Sanofi has announced positive outcomes from a Phase II clinical trial of rilzabrutinib, an oral treatment for adults with uncontrolled moderate-to-severe asthma.

The double-blind, randomised, placebo-controlled, parallel-group trial analysed the safety, tolerability and efficacy of rilzabrutinib over 12 weeks.

Participants in the trial were adults with asthma not adequately controlled by standard inhaled corticosteroid (ICS) and long-acting β2 adrenergic agonist (LABA) treatment.

Two dosing regimens of rilzabrutinib – 800mg and 1,200mg daily – were evaluated against a placebo, with all patients continuing their ICS/LABA treatment, which was phased out during the study.

The reduction in loss of asthma control (LOAC) events was the trial’s primary endpoint.

Asthma control, quality of life and lung function were the secondary endpoints.

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The study revealed that both the high and low doses of rilzabrutinib led to a numerical decrease in LOAC events, meeting the primary endpoint, along with symptomatic improvements.

At week 12, the high dose showed a 36% relative risk reduction in LOAC events, while the low dose exhibited a 25% reduction.

Additionally, both doses achieved nominally significant and clinically meaningful enhancements in ACQ-5 scores, with improvements noted as early as week two.

Rilzabrutinib was found to be well tolerated throughout the 12-week treatment period without any cases of cytopenia, haemorrhagic events, atrial fibrillation, or liver function test imbalances reported.

Diarrhoea was observed to be the most common treatment-emergent adverse event (TEAE), with a higher incidence in the rilzabrutinib group versus placebo.

These findings will inform the upcoming Phase III programme, which will explore a twice-daily dosing schedule of rilzabrutinib for the treatment of moderate-to-severe asthma.

Sanofi Research and Development head and executive vice-president Houman Ashrafian said: “We are incredibly encouraged by the reduction in loss of asthma control events and improvements in asthma symptoms and look forward to advancing rilzabrutinib into a broader Phase III clinical development programme to further explore its potential in this disease.

“Advanced oral therapies have the potential to change the treatment paradigm for diseases like asthma, and we remain committed to exploring disruptive mechanisms of action for people living with uncontrolled chronic inflammatory diseases.”

Last month, Sanofi advanced its natural killer (NK) cell engager candidate SAR443579/IPH6101 to a Phase II trial in treating a range of blood cancers.