OPT101 / Op-T - LARVOL DELTA

A New Drug, Opt101, Reduced Inflammatory Biomarkers In Type 1 Diabetes Type 1a And Stimulated C-peptide In 2 Undetectable Subjects (ENDO 2025) - "The data support that elevated Th40 levels, IFNγ, and TNFα differentiate Type 1A and 1B diabetes and that regulating CD40 - CD154 interaction protects and possibly restores, beta cell function. An increase in C-peptide in people with T1D at baseline C-peptide (0.1 ng/L, no residual C-peptide) has not been reported previously and was only achieved with OPT101 treatment."

Biomarker • Clinical • IO biomarker • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 1 Diabetes Mellitus • CD40 • CD40LG • IFNG • TNFA

A New Drug, Opt101, Reduced Inflammatory Biomarkers In Type 1 Diabetes Type 1a And Stimulated C-peptide In 2 Undetectable Subjects (ENDO 2025) - "The data support that elevated Th40 levels, IFNγ, and TNFα differentiate Type 1A and 1B diabetes and that regulating CD40 - CD154 interaction protects and possibly restores, beta cell function. An increase in C-peptide in people with T1D at baseline C-peptide (0.1 ng/L, no residual C-peptide) has not been reported previously and was only achieved with OPT101 treatment."

Biomarker • Clinical • IO biomarker • Late-breaking abstract • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 1 Diabetes Mellitus • CD40 • CD40LG • IFNG • TNFA

Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Op-T LLC

New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Op-T LLC | Initiation date: Feb 2025 ➔ Jun 2025

Trial initiation date • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

OPT101 in Patients with Community Acquired Pneumonia (CAP) with Sepsis (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Op-T LLC

New P1 trial • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

CD40 Costimulatory Inhibition Modulates Immune Inflammation in Human Septic Peripheral Blood Mononuclear Cells (ATS 2024) - "Acute inflammation that occurs during sepsis causes a significant increase in Th40 cells, pathogenic effector cells associated with chronic inflammation, even in lymphopenia conditions. PBMC and Th40 cells specifically harbor significantly higher levels of inflammatory cytokines upon isolation, demonstrating a pre-existing activated status. Targeting CD40 using a new drug (currently completing Phase 1b clinical trials), OPT101, reduces but does not ablate inflammatory cytokines."

IO biomarker • Infectious Disease • Inflammation • Septic Shock • CD40 • CSF2 • IFNG • IL6 • TNFA

1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide. (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Op-T LLC | Active, not recruiting ➔ Recruiting | Phase classification: P1a/1b ➔ P1 | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Enrollment open • Phase classification • Trial completion date • Trial primary completion date

OPT101 in Type 1 Diabetes Patients (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Op-T LLC | Recruiting ➔ Completed | Phase classification: P1b ➔ P1 | Trial completion date: Aug 2023 ➔ Feb 2024 | Trial primary completion date: Aug 2023 ➔ Feb 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

OPT101 in Type 1 Diabetes Patients (clinicaltrials.gov) - P1b | N=18 | Recruiting | Sponsor: Op-T LLC | Trial completion date: Oct 2022 ➔ Aug 2023 | Trial primary completion date: Oct 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

1a/1b Study of OPT101 First in Human Study Assessing Safety and Tolerability of 15-mer Peptide. (clinicaltrials.gov) - P1a/1b | N=15 | Active, not recruiting | Sponsor: Op-T LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2021 ➔ Jun 2023 | Trial primary completion date: Sep 2021 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date

OPT101 in Type 1 Diabetes Patients (clinicaltrials.gov) - P1b | N=18 | Recruiting | Sponsor: Op-T LLC | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2022 ➔ Sep 2022

Enrollment open • Trial initiation date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

OPT101 in Type 1 Diabetes Patients (clinicaltrials.gov) - P1b | N=18 | Not yet recruiting | Sponsor: Op-T LLC

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus