Respiratory - September 2020

Respiratory - September 2020

Knopp Biosciences completes patient enrollment for dexpramipexole’s Phase 2 trial in patients with moderate to severe eosinophilic Asthma

16 Sep 2020

Dexpramipexole (KNS-760704, Eosinophil depletion) – Knopp Biosciences

  • Knopp Biosciences completed the patient enrollment to its Phase 2 trial evaluating oral dexpramipexole in patients with moderate-to-severe eosinophilic Asthma
  • Trial objective: To study the effects of three dose levels of oral dexpramipexole for 12 weeks
  • Primary endpoint: change in peripheral blood eosinophil count
  • Secondary endpoint: changes in pre-bronchodilator FEV1 and Asthma control outcomes from baseline to week 12

Knopp Biosciences, AB Science & Synairgen achieve clinical milestones

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CI Scientists Remarks: 

  • This is a multi-center Phase 2 randomized, double-blind, placebo-controlled study to assess the effects of three dose levels of oral dexpramipexole for 12 weeks
  • Knopp Biosciences is targeting moderate-to-severe eosinophilic Asthma patient population for which injectable biologics are available in the market (Eg: Fasenra)
  • Knopp’s asset is the oral alternative. The top-line data for this trial is expected in early 2021

– Dr. Kowndinya, CI Scientists

For full story click here

AB Science presented Phase 3 results for Masitinib in severe Asthma at the annual European Respiratory Society International Congress

08 Sep 2020

Masitinib (Tyrosine kinase inhibitor) – AB Science

  • AB Science presented results from its Phase 3 trial AB07015 evaluating Masitinib in severe Asthma at ERS International Congress 2020
  • Abstract is selected for ALERT (Abstracts Leading to Evolution in Respiratory Medicine Trials) session
  • The abstract will be published in a supplemental edition of the European Respiratory Journal (September 2020)
  • Late breaking abstract – Masitinib in severe asthma: Results from a randomized, phase 3 trial
    Presenter: Prof. Dr. Pascal Chanez
    • Reduction in severe Asthma exacerbations: -35% (p=0.0103)
    • Reduction in rate of severe Asthma exacerbations (patients with high eosinophil counts, ≥ 150 cells/μL): -38% (p=0.0156)
    • Reduction in rate of severe Asthma exacerbations (patients with high eosinophil counts, ≥ 150 cells/μL receiving an annualized cumulative OCS intake of >1000 mg): -71%

CI Scientists Remarks: 

  • Masitinib is a first in class oral drug in severe Asthma, selectively targeting mast cells through inhibition of tyrosine kinases c-Kit, LYN and FYN
  • Unlike biologics, which typically show effect in patients with high eosinophil count of ≥ 300 cells/μL, Masitinib has demonstrated efficacy across patient population irrespective of baseline eosinophil count
  • AB0715 study was designed to recruit and treat all patients, irrespective of baseline eosinophil count, that are depended on OCS therapy
  • AB Science is trying to provide an alternate option for patients who are not eligible or have failed biologics

– Dr. Kowndinya, CI Scientists

For full story click here

Synairgen reported interim results of inhaled SNG001 in Phase 2 trial for COPD patients with a confirmed respiratory viral infection

08 Sep 2020

SNG001 (Interferon beta-1a) – Synairgen Plc

  • Synairgen announced the interim analysis data from its Phase 2 trial evaluating inhaled SNG001 in COPD patients with a confirmed respiratory viral infection
  • Results:
    • Antiviral activity:
      • Compared to the placebo group patients receiving SNG001 demonstrated enhanced antiviral responses to viral infection in lungs. It is assessed by measuring elevated gene expression of interferon beta-dependent antiviral biomarkers MX1 (p=<0.001) and OAS1 (p=<0.001) in lung (sputum) cells
    • Safety:
      • SNG001 well tolerated in this older population with a significant co-morbidity, as measured by FEV1: 59% of predicted value
      • AEs were similar in placebo (48.1%) and treatment groups (45.6%)
      • TRAEs: SNG001 group – 15.8% and placebo group – 25%

CI Scientists Remarks: 

  • Synairgen’s SNG001 in Phase 2 trial showed positive effect in patients with COPD
  • Synairgen has shifted its focus to COVID-19 and has paused its COPD program
  • With the data from this interim review of COPD trial, Synairgen is planning to initiate the development of SNG001 For COVID-19

– Dr. Kowndinya, CI Scientists

For full story click here

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