PUL-042 / Pulmotect - LARVOL DELTA

PUL-042-207: PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Pulmotect, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ May 2026 | Initiation date: Oct 2025 ➔ Apr 2025 | Trial primary completion date: Jan 2026 ➔ Apr 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

PUL-042 Treatment in Patients with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Pulmotect, Inc.

New P2 trial • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Oncology • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Safety and Pharmacodynamics of a Novel Inhaled Tlr Agonist Combination in Gold Stage 0 COPD Subjects During Experimental Rhinovirus Challenge (ATS 2023) - "PUL-042 treatment was well tolerated in actively smoking GOLD 0 COPD subjects. The data highlight the immunomodulatory effects of PUL-042, causing temporary changes in systemic and local immune biomarkers following inhalation."

Clinical • IO biomarker • PK/PD data • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • CXCL10 • IL6 • TLR2

A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Pulmotect, Inc. | N=18 ➔ 0 | Trial completion date: May 2025 ➔ May 2026 | Suspended ➔ Withdrawn | Trial primary completion date: Mar 2025 ➔ Mar 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - P1 | N=18 | Suspended | Sponsor: Pulmotect, Inc. | Trial completion date: May 2023 ➔ May 2025 | Trial primary completion date: Mar 2023 ➔ Mar 2025

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

[VIRTUAL] Inducible epithelial resistance modulates innate antiviral signaling against coronavirus and influenza (ERS 2021) - "PUL-042 is a therapeutic dyad of Toll-like receptor 2/6/9 agonists, Pam2CSK4 and ODN M362 (Pam2-ODN), that synergistically stimulate protective responses from lung epithelial cells against pneumonia-causing pathogens, such as Influenza (Kirkpatrick et al... Inducible resistance by Pam2-ODN activated broad epithelial antiviral innate immune pathways while abrogating virus-specific signaling."

Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=217; Completed; Sponsor: Pulmotect, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - P2; N=101; Completed; Sponsor: Pulmotect, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=217; Active, not recruiting; Sponsor: Pulmotect, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - P2; N=101; Active, not recruiting; Sponsor: Pulmotect, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: Pulmotect, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CXCL10 • IL6

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Pulmotect, Inc.; Trial completion date: Jun 2021 ➔ Sep 2021; Trial primary completion date: May 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Toll-Like Receptor 9 Toll/Interleukin-1R Domain-Mediated Signaling Is Dispensable in Inducible Resistance to Influenza A Infection in Human Bronchial Epithelial Cells (ATS 2021) - " Human bronchial epithelial cells (HBEC3-KT) were grown to 80% confluence and then pretreated with Pam2CSK4/ODN M362 +/- TLR9 inhibitory ODN A151 (2:1 A151:M362) with either a phosphorothioate or phosphodiester backbone for four hours... The use of Pam2/ODN reduces IAV gene expression and viral burden in HBEC3-KT cells. This reduction appears to be independent of canonical TIR domain-mediated TLR9 signaling, though additional confirmatory experiments are required. Additionally, the phosphorothioate modification of both ODN M362 and ODN A151 appears to enhance this viral clearance and warrants further mechanistic investigation."

IO biomarker • Infectious Disease • Respiratory Diseases • CXCL10 • IL1B • MYD88 • TLR9

A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - P1; N=18; Suspended; Sponsor: Pulmotect, Inc.; Trial completion date: May 2022 ➔ May 2023; Trial primary completion date: Mar 2022 ➔ Mar 2023

Clinical • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Pulmotect, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • CXCL10 • IL6

Host-directed therapy in foals can enhance functional innate immunity and reduce severity of Rhodococcus equi pneumonia. (PubMed, Sci Rep) - "Foals infected and nebulized with PUL-042 or vehicle alone had a shorter duration of clinical signs of pneumonia and smaller pulmonary lesions when compared to non-nebulized foals. Our results demonstrate that host-directed therapy can enhance neonatal immune responses against respiratory pathogens and reduce the duration and severity of R. equi pneumonia."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Pulmotect, Inc.; Trial primary completion date: Jan 2021 ➔ Apr 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Pulmotect, Inc.; Trial completion date: Dec 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Pulmotect, Inc.; Trial completion date: Dec 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Pulmotect, Inc.; Trial completion date: Nov 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Jan 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Pulmotect, Inc.; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Pulmotect, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

St. Elizabeth Healthcare partners with CTI and Pulmotect becoming first hospital site for phase-2 clinical trial targeting Covid-19 (PRNewswire) - "St. Elizabeth Healthcare has been selected as the first site of the FDA-approved Phase-2 COVID-19 clinical trial studying the drug PUL-042 of Pulmotect, Inc., in partnership with CTI Clinical Trial and Consulting Services (CTI)....The clinical trial will study the safety and efficacy of PUL-042....Trial is active and will be conducted at up to 10 clinical sites throughout the country, starting with St. Elizabeth in Northern Kentucky, the first hospital site in the world to be able to start dosing patients."

Clinical • Trial status • Infectious Disease • Novel Coronavirus Disease

Host-directed therapy in foals reduces the severity of clinical pneumonia against Rhodococcus equi intrabronchial challenge (IMMUNOLOGY 2020) - "Infected foals nebulized with PUL-042 had a shorter duration of clinical signs of pneumonia and of presence of lung abscesses when compared to foals that did not receive nebulization, consistent with our ex vivo findings. Our results show potential for enhancing neonatal immune responses against respiratory pathogens and reducing severity of clinical pneumonia following intrabronchial challenge with R. equi."

Clinical • IFNG • IL6

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Pulmotect, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease