tanimilast (CHF6001) / Chiesi 
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 9 Diseases   4 Trials   4 Trials   90 News 


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  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Anti-inflammatory Effects of Tanimilast in Two Murine House Dust Mite (HDM)-driven Models of Asthma (San Diego Convention Center, Area I (Hall H, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_4351;    
    P2, P3
    001). Overall, these data demonstrate that tanimilast is able to modulate both Th2 and non Th2 inflammation as well as AHR in asthma models including where ICS is not effective, suggesting that it could be a relevant therapy for asthmatic patients poorly controlled by ICS.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Trial completion date, Trial primary completion date:  A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp (clinicaltrials.gov) -  Sep 5, 2023   
    P3,  N=3980, Recruiting, 
    The possible implications for the treatment of respiratory disorders (such as COPD, asthma and COVID-19) by PDE4 inhibitors will be discussed. Trial completion date: Aug 2025 --> Sep 2027 | Trial primary completion date: Jul 2025 --> Sep 2027
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    The inhaled PDE4 inhibitor tanimilast shows efficacy in both Th2 and non-Th2 murine models of asthma (Red 1+2) -  Jun 17, 2023 - Abstract #ERS2023ERS_4190;    
    Imaging; Pulmonary function testing; Cell and molecular biology; Physiology; Respiratory intensive care Endoscopy and interventional pulmonology; Imaging; Pulmonary function testing; Pulmonary rehabilitation; Transplantation; General respiratory patient care; Physiology; Cell and molecular biology
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Trial completion, Trial completion date, Trial primary completion date:  PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers (clinicaltrials.gov) -  Jan 26, 2023   
    P1,  N=44, Completed, 
    Testing of this biomarker in other datasets is warranted. Recruiting --> Completed | Trial completion date: Aug 2023 --> Dec 2022 | Trial primary completion date: Aug 2023 --> Dec 2022
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Trial completion date, Trial primary completion date:  A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp (clinicaltrials.gov) -  Oct 25, 2022   
    P3,  N=3980, Recruiting, 
    Recruiting --> Completed | Trial completion date: Aug 2023 --> Dec 2022 | Trial primary completion date: Aug 2023 --> Dec 2022 Trial completion date: Sep 2024 --> Aug 2025 | Trial primary completion date: Sep 2024 --> Jul 2025
  • ||||||||||  ensifentrine (RPL554) / Verona Pharma, Daliresp (roflumilast) / AstraZeneca, Takeda, AbbVie, tanimilast (CHF6001) / Chiesi
    Review, Journal:  Can Phosphodiesterase 4 Inhibitor Therapy Be Used in Respiratory Diseases Other Than Chronic Obstructive Pulmonary Disease? (Pubmed Central) -  Aug 27, 2022   
    Roflumilast is not approved for the treatment of asthma due to associated adverse effects and comparable efficacy to inhaled corticosteroids, which are considered the mainstay of asthma maintenance therapy...Tanimilast (CHF6001), an inhalational selective PDE4 inhibitor, and ensifentrine, a combined PDE3/4 inhibitor, demonstrate the recent therapeutic success in asthma and warrant further large-scale clinical studies...Current evidence suggests the possibility of PDE4 inhibitors as a novel therapeutic option for chronic cough, allergic rhinitis, and cystic fibrosis. Further evidence from new studies is eagerly anticipated to better understand the efficacy and safety of PDE4 inhibitors in these respiratory diseases.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    THE PDE4 INHIBITOR TANIMILAST SHOWS DISTINCT IMMUNOMODULATORY PROPERTIES ASSOCIATED WITH A TYPE 2 ENDOTYPE AND CD141 UPREGULATION (8N) -  Jun 22, 2022 - Abstract #ERS2022ERS_2202;    
    Notably, these same genes were found upregulated also in sputum cells of COPD patients treated with tanimilast as add-on to inhaled glucocorticoids and bronchodilators in a randomized placebo-controlled trial. Taken together, these findings demonstrate distinct immunomodulatory properties of tanimilast associated with a type-2 endotype and CD141 upregulation in DCs and provide a mechanistic rationale supporting the use of tanimilast as non redundant add on therapy on top of inhaled corticosteroids.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Journal:  The PDE4 Inhibitor Tanimilast Restrains the Tissue-Damaging Properties of Human Neutrophils. (Pubmed Central) -  May 21, 2022   
    In contrast, it promoted neutrophil survival by decreasing both spontaneous apoptosis and cell death in the presence of pro-survival factors. The present work suggests that tanimilast can alleviate the severe tissue damage caused by massive recruitment and activation of neutrophils in inflammatory diseases such as COPD.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Journal, IO biomarker:  The PDE4 inhibitor tanimilast shows distinct immunomodulatory properties associated with a type 2 endotype and CD141 upregulation. (Pubmed Central) -  May 18, 2022   
    The present work suggests that tanimilast can alleviate the severe tissue damage caused by massive recruitment and activation of neutrophils in inflammatory diseases such as COPD. Taken together, these findings demonstrate distinct immunomodulatory properties of tanimilast associated with a type 2 endotype and CD141 upregulation in DCs and provide a mechanistic rationale for the administration of tanimilast on top of inhaled corticosteroids.
