MDI-2517 / MDI Therap - LARVOL DELTA

Single Ascending Dose and Multiple Ascending Dose Evaluation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: MDI Therapeutics, Inc.

New P1 trial

Targeting Plasminogen Activator Inhibitor-1 with a Novel Small Molecule Inhibitor Attenuates Lung Fibrosis. (PubMed, Res Sq) - "Furthermore, we found that MDI-2517 treatment beginning on day 21 after lung injury accelerates fibrosis resolution while in vitro data reveal that this drug reverses myofibroblast differentiation. These results motivate targeting PAI-1 as a therapy for lung fibrosis and highlight MDI-2517 as a promising drug."

Journal • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: MDI Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion

A Potent Inhibitor of PAI-1, MDI-2517, Mitigates Disease Severity in Preclinical Models of Systemic Sclerosis (ACR Convergence 2024) - "Finally, a causal role for PAI-1 in fibrosis progression was examined in a preclinical model of SSc where bleomycin was administered subcutaneously via an osmotic pump for 7 days to induce systemic fibrosis followed by treatment for 21 days with the potent PAI-1 inhibitor MDI-2517...Treatment with MDI-2517 significantly reduced fibrosis in both the skin and lungs, and was superior to treatment with either pirfenidone or mycophenolate mofetil (MMF)... These findings highlight the role of PAI-1 in the pathogenesis of SSc, and the potential of MDI-2517 for the treatment of SSc. Based on these promising preclinical studies and standard non-clinical toxicology and safety pharmacology studies a Phase 1 first in human clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of MDI-2517 is currently underway. The results of the phase 1 study will inform the continued development of MDI-2517 for the potential treatment of SSc and interstitial..."

Preclinical • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • ACTA2 • SERPINE1

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: MDI Therapeutics, Inc. | N=48 ➔ 64 | Trial completion date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Enrollment change • Trial completion date • Trial primary completion date

SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: MDI Therapeutics, Inc.

New P1 trial