A Study of SelK2 in Subjects with Asthma (Part 1) and COPD (Part 2)
Research type
Research Study
Full title
A Two Part, Randomised, Double-blind, Placebo-controlled, Phase 2 Parallel Group Study to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 on Airway Responses Following Allergen Challenge in Subjects with Asthma (Part 1) and to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 in Subjects with Chronic Obstructive Pulmonary Disease (Part 2)
IRAS ID
281631
Contact name
Jonathan Stocker
Contact email
Sponsor organisation
Tetherex Pharmaceuticals Corporation
Eudract number
2020-001027-13
Duration of Study in the UK
0 years, 6 months, 8 days
Research summary
Research Summary
This study is being conducted for research purposes. The study drug ‘SelK2‘ is an anti-inflammatory (reduces swelling) and is being investigated as a potential treatment for asthma and Chronic obstructive pulmonary disease (COPD).Both asthma and COPD are lung diseases associated with inflammation of the airways which cause symptoms such as wheezing, shortness of breath and in people with COPD, phlegm production. It is hoped that SelK2 will reduce inflammation in the lungs and therefore lessen these sympoms.
The purpose of this study is to look at how safe and effective SelK2 is in people with mild asthma and COPD.
Part 1 of the study will measure lung function response (change in breathing) to allergen tests which involves breathing in a mist of an allergen that the person is sensitive to. The allergen test will help to measure the effect of the study drug in asthmatics.
Part 2 will assess changes in lung function before and after intake of the study drug.
Phlegm and blood samples will be analysed in both study parts to look for changes in inflammatory cells. Blood samples will also be tested to see how the body absorbs and breaks down SelK2, known as Pharmacokinetic analysis, and to look at certain biological features of these samples. This can be used to measure the presence or progress of disease or the effects of a treatment.
The study will compare the effects of SelK2 to a placebo (a dummy drug with no active ingredient) as a control, which allows us to evaluate the true effect of the experimental drug.
The study drug will be administered intravenously (via a drip into a vein) twice in Part 1 and once in Part 2.
Summary of Results
In Part 1, a total of 36 asthmatic participants were enrolled, of which 18 participants received the study drug SelK2 and 18 participants received placebo (‘dummy’ drug with no active ingredients).A double dose of SelK2 three weeks apart was shown to be safe and well tolerated in stable allergic asthma participants.
The results indicated that following the allergen challenge procedure eosinophils (a type of white blood cell) were markedly reduced in the lungs of participants treated with SelK2 in comparison with those participants who received placebo. This suggests that the improvement in lung function seen in participants receiving SelK2 was due to a reduction in eosinophils.
These data provide a strong justification for the continued development of SelK2 for the treatment of asthma.
In Part 2, a total of 25 Chronic Obstructive Pulmonary Disease (COPD) participants were enrolled, of which 17 participants received SelK2 and 8 participants received placebo.
A single dose of SelK2 was safe and well-tolerated in subjects with COPD.
The Part 2 results indicated statistically significant reductions in the numbers of some types of white blood cells (neutrophils, eosinophils), epithelial cells (cells which line the lungs), and the total number of cells collected per gram of sputum (phlegm) seen in participants treated with SelK2 compared to placebo at multiple time points.
Studies have shown that the increase in the number of sputum epithelial cells is a marker of damage to the airway epithelial cell lining in the lungs. Therefore, seeing a reduction in these cell types after a single dose of SelK2 is encouraging. Whether reductions in these inflammatory cells in COPD will translate into improvements in lung function and participant reported outcomes will be addressed in future studies.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0251
Date of REC Opinion
29 Jun 2020
REC opinion
Further Information Favourable Opinion