Sanofi's Lunsekimig (SAR443765) Receives CDSCO Panel Nod for Phase 2 Asthma Trial
Key Insights
Sanofi Healthcare (search) has received approval from the CDSCO panel in India to conduct a Phase 2 clinical trial for SAR443765 (lunsekimig) in asthma (search) patients.
The trial is an open-label extension study evaluating the long-term safety and efficacy of lunsekimig in adults with moderate-to-severe asthma (search).
Lunsekimig is a novel anti-TSLP (search)/anti-IL-13 (search) nanobody molecule that has shown promise in reducing FeNO levels in asthma (search) patients.
Sanofi Healthcare (search) 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 (search). 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 (search) 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 (search))/anti-IL-13 (search) 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 (search) 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 (search) 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 (search) to conduct the Phase 2 clinical trial as presented.