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- | Pam2CSK4/ODN-M362 / Pulmotect
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Apr 27, 2023
P1, N=0, Withdrawn, Sponsor: Pulmotect, Inc.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 Withdrawn | Trial primary completion date: Mar 2025 --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
- PUL-042 / Pulmotect
Safety and Pharmacodynamics of a Novel Inhaled Tlr Agonist Combination in Gold Stage 0 COPD Subjects During Experimental Rhinovirus Challenge (Marriott Marquis Washington, Marquis Ballroom, Salons 1-2 (Level M2)) - Mar 25, 2023 - Abstract #ATS2023ATS_3614;
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.
- Pam2CSK4/ODN-M362 / Pulmotect
Trial completion date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Apr 20, 2022
P1, N=18, Suspended, Sponsor: Pulmotect, Inc.
The data highlight the immunomodulatory effects of PUL-042, causing temporary changes in systemic and local immune biomarkers following inhalation. Trial completion date: May 2023 --> May 2025 | Trial primary completion date: Mar 2023 --> Mar 2025
- | PUL-042 / Pulmotect
Journal: Host-directed therapy in foals can enhance functional innate immunity and reduce severity of Rhodococcus equi pneumonia. (Pubmed Central) - Sep 16, 2021
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.
- |||| PUL-042 / Pulmotect
Trial completion: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Sep 2, 2021
P2, N=217, Completed, Sponsor: Pulmotect, Inc.
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. Active, not recruiting --> Completed
- PUL-042 / Pulmotect
[VIRTUAL] Inducible epithelial resistance modulates innate antiviral signaling against coronavirus and influenza () - Jul 29, 2021 - Abstract #ERS2021ERS_3117;
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.
- ||| PUL-042 / Pulmotect
Enrollment closed: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Jul 16, 2021
P2, N=217, Active, not recruiting, Sponsor: Pulmotect, Inc.
Inducible resistance by Pam2-ODN activated broad epithelial antiviral innate immune pathways while abrogating virus-specific signaling. Recruiting --> Active, not recruiting
- ||| Pam2CSK4/ODN-M362 / Pulmotect
Trial completion: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - Jul 16, 2021
P2, N=101, Completed, Sponsor: Pulmotect, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || Pam2CSK4/ODN-M362 / Pulmotect
Enrollment closed: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - Jun 18, 2021
P2, N=101, Active, not recruiting, Sponsor: Pulmotect, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || PUL-042 / Pulmotect
Trial completion: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Jun 1, 2021
P2, N=20, Completed, Sponsor: Pulmotect, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- || PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Jun 1, 2021
P2, N=200, Recruiting, Sponsor: Pulmotect, Inc.
Active, not recruiting --> Completed Trial completion date: Jun 2021 --> Sep 2021 | Trial primary completion date: May 2021 --> Aug 2021
- PUL-042 / Pulmotect
[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 () - Mar 14, 2021 - Abstract #ATS2021ATS_1430;
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.
- | PUL-042 / Pulmotect
Enrollment closed: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Mar 12, 2021
P2, N=20, Active, not recruiting, Sponsor: Pulmotect, Inc.
Additionally, the phosphorothioate modification of both ODN M362 and ODN A151 appears to enhance this viral clearance and warrants further mechanistic investigation. Recruiting --> Active, not recruiting
- Pam2CSK4/ODN-M362 / Pulmotect
Trial completion date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Mar 12, 2021
P1, N=18, Suspended, Sponsor: Pulmotect, Inc.
Recruiting --> Active, not recruiting Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- || PUL-042 / Pulmotect
Trial primary completion date: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Jan 13, 2021
P2, N=200, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: May 2022 --> May 2023 | Trial primary completion date: Mar 2022 --> Mar 2023 Trial primary completion date: Jan 2021 --> Apr 2021
- | PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Oct 19, 2020
P2, N=20, Recruiting, Sponsor: Pulmotect, Inc.
Trial primary completion date: Jan 2021 --> Apr 2021 Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021
- || PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Oct 19, 2020
P2, N=200, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021 Trial completion date: Nov 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021
- || Pam2CSK4/ODN-M362 / Pulmotect
Trial completion date, Trial primary completion date: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - Oct 19, 2020
P2, N=100, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Nov 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021 Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021
- | PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Sep 4, 2020
P2, N=20, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Oct 2020 --> Jan 2021 Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Oct 2020
- ||| PUL-042 / Pulmotect
Enrollment open: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Jun 4, 2020
P2, N=200, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Oct 2020 Not yet recruiting --> Recruiting
- ||||| PUL-042 / Pulmotect
P2 data: Thanks for your piece! Over 1,700 trials but only handful in mild #covid19 patients. PUL-042 Phase 2 trials underway in mild COVID-19. Has robust animal data against coronavirus; fingers crossed for human protection! @pulmotect @FanninStudio @ScottEvansMD @MDAndersonNews @TAMU (Twitter) - May 22, 2020
- ||||| PUL-042 / Pulmotect
P2 data: Thanks for your piece! Over 1,700 trials but only handful in mild #covid19 patients. PUL-042 Phase 2 trials underway in mild COVID-19. Has robust animal data against coronavirus; fingers crossed for human protection! @pulmotect @FanninStudio @ScottEvansMD @MDAndersonNews @TAMU (Twitter) - May 22, 2020
- ||| Pam2CSK4/ODN-M362 / Pulmotect
Enrollment open: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - May 11, 2020
P2, N=100, Recruiting, Sponsor: Pulmotect, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- PUL-042 / Pulmotect
Host-directed therapy in foals reduces the severity of clinical pneumonia against Rhodococcus equi intrabronchial challenge (Board Number: P1264) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_2673;
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.
