First carbon minimal pMDI is on track with the joint goal of benefitting patients and the planet

In 2019, Chiesi committed €350m to develop the first carbon minimal pressurised metered dose inhaler (pMDI) to treat asthma and Chronic Obstructive Pulmonary Disease (COPD) by 2025, replacing the current hydrofluorocarbon propellant with a new propellant.

Due to the low global warming potential of the new device, Chiesi will reduce its scope 3 or indirect greenhouse gas emissions – including the use of its pMDI products – by 90% in 2035.

In May this year, two phase 1 trials were duly completed and the new formulation provided evidence of similar lung deposition, systemic exposure, safety and tolerability when compared to the current one. These studies achieved their goal in confirming that the development of the new product (HFA-152a) is suitable to continue the planned clinical-regulatory pathway.

Chiesi entered into a commercial agreement with Koura Global, the leading medical propellant manufacturer, to supply HFA-152a for inhalation product development, clinical trials and eventually for market placement.

Koura is also progressing in its programme to demonstrate that the new HFA-152a propellant is safe for human use, a critical element in choosing a next generation propellant for MDIs. The few remaining aspects of the programme and the final reports will be completed later this year.

Meanwhile, results are reassuring so far, including a clinical trial involving healthy volunteers, which raised no concerns regarding taste, odour or acceptability, and no adverse effects were reported.

Chiesi is committed to maintaining access to the range of treatment options that asthma and COPD patients need globally. As a certified B Corp, the company innovates to find safe and environmentally conscious solutions and shares the ambition of the European Commission (EC) to reduce the carbon emissions linked to F-gases on the EU’s road to climate neutrality by 2050.

Alessandro Chiesi, chief commercial officer at Chiesi, explained: “With these results, we have reached a very important milestone in our Carbon Minimal Inhalers programme and on the road to fulfil our climate commitments on scope 1, 2 and 3 emissions by 2035.

“This is a key step forward in our plan, we are fully on track and really reassured that our work to date has been successful. We will continue prioritising #ActionOverWords in the fight against climate change and in ensuring that this never compromises the quality of care we provide our patients.”

Earlier this year, the EC published its proposal to review the 2014 fluorinated greenhouse gas (F-gas) regulation, which includes a gradual phase down of climate-damaging F-gases in the EU. Previously medical uses of F-gases, such as pMDIs, were exempt from this phase down, but the new proposal plans to remove this exemption.

While in full support of the F-gas phase down strategy, Chiesi calls on the EC to ensure that this does not compromise patient care and choice by considering the unpredictability of pharmaceutical development and the uncertainties of the regulatory approval process for medical products.