Sanofi Healthcare has been granted permission by the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) in India to proceed with a Phase 2 clinical trial of SAR443765 (lunsekimig) solution for injection (165 mg/1.1 mL, 150 mg/mL) for the treatment of asthma. This decision follows a review of the Phase 2 clinical trial protocol no. LTS17231 Version No. 1, dated June 7, 2024.
The trial is designed as a Phase 2, open-label extension study to assess the long-term safety and efficacy of lunsekimig in adult participants with moderate-to-severe asthma who have previously completed the parent study. Eligible participants from the parent study will be offered the opportunity to enroll in this long-term extension (LTE) study.
Mechanism of Action
SAR443765, also known as lunsekimig, is a novel anti-thymic stromal lymphopoietin (TSLP)/anti-IL-13 engineered antibody, formulated as a nanobody molecule. Preclinical and early clinical data suggest that it can significantly and rapidly reduce fractional exhaled nitric oxide (FeNO) levels in patients with mild-to-moderate asthma after a single dose. The combined blockade of TSLP and IL-13 is hypothesized to improve lung function, particularly in cases of small airway dysfunction, which has been correlated with poor disease control and type 2 inflammation.
Lunsekimig is currently under development by Sanofi, with this Phase 2 program in asthma representing a key stage in its clinical development.
SEC Review and Recommendation
During the recent SEC meeting for pulmonary drugs held on October 3, 2024, the expert panel thoroughly reviewed the Phase 2 clinical trial protocol. Following detailed deliberation, the committee recommended granting permission to Sanofi Healthcare to conduct the Phase 2 clinical trial as presented.
