Advancements in Asthma Treatment: Next Steps and Insights From Clinical Development of Rilzabrutinib

Extensive safety data from thousands of patients across multiple indications should eventually support the education and confidence of physicians looking to prescribe rilzabrutinib for asthma, says Leda Mannent, MD, global project head, Immunology and Inflammation, Sanofi.

This transcript has been lightly edited.

Transcript

Can you provide insights into the next steps for clinical development, and the potential timeline for regulatory approval?

Of course, as you can see, we are very excited by these data, and we are working very hard with the team now to build the plans to move this new advanced therapy forward for a treatment option for patients with asthma. The team is currently working on these plans, and we will meet with the regulators. We will, of course, inform the community as soon as we launch these new phase 3 studies in asthma with rilzabrutinib.

How is rilzabrutinib's tolerability profile being evaluated, considering the burden of adhering to twice-daily dosing for patients with a chronic condition like asthma?

These are patients that have a chronic disease; they are often used to getting inhaled corticosteroids twice a day. In our clinical studies, we evaluated the compliance, and there was actually a very high compliance/adherence to the therapy given as a twice-daily regimen. In addition, I would like to mention that currently, a patient has to deal also with injectables. So, having an additional advanced oral therapy will really add to the current therapies and to the current standard of care a new treatment for patients with asthma.

Some physicians might be hesitant to prescribe a medication from a new class of drugs, like Bruton tyrosine kinase (BTK) inhibitors for asthma. How can these concerns be addressed to educate them about the potential benefits and safety profile of rilzabrutinib?

Of course, as for any new therapy out there, there are questions, and the education comes with evidence, so we will bring this evidence in multiple patients and long-term safety. I would like to point out that currently, there are more than 1000 patients that have been treated with rilzabrutinib across multiple indications, so we have a substantial amount of safety data, including patients that have been treated up to 2 or 3 years. As we are moving on with large clinical studies we will provide this evidence also, more specifically in patients with asthma in order to weigh this benefit-risk in this population for long-term treatment. So there will be data of 1 year or more safety data at the time this drug hopefully will be an option for the prescribers.