Remarkable results for novel biologic therapy for asthma

A novel biologic therapy targeting both TSLP and IL-13 swiftly and substantially reduced fractional exhaled nitric oxide (FeNO) in patients with asthma, suggesting that this agent, provisionally named SAR443765, inhibits airway inflammation and protects airway function in this group of patients. 

“NANOBODY molecules are a type of miniature, engineered antibodies, derived from Camelid heavy-chain only monoclonal antibodies,” outlined Dr Benjamin Suratt (Sanofi, NJ, USA). “SAR443765 is the first NANOBODY molecule in development for asthma.” The drug candidate is a bi-specific monoclonal antibody which acts by targeting IL-13 and TSLP. To test this experimental biologic agent, Dr Suratt and co-investigators designed a double-blinded, placebo-controlled phase 1 trial in which 36 patients with mild-to-moderate asthma were randomised 2:1 to a single dose of SAR443765 or to placebo [1]. Safety and change from baseline FeNO at day 29 were the main outcomes of the study. 

Compared with placebo, a single dose of SAR443765 resulted in a significant reduction in FeNO at day 29 (mean +0.8 ppb vs -39.1 ppb; P<0.1). At day 8, the reduction in FeNO in patients that received SAR443765 was already substantial (mean -33.0 ppb). Dr Suratt expressed that this reduction in FeNO appears to be much larger than the FeNO reductions that were reported in trials investigating TSLP inhibitors or IL-13 inhibitors. Furthermore, numerical improvements in lung function were observed for patients receiving SAR443765, despite the fact that these patients had close-to-normal lung functions at baseline. Finally, no serious adverse events were reported and the overall treatment-emergent adverse event rates were 75% in both arms of the study. 

1. Suratt B, et al. Targeting of TSLP and IL-13 by the novel NANOBODY molecule SAR443765 reduces FeNO in asthma following single-dose exposure. B13, ATS International Conference 2023, 19–24 May, Washington DC, USA. 

 

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Posted on 12 June, 202313 June, 2023