Teva has reported data from two phase III trials of reslizumab, its antibody therapy for moderate-to-severe asthma, setting up regulatory filings early next year.
The Israeli pharma company has joined a race with GlaxoSmithKline (GSK) and AstraZeneca (AZ) to bring an anti-interleukin-5 (IL-5) monoclonal antibody to market for asthma patients struggling to control symptoms.
While many patients with milder forms of asthma respond to drugs like corticosteroids and beta agonists, around 20 per cent find they cannot fully control symptoms with these medicines, and in some cases there is a pressing need for additional lines of therapy to prevent life-threatening breakthrough attacks.
In the two trials, reslizumab cut the number of asthma exacerbations in patients who have high levels of white cells called eosinophils in the blood – indicating the disease is not being controlled with current therapies – by 50% and 60% respectively.
Reslizumab also demonstrated a positive effect on lung function and asthma control in studies, which could help differentiate the drug in the marketplace, according to a company press release. Teva also noted that the drug’s side effect profile was comparable to placebo.
Clinicians will be able to cast their eye over the data when it is presented at the European Respiratory Society (ERS) congress, which starts on Saturday.
With filings scheduled for early 2015 in the US, Teva is a little behind GSK, which has indicated it plans to submit its anti-IL-5 candidate mepolizumab for approval around the end of the year, and a little ahead of AZ which started a phase III programme for its benralizumab drug last October.
The three IL-5 inhibitors – along with other new antibody-based therapies such as Regeneron/Sanofi’s IL-4 and IL-13 blocker dupilumab and AZ’s IL-13-targeting tralokinumab – are promising to usher in a new biologic era of asthma therapy that does not rely on inhaled therapies.
Novartis has sold an antibody therapy for allergic asthma called Xolair (omalizumab) – which works by blocking immunoglobulin E – since 2003. Despite a slow start in the market, Xolair has steadily gained traction and pulled in sales of more than $600m last year.
While new entrants are expected to expand the market by several billion dollars a year, the sheer number of new agents approaching the market is threatening to peg back their potential individually, unless one drug emerges with a clearly superior clinical profile.
Cost could also be a disincentive to their take-up given that currently asthma is managed predominantly with generic drugs, although the majority of costs to healthcare systems come from the management of patients with breakthrough attacks.