IDL-2965 / St. Louis University, Indalo Therap - LARVOL DELTA

Combined application of biosponges and an anti-fibrotic agent for the treatment of volumetric muscle loss. (PubMed, Am J Physiol Cell Physiol) - "The reduction in fibrotic tissue had no detrimental effects on muscle mass, function, size, or vascularity. Overall, these findings suggest that the co-delivery of biosponges and IDL-2965 is a safe and effective strategy for the mitigation of fibrotic tissue deposition in VML-injured muscles."

Journal • Fibrosis • Immunology

[VIRTUAL] TARGET ENGAGEMENT AND ANTI-FIBROTIC ACTIVITY OF THE INTEGRIN ANTAGONIST IDL-2965 IN A MOUSE MODEL OF NON-ALCOHOLIC STEATOHEPATITIS (AASLD 2020) - "Increased expression of integrin avb3 and strong target engagement by IDL-2965 in the CDAHFD-induced NASH model can be detected in vivo using the integrin-binding PET tracer 18F-FPPRGD2. Consistent with strong target engagement, therapeutic administration of IDL-2965 significantly reduced multiple measures of CDAHFD-induced hepatic fibrosis."

Preclinical • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis • MRI

[VIRTUAL] Plasma MFGE8 concentrations rapidly respond to single doses of the antifibrotic integrin antagonist IDL-2965 in healthy volunteers (HVs) (ERS 2020) - "Single dose IDL-2965 resulted in robust, rapid and dose-dependent increases in plasma MFGE8, a known ligand of integrin avB3. Plasma MFGE8 may serve as a novel marker of target engagement and help inform dose selection for IDL-2965. Final data including exposure-response modelling will be presented."

Clinical • Fibrosis • Interstitial Lung Disease • Respiratory Diseases

[VIRTUAL] Pharmacokinetics (PK) and Safety of the Antifibrotic Drug IDL-2965 in a Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Volunteers (HV) Compared to Therapeutic Plasma Concentrations in the Bleomycin Mouse Model of Lung Fibrosis (ATS-I 2020) - "Favorable safety results were observed in HVs with exposures that were within and above the bleomycin model therapeutic range. Patient dosing is ongoing in the biomarker-driven IPF MAD part of this study."

PK/PD data • Fibrosis • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Liver Cirrhosis • Respiratory Diseases

A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis (clinicaltrials.gov) - P1; N=6; Terminated; Sponsor: Indalo Therapeutics, Inc.; N=120 ➔ 6; Recruiting ➔ Terminated; Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data

Enrollment change • Trial termination • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

[VIRTUAL] IDL-2965: a selective, highly potent, clinical-stage integrin antagonist for treatment of non-alcoholic steatohepatitis (EASL-ILC-I 2020) - No abstract available

Clinical • Hepatology • Immunology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Pharmacokinetics (PK) and Safety of the Antifibrotic Drug IDL-2965 in a Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Volunteers (HV) Compared to Therapeutic Plasma Concentrations in the Bleomycin Mouse Model of Lung Fibrosis (ATS 2020) - "Favorable safety results were observed in HVs with exposures that were within and above the bleomycin model therapeutic range. Patient dosing is ongoing in the biomarker-driven IPF MAD part of this study."

PK/PD data

Idl-2965: a selective, highly potent, clinical-stage integrin antagonist for treatment of nonalcoholic steatohepatitis (EASL-ILC 2020) - No abstract available

Clinical

IDL-2965: A SELECTIVE, HIGHLY POTENT, CLINICAL-STAGE INTEGRIN ANTAGONIST FOR THE TREATMENT OF NASH (AASLD 2019) - "IDL-2965 potently suppresses fibrosis and related biomarkers in preclinical models of liver fibrosis and its characterization in an ongoing phase 1 program including NASH patients is warranted."

Clinical

Indalo Therapeutics presents phase 1 clinical trial results for lead antifibrotic drug candidate IDL-2965 (PRNewswire) - P1, N=120; NCT03949530; Sponsor: Indalo Therapeutics, Inc.; "Indalo Therapeutics...for the first time presented clinical data for...IDL-2965 at the Pulmonary Fibrosis Foundation (PFF) Summit on November 7. The data demonstrate excellent safety and tolerability at concentrations that are multiples of those anticipated to be necessary for efficacy, as well as strong oral pharmacokinetics supportive of once-daily oral dosing....Dosing is ongoing in the third part of the protocol, a 28-day MAD study in IPF patients designed to measure safety, pharmacokinetics, and effects on a robust panel of target-engagement and disease biomarkers."

P1 data • Trial status

Indalo Therapeutics initiates dosing in IPF patients with lead antifibrotic drug candidate IDL-2965 (PRNewswire) - "Indalo Therapeutics...today announced that the first IPF patient has been dosed in a clinical trial of the company's lead drug candidate IDL-2965....Indalo recently completed the first two parts of the protocol: single- and multiple-ascending dose (MAD) studies in normal healthy volunteers (NHVs)....Indalo plans to present data from the NHV studies at the Pulmonary Fibrosis Foundation (PFF) Summit in November."

P1 data • Trial status

IDL-2965: A Selective, highly-potent, oral Integrin antagonist for IPF (ERS 2019) - "In a bleomycin model of pulmonary fibrosis, therapeutic dosing of 0.4 mg/kg significantly reduced fibrosis and combination studies with pirfenidone suggest compatibility with current standard of care. IDL-2965 is a selective integrin antagonist with significant antifibrotic effect at low, once-daily, oral doses and a favorable safety profile in formal toxicology and safety pharmacology studies. Based on these results a clinical study examining IDL-2965 in healthy subjects and IPF patients will commence in 2019."