- |||| PUL-042 / Pulmotect
Pulmotect just put PUL-042 (TLR 2/6/9 agonist??) into phase 2 for Covid-19 https://t.co/tEDnqhNaxv https://t.co/QK60EyO4o2 (Twitter) - Mar 19, 2020
- |||| PUL-042 / Pulmotect
New P2 trial: The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (clinicaltrials.gov) - Mar 18, 2020
P2, N=200, Not yet recruiting, Sponsor: Pulmotect, Inc.
- |||| Pam2CSK4/ODN-M362 / Pulmotect
New P2 trial: The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (clinicaltrials.gov) - Mar 18, 2020
P2, N=100, Not yet recruiting, Sponsor: Pulmotect, Inc.
- | PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Mar 6, 2020
P2, N=20, Recruiting, Sponsor: Pulmotect, Inc.
Our results show potential for enhancing neonatal immune responses against respiratory pathogens and reducing severity of clinical pneumonia following intrabronchial challenge with R. equi. Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Nov 2019 --> Jul 2020
- | PUL-042 / Pulmotect
Trial primary completion date: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Aug 28, 2019
P2, N=20, Recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Nov 2019 --> Jul 2020 Trial primary completion date: Jul 2019 --> Nov 2019
- PUL-042 / Pulmotect
Trial completion date, Trial initiation date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Mar 22, 2019
P1, N=18, Suspended, Sponsor: Pulmotect, Inc.
Trial primary completion date: Jul 2019 --> Nov 2019 Trial completion date: May 2020 --> May 2022 | Initiation date: Dec 2018 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Mar 2022
- || PUL-042 / Pulmotect
New P2 trial: The Effect of Inhaled PUL-042 on Rhinovirus-induced Symptoms in Smokers With GOLD Stage 0 COPD (clinicaltrials.gov) - Jan 7, 2019
P2, N=20, Recruiting, Sponsor: Pulmotect, Inc.
- | PUL-042 / Pulmotect
Trial initiation date, Trial suspension, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Sep 14, 2018
P1, N=18, Suspended, Sponsor: Pulmotect, Inc.
Trial completion date: May 2020 --> May 2022 | Initiation date: Dec 2018 --> Dec 2020 | Trial primary completion date: Mar 2020 --> Mar 2022 Initiation date: Aug 2018 --> Dec 2018 | Recruiting --> Suspended | Trial primary completion date: Dec 2019 --> Mar 2020
- | PUL-042 / Pulmotect
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Aug 16, 2018
P1, N=18, Recruiting, Sponsor: Pulmotect, Inc.
Initiation date: Aug 2018 --> Dec 2018 | Recruiting --> Suspended | Trial primary completion date: Dec 2019 --> Mar 2020 Not yet recruiting --> Recruiting | Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Dec 2019 | Initiation date: May 2018 --> Aug 2018
- PUL-042 / Pulmotect
Trial completion date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Apr 5, 2018
P1, N=18, Not yet recruiting, Sponsor: Pulmotect, Inc.
Not yet recruiting --> Recruiting | Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Dec 2019 | Initiation date: May 2018 --> Aug 2018 Trial completion date: Nov 2018 --> Nov 2019 | Trial primary completion date: Sep 2018 --> Sep 2019
- PUL-042 / Pulmotect
Trial initiation date, Trial primary completion date: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Aug 10, 2017
P1, N=18, Not yet recruiting, Sponsor: Pulmotect, Inc.
Trial completion date: Nov 2018 --> Nov 2019 | Trial primary completion date: Sep 2018 --> Sep 2019 Initiation date: Apr 2017 --> Sep 2017 | Trial primary completion date: Mar 2018 --> Sep 2018
- | PUL-042 / Pulmotect
New P1 trial: A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients (clinicaltrials.gov) - Mar 31, 2017
P1, N=18, Not yet recruiting, Sponsor: Pulmotect, Inc.
- | Pam2CSK4/ODN-M362 / Pulmotect
Trial completion: Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) (clinicaltrials.gov) - Oct 3, 2016
P1, N=16, Completed, Sponsor: Pulmotect, Inc.
Initiation date: Apr 2017 --> Sep 2017 | Trial primary completion date: Mar 2018 --> Sep 2018 Recruiting --> Completed
- | Pam2CSK4/ODN-M362 / Pulmotect
New P1 trial: Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) (clinicaltrials.gov) - Oct 2, 2015
P1, N=16, Recruiting, Sponsor: Pulmotect, Inc.
- Pam2CSK4/ODN-M362 / Pulmotect
Trial completion, Enrollment change: Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects (clinicaltrials.gov) - Apr 29, 2015
P1, N=42, Completed, Sponsor: Pulmotect, Inc.
Recruiting --> Completed Recruiting --> Completed | N=56 --> 42
- Pam2CSK4/ODN-M362 / Pulmotect
New P1 trial: Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects (clinicaltrials.gov) - Apr 24, 2014
P1, N=56, Recruiting, Sponsor: Pulmotect, Inc.