Chiesi backs up COPD triple therapy with real world study

Chiesi is hoping real world evidence will show its latest COPD triple therapy can help cut hospital admissions for the disease.

Trimbow (beclometasone+formoterol+glycopyrronium) combines an inhaled corticosteroid (ICS), a long-acting beta adrenoceptor agonist (LABA) and a long-acting muscarinic antagonist (LAMA) in a single delivery device, in an extra-fine formulation.

The drug is likely to be the first COPD triple therapy on the market, after Europe’s CHMP committee recommended a marketing authorisation late last month.

But while it waits for the European Commission to grant a licence, Chiesi is already planning ways to differentiate itself from rivals.

GlaxoSmithKline’s rival triple therapy is under review in Europe, while AstraZeneca also has a triple therapy in the pipeline.

The market for COPD drugs is also crowded with older drugs, and Chiesi hopes that an additional “real world” study, perhaps showing reductions in costly hospital visits due to COPD exacerbations, could convince National Health Service prescribers to switch their patients over.

Many patients still use triple therapies by combining various drugs already on the market, and although Chiesi is not giving anything away about its pricing plans, the company hopes the drug will prove to be a more convenient alternative.

The family-owned company is also not providing sales forecasts, but GSK’s rival is predicted to break through the billion-dollars a year barrier.

Chiesi’s drug is seen by some as a major competitor to GSK in a triple COPD therapy market, expected to be worth more than $3 billion a year by 2018.

Even though the drug’s label will dictate that the drug is only used in very sick patients who cannot control their symptoms, this still accounts for a sizeable proportion of the patient population.

Advanced discussions over real world study

Around 40% of the treated population already use various combinations of different products to get a triple therapy – around 400,000 patients in the UK.

Dr Cham Herath, medical director at Chiesi, said: “We are in advanced discussions with likely external stakeholders and opinion leaders that might be interested in trying to demonstrate the benefits of Trimbow in a real-world COPD population.”

GSK has already attempted something similar with its Salford Lung Study – a real world phase 3 trial involving its new drug Relvar Ellipta.

The Salford study produced positive top-line results but did not demonstrate that the drug cuts visits to hospital and primary care, which are expensive for the NHS as well as an indication that patients are not controlling their disease.

But Chiesi is convinced that taking this approach will produce compelling data, as the reduction in hospital admissions was marked in patients with moderate to severe disease.

Conventional clinical studies have already demonstrated a decrease in exacerbations in patients treated with Trimbow, Herath noted.

Chiesi's Cham Herath

Herath added: “The real word study is to prove that these significant reductions in exacerbations and symptom control seen with Trimbow in the phase 3 studies are replicable in the at the frontline of COPD care. We have no reason to believe that that they are not replicable.”

Chiesi also plans a trial to test whether its extra fine formulation is better at penetrating the lung compared with an existing therapy.

The trial will compare the triple therapy with a conventionally formulated rival to see whether it reduces incidence of trapped air in the lungs.

Herath said: “I think there are a lot of drug options out there bit we still have unmet needs. It is about gathering more data about what is the best option and how to treat these patients.”