Although the asthma disease space is fairly mature, there is a continued need for more convenient and personalised medications. As shown by the chart below, asthma has a very robust research pipeline, with seven candidates across five drug classes, including products in both existing and novel drug classes for asthma therapy. There are also several double and triple combination inhalers in late-stage development for asthma that aim to improve compliance rates, which is currently a significant unmet need in asthma treatment.
Investigational products include AstraZeneca’s tezepelumab, which is an IgG2 mAb that binds to thymic stromal lymphopoietin (TSLP), and Chiesi’s oral CRTH2 antagonist timapiprant (CHF6532). The triple inhalers consist of combinations of inhaled corticosteroids (ICS), long-acting beta 2 agonists (LABA), and long-acting muscarinic antagonists (LAMAS) such as GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate + vilanterol), Chiesi’s Trimbow (beclometasone dipropionate + formoterol fumarate dihydrate + glycopyrronium) and Novartis’ QVM149 (glycopyrrolate + indacaterol maleate + mometasone furoate).
The Trelegy Ellipta is already available in the seven major markets (7MM – the US, France, Germany, Italy, Spain, the UK and Japan) for the treatment of chronic obstructive pulmonary disease (COPD). Trimbow received US approval for expanded use in September and European approval for asthma in February. The dual combination inhalers include Novartis’ ICS/LABA QMF149 (indacaterol + mometasone furoate) and AstraZeneca’s PT027 (budesonide +salbutamol). The latter will aim to replace salbutamol as the future of rescue therapy.
According to key opinion leaders (KOLs) interviewed by GlobalData, there is a large unmet need for the treatment of severe persistent asthma that is refractory to the standard therapies. The major obstacle to achieving successful treatment of severe asthmatics is the high level of heterogeneity of the disease. Severe asthma is not a single disease but rather consists of several clinical phenotypes, each with distinct underlying cellular pathologies.
Therefore, to address this difficult population of patients, there is a need for therapies that target subgroups of patients whose disease pathogenesis is mediated by a specific pathway. There are several monoclonal antibodies (Cinquair/Cinqaero, Fasenra and Dupixent) currently at the beginning of their lifecycles, and one (tezepelumab) in the late stages of clinical development. These therapies, however, are designated for a small subset of asthma patients.
In addition, poor patient adherence with existing therapies hinders the long-term goals of asthma symptom control and reducing the risk of exacerbation. GlobalData’s primary research indicated that adherence to this type of therapy can be as low as 20%. The reasons for non-adherence are numerous, including poor inhaler technique, poor perception, complex regimens and the cost of medication.
With the advent of triple therapy ICS/LAMA/LABA inhalers, this unmet need is expected to be partially met by the end of the forecast period. These therapies, however, are expected to only be available to moderate and severe persistent asthma patients, leaving intermittent and mild persistent asthma patients without better options than the current standards of care.