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Current indications
ME-015 Mode of Action
Firstly, ME-015 is presumed to have an acute effect by stabilising ion channels in the neuronal endings in the lungs that mediate cough.
Secondly, ME-015 is presumed to sub-acutely reduce neuronal inflammation and hyperactivity by acting as a reactive oxygen species scavenger thus reducing the hypersensitisation of neuronal receptors to otherwise innocuous stimuli.
This is further supported by ME-015's well-established chronic anti-inflammatory effect on key cells of the raised immune reaction in IPF.
Two-minute explainer video
Benefits of ME-015 in IPF cough
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ME-015 is an oral and safe molecule benefiting from more than 25 years of real-world safety data.
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Its safe profile is an advantage for use in frail IPF patients and utilisation of ME-015 will not necessitate monitoring/physician visits.
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ME-015 has no drug-drug interaction which is beneficial in IPF cough patients that often are subject to polypharmacy.
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Impact on the cough will improve the QoL in IPF patients that, unfortunately, with current medications still have a limited life expectancy upon diagnosis
Phase 2 PoC study
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A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the efficacy and safety of Suplatast Tosilate for treatment of cough related to Idiopathic Pulmonary Fibrosis (IPF)
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The study will enrol 40 patients for a 6-week study (2 weeks Active/PLB, 2 weeks wash out followed by cross over and a new 2-week period (PLB/Active).
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The study is planned to report topline data by beginning 2025.
Exploratory Data
High likelihood of efficacy demonstration in planned phase 2a clinical proof of concept study
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The molecule has already demonstrated efficacy in cough in 4 exploratory clinical trials in different therapeutic areas with cough.
Atopic cough
Atopic cough, 10 patients, randomised cross over, single blind study vs placebo, 4 weeks treatment with ME-015 significantly increased cough threshold compared to the value obtained with placebo
References
1. Zhu et al. Increased expression of TRPV1 in patients with acute or chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr; 10(4): 988–991.
Cough in atopic asthma
Cough in atopic asthma, 22 patients, randomised cross over study vs placebo, 2 weeks treatment with ME-015 improves cough reflex significantly vs placebo
Cough after lung cancer surgery
Cough after lung cancer surgery. 19 patients suffering from chronic cough for an average of 400 days, open label study. After 1 month of treatment, 16 patients were rated as improved, 3 patients were unchanged, and no patient was worse than before. Evaluation based on physician classifying together with the patient the patient’s disease state (improved, unchanged, worse).
Cough variant asthma
Cough variant asthma, 20 patients, 6 weeks randomised cross over study vs placebo. The patients evaluated their coughing four times a day, every 6 h, and recorded the cough points in a diary. The evaluations were ‘‘quite often’’ (21 times or more) – four points, ‘‘often’’ (11–20 times) – three points, ‘‘relatively often’’ – (six–ten times) – two points, ‘‘not often’’ (five times or fewer) – one point, and ‘‘none’’ – zero points. The total cough points in a day became the cough score.
The progressive improvement of cough scores was significant in the suplatast group (Fig. 1). In the suplatast group, the cough scores were decreased significantly (24.5±6.1 at week 1, 19.8±5.5 at week 2, 17.1±6.2 at week 3, 16.3±5.8 at week 4, 15.6±6.5 at week 5, 14.4±5.5 at week 6) in comparison with the value of 33.4±4.8 at week –2 (run in period), whereas in the placebo group there was no significant difference in change from the baseline.
Pipeline
Additional indications
Melius Pharma is currently in early stage of evaluating ME-015 for other indications in therapeutic areas with high unmet clinical need