  • ||||||||||  ensifentrine (RPL554) / Verona Pharma, Daliresp (roflumilast) / AstraZeneca, Takeda, AbbVie, tanimilast (CHF6001) / Chiesi
    Journal:  Inhaled Phosphodiesterase Inhibitors for the Treatment of Chronic Obstructive Pulmonary Disease. (Pubmed Central) -  Feb 23, 2022   
    These inhaled PDE inhibitors have both reported positive findings from early phase clinical trials, and have been well tolerated. Longer term trials are needed to firmly establish the clinical benefits of these drugs.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Journal:  The PDE4 Inhibitor Tanimilast Blunts Proinflammatory Dendritic Cell Activation by SARS-CoV-2 ssRNAs. (Pubmed Central) -  Feb 17, 2022   
    Our results indicate that Tanimilast can modulate the SCV2-RNA-induced pro-inflammatory and Th1-polarizing potential of DCs, crucial regulators of both the inflammatory and immune response. Given also the remarkable safety demonstrated by Tanimilast, up to now, in clinical studies, we propose this inhaled PDE4 inhibitor as a promising immunomodulatory drug in the scenario of COVID-19.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Review, Journal:  Tanimilast, A Novel Inhaled Pde4 Inhibitor for the Treatment of Asthma and Chronic Obstructive Pulmonary Disease. (Pubmed Central) -  Dec 13, 2021   
    Inhaled tanimilast has reached phase III clinical development by showing promising pharmacodynamic results associated with a good tolerability and safety profile, with no evidence of PDE4 inhibitors class-related side effects. In this review we will discuss the main outcomes of preclinical and clinical studies conducted during tanimilast development, with particular emphasis on the characterization of the pharmacodynamic profile that led to the identification of target populations with increased therapeutic potential in inflammatory respiratory diseases.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Journal:  Discovery of M Antagonist-PDE4 Inhibitor Dual Pharmacology Molecules for the Treatment of Chronic Obstructive Pulmonary Disease. (Pubmed Central) -  Sep 9, 2021   
    The identification of dual compounds was enabled by the intuition that the fusion of a PDE4 scaffold derived from our CHF-6001 series with a muscarinic scaffold through a common linking ring could generate compounds active versus both the transmembrane M receptor and the intracellular PDE4 enzyme...SAR optimization was aimed at obtaining M nanomolar affinity coupled with nanomolar PDE4 inhibition, which translated into anti-bronchospastic efficacy ex vivo (inhibition of rat trachea contraction) and into anti-inflammatory efficacy in vitro (inhibition of TNFα release). Among the best compounds, compound 92a achieved the goal of demonstrating in vivo efficacy and duration of action in both the bronchoconstriction and inflammation assays in rat after intratracheal administration.
  • ||||||||||  tanimilast (CHF6001) / Chiesi
    Clinical, Journal:  Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. (Pubmed Central) -  Aug 4, 2021   
    P2
    CHF6001 had no effect in the primary lung function analysis, although was well-tolerated with no gastrointestinal adverse event signal. Post-hoc analyses focused on exacerbation risk indicate specific patient subgroups who may receive particular benefit from CHF6001.
  • ||||||||||  ensifentrine (RPL554) / Verona Pharma, Daliresp (roflumilast) / AstraZeneca, Takeda, AbbVie, tanimilast (CHF6001) / Chiesi
    Review, Journal:  Role of phosphodiesterase-4 inhibitors in chronic obstructive pulmonary disease. (Pubmed Central) -  Jun 26, 2021   
    An inhaled PDE4I has recently been developed and is under clinical trial. CHF6001 and RPL554 exhibit promise and may be future treatment options for COPD.
  • ||||||||||  ensifentrine (RPL554) / Verona Pharma, tanimilast (CHF6001) / Chiesi
    Review, Journal:  New Avenues for Phosphodiesterase Inhibitors in Asthma. (Pubmed Central) -  Mar 25, 2021   
    CHF 6001 and RPL554 are the only molecules that currently are under clinical development but there are several new agents with interesting pharmacological profiles. It will be stimulating to assess the impact of such agents on individual treatable traits in specially designed studies.
  • ||||||||||  CHF6001 / Chiesi
    Journal:  The PDE4 inhibitor CHF6001 affects keratinocyte proliferation via cellular redox pathways. (Pubmed Central) -  Jul 16, 2020   
    Furthermore, CHF6001 decreased oxidative stress, measured by assessing lipid peroxidation (4-HNE adduct formation), through the inactivation of the NADPH oxidase. These results suggest that CHF6001 has the potential to treat skin disorders associated with hyperproliferative keratinocytes, such as psoriasis by targeting oxidative stress, abnormal re-epithelization, and inflammation.
  • ||||||||||  CHF6001 / Chiesi
    Biomarker, Journal:  Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD. (Pubmed Central) -  Feb 7, 2020   
    P2
    This pharmacological effect suggests the therapeutic potential for PDE4 inhibitors to be used in the subset of more severe asthma patients with increased airway levels of IFNγ. The data from this study show that CHF6001 inhaled twice daily has anti-inflammatory effects in the lungs of patients with COPD already treated with triple inhaled therapy.
  • ||||||||||  CHF6001 / Chiesi
    Preclinical, Journal:  CHF6001 Inhibits NF-κB Activation and Neutrophilic Recruitment in LPS-Induced Lung Inflammation in Mice. (Pubmed Central) -  Dec 8, 2019   
    LPS-induced an increase of BLI signal in NF-κB-luc mice, and CHF6001 administered by dry powder inhalation decreased in parallel luciferase signal, cell airway infiltration, and pro-inflammatory cytokine concentrations in BALF. The results obtained provide in vitro and in vivo evidence of the anti-inflammatory activity of the potent PDE4 inhibitor CHF6001, showing that with a topical administration that closely mimics inhalation in humans, it efficiently disrupts the NF-κB activation associated with LPS challenge, an effect that may be relevant for the prevention of exacerbation episodes in chronic obstructive pulmonary disease subjects.