IMCY-0098 / Imcyse - LARVOL DELTA

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P2 | N=110 | Terminated | Sponsor: Imcyse SA | Trial completion date: Jan 2025 ➔ May 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Jan 2024; No efficacy at primary analysis after 1 year. Long term follow-up stopped

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

First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers. (PubMed, BMC Med) - P1 | "Promising preliminary efficacy results support the design of a phase 2 study of IMCY-0098 in patients with recent-onset T1D."

Biomarker • Clinical • IO biomarker • Journal • P1 data • P1 data • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Imcyse SA | Phase classification: P2a ➔ P2

Phase classification • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. (PubMed, BMC Med) - P1 | "Promising safety profile and preliminary clinical response data support the design of a phase 2 study of IMCY-0098 in patients with recent-onset T1D."

Journal • P1 data • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P2a | N=110 | Active, not recruiting | Sponsor: Imcyse SA | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2024 ➔ Jan 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P2a | N=108 | Recruiting | Sponsor: Imcyse SA | Trial completion date: Apr 2023 ➔ Sep 2024 | Trial primary completion date: Apr 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P2a; N=84; Recruiting; Sponsor: Imcyse SA; Phase classification: P1/2 ➔ P2a

Clinical • Phase classification • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P1/2; N=84; Recruiting; Sponsor: Imcyse SA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

[VIRTUAL] Long-term follow-up study of type 1 diabetes patients previously treated with IMCY-0098 or placebo in young adults with recent-onset type 1 diabetes (EASD 2020) - P1 | "Results of this LTFU clinical trial have confirmed the excellent safety profile of IMCY-0098 observed in the IMCY-T1D-001 study, reaching the primary study objective. The positive trend in clinical and immunological parameters improvement detected in the main study was not observed in the LTFU. The current data suggest that the right dosage or regimen (number and timing of injections of IMCY-0098) to elicit a significant and long-term effect is yet to be identified."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study) (clinicaltrials.gov) - P1/2; N=84; Not yet recruiting; Sponsor: Imcyse SA

New P1/2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Imcyse SA; Recruiting ➔ Completed

Clinical • Trial completion

IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo (clinicaltrials.gov) - P1; N=41; Recruiting; Sponsor: Imcyse SA

Clinical • New P1 trial

Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes (clinicaltrials.gov) - P1; N=41; Completed; Sponsor: Imcyse SA; Active, not recruiting ➔ Completed; Trial completion date: Apr 2019 ➔ Aug 2019

Clinical • Trial completion • Trial completion date

Phase Ib clinical trial of IMCY-0098 in young adults with recent-onsent type 1 diabetes (EASD 2019) - P1; "Preliminary safety data suggest that IMCY-0098 is safe in patients with recent onset T1D. Currently, the clinical study is still blinded. Full study results will be available and presented at the EASD 2019."

Clinical • P1 data