (@xrpnft_s)

Alzheimer's Disease • CNS Disorders

DKD: NAD Augmentation in Diabetes Kidney Disease (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • IL6 • KIM1 • TNFA • TNFRSF1A

Phase 2a MIB-626 vs. Placebo COVID-19 (clinicaltrials.gov) - P2a | N=50 | Recruiting | Sponsor: Metro International Biotech, LLC | Trial completion date: Aug 2022 ➔ Aug 2023 | Trial primary completion date: Apr 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • CRP • CST3 • IL6 • KIM1 • TNFA

DKD: NAD Augmentation in Diabetes Kidney Disease (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: Brigham and Women's Hospital

New P2 trial • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • IL6 • KIM1 • TNFA • TNFRSF1A

Nicotinamide Adenine Dinucleotide Augmentation in Overweight or Obese Middle-Aged and Older Adults: A Physiologic Study. (PubMed, J Clin Endocrinol Metab) - "MIB-626 administration in overweight or obese, middle-aged and older adults safely increased circulating NAD levels, and significantly reduced total LDL and non-HDL cholesterol, body weight, and diastolic blood pressure. These data provide the rationale for larger trials to assess the efficacy of NAD augmentation in improving cardiometabolic outcomes in older adults."

Journal • Dyslipidemia • Obesity

NAD+ Precursor Supplementation in Friedreich's Ataxia (clinicaltrials.gov) - P2a | N=10 | Active, not recruiting | Sponsor: Metro International Biotech, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2022

Enrollment closed • Trial completion date • Trial primary completion date • Ataxia • Congestive Heart Failure • Friedreich ataxia • Movement Disorders

Sirtuin-NAD Activator in Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Dementia • IGF1 • IL6 • TNFA

NAD+ Precursor Supplementation in Friedreich's Ataxia (clinicaltrials.gov) - P2a | N=10 | Recruiting | Sponsor: Metro International Biotech, LLC | Trial completion date: Apr 2023 ➔ Sep 2023 | Trial primary completion date: Apr 2022 ➔ Sep 2022

Trial completion date • Trial primary completion date • Ataxia • Congestive Heart Failure • Friedreich ataxia • Movement Disorders

MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-aged and Older Adults. (PubMed, J Gerontol A Biol Sci Med Sci) - "MIB-626 1000-mg once daily or twice daily regimens were safe and associated with substantial dose-related increases in blood NAD levels and its metabolome. These data obtained using a pharmaceutical grade βNMN, standardized sample collection, and validated LC-MS/MS assays, should facilitate design of efficacy trials in disease conditions."

Journal • Obesity

Phase 2a MIB-626 vs. Placebo COVID-19 (clinicaltrials.gov) - P2a; N=50; Recruiting; Sponsor: Metro International Biotech, LLC; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • CRP • CST3 • IL6 • KIM1 • TNFA

Sirtuin-NAD Activator in Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=50; Not yet recruiting; Sponsor: Brigham and Women's Hospital; Trial primary completion date: Jun 2024 ➔ Feb 2024

Trial primary completion date • Alzheimer's Disease • CNS Disorders • Dementia • IGF1 • IL6 • TNFA

Sirtuin-NAD+ Activator in Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=50; Not yet recruiting; Sponsor: Brigham and Women's Hospital

New P1/2 trial • Alzheimer's Disease • CNS Disorders • Dementia • IGF1 • IL6 • TNFA

Phase 2a MIB-626 vs. Placebo COVID-19 (clinicaltrials.gov) - P2a; N=50; Not yet recruiting; Sponsor: Metro International Biotech, LLC

Clinical • New P2a trial • Acute Kidney Injury • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • CRP • CST3 • IL6 • KIM1 • TNFA

NAD+ Precursor Supplementation in Friedreich's Ataxia (clinicaltrials.gov) - P2a; N=10; Recruiting; Sponsor: Metro International Biotech, LLC

New P2a trial • Ataxia • Congestive Heart Failure • Friedreich ataxia • Movement Disorders