Sanofi Healthcare Gets CDSCO Panel Nod to Study Asthma Drug SAR443765
New Delhi: The drug major Sanofi Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSCO to conduct the trial of the pulmonary drug SAR443765 (lunsekimig) solution for injection 165 mg/1.1 mL (150 mg/mL).
This came after the firm presented phase 2 clinical trial protocol no. LTS17231 Version No. 1 Protocol Date 07-JUN-2024. This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with moderate-to-severe asthma who have previously completed the parent study. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with Lunsekimig.
SAR443765 is a novel anti-thymic stromal lymphopoietin (TSLP)/anti-IL-13 engineered antibody (nanobody molecule) shown to significantly and rapidly reduce FeNO in patients with mild-to-moderate asthma after one dose. Combined TSLP/IL-13 blockade is expected to improve lung function, particularly small airway dysfunction, which has been shown to correlate with poor disease control and type 2 inflammation.
Lunsekimig is a monoclonal antibody commercialized by Sanofi, with a leading Phase II program in Asthma.
At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed the Phase 2 clinical trial protocol no. LTS17231 Version No. 1 Protocol Date 07-JUN-2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the phase 2 clinical trial as presented by the firm.
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