LTI-01 / Rein Therapeutics - LARVOL DELTA

The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions. (PubMed, Respir Res) - P2 | "No statistically significant difference in the incidence of treatment failure was seen, potentially related to low recruitment. Trends towards efficacy were observed in predetermined sensitivity analyses at the 400,000 U dose of intrapleural LTI-01. Pleural opacification appeared most improved by the 800,000 U intrapleural LTI-01. A larger phase 2b trial is required to confirm these results or determine the efficacy of LTI-01 in patients with organizing, nondraining, infected pleural effusions."

Clinical • Journal • P2a data • Pleural effusion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Aileron Therapeutics Announces Rebranding to Rein Therapeutics (PRNewswire) - "2025 Strategic Objectives and Anticipated Milestones: LTI-03: A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year."

New P2 trial • Idiopathic Pulmonary Fibrosis

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2 | N=44 | Completed | Sponsor: Lung Therapeutics, Inc | Recruiting ➔ Completed | N=160 ➔ 44

Enrollment change • Trial completion • Respiratory Diseases

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2; N=160; Recruiting; Sponsor: Lung Therapeutics, Inc; Trial completion date: Mar 2022 ➔ Sep 2022

Clinical • Trial completion date • Respiratory Diseases

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2; N=160; Recruiting; Sponsor: Lung Therapeutics, Inc; Trial primary completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial primary completion date • Respiratory Diseases

Phase 1 trial of intrapleural LTI-01; single chain urokinase in complicated parapneumonic effusions or empyema. (PubMed, JCI Insight) - "LTI-01 IPFT was well-tolerated at these doses with no safety concerns. Bioactivity of LTI-01 IPFT was confirmed, limited to PFs where its processing simulated that previously reported in preclinical studies. Preliminary efficacy signals including reduction of pleural opacity were observed."

Journal • P1 data • Fibrosis • Immunology • Infectious Disease • Septic Shock

[VIRTUAL] Retrospective Validation of a Prototype a Point of Care Test to Personalize Intrapleural Fibrinolytic Therapy for Empyema (ATS-I 2020) - "Our proprietary assay successfully predicted outcomes of fibrinolytic therapy from patients enrolled in the phase I LTI01 trial and should be verified further in retrospective and prospective clinical trials. Studies of additional patients resistant to IPFT with tPA/DNase are needed to better understand the basis for the difference between the two MIST2 groups. A rapid, portable, iteration of the FP could yield a POC test amenable to validation in future clinical trial testing."

Retrospective data

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2; N=160; Recruiting; Sponsor: Lung Therapeutics, Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: Lung Therapeutics, Inc; N=100 ➔ 160; Trial completion date: Jun 2021 ➔ Mar 2022; Initiation date: Mar 2020 ➔ Jun 2020; Trial primary completion date: Dec 2020 ➔ Aug 2021

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date

A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Lung Therapeutics, Inc

Clinical • New P2 trial