CDSCO panel approves Sanofi's proposal to increase number of subjects from 25 to 40 in india to study SAR443122

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Sanofi in the Ulcerative Colitis Studies of SAR443122 to increase the number of subjects from India from 25 to 40 subjects with the condition that more government sites shall be included in the study and enrollment from government sites shall be increased.

This came after the firm presented the proposal to increase the number of subjects in the study from 25 to 40 subjects in India Protocol no. DRI16804.

This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe ulcerative colitis (UC). Dose selection for further clinical development will be based on the multiple efficacy, safety, and PK parameters.

The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per the investigator's assessment.

SAR443122 is a novel, potent, and selective RIPK1 inhibitor for oral administration. SAR443122 selectively inhibits the kinase function of RIPK1 and results in the inhibition of the production of pro-inflammatory cytokines and necroptotic cell death that are thought to be detrimental to the intestinal cell integrity. SAR443122 inhibits receptor-interacting serine/threonine-protein kinase 1 (RIPK1). It is currently being investigated against inflammatory diseases such as rheumatoid arthritis and psoriasis and against hyperinflammatory states in patients with severe COVID-19.

At the recent SEC meeting for gastroenterology and hematology held on 12th December 2024, the expert panel reviewed the proposal to increase the number of subjects in the study from 25 to 40 subjects in India (Protocol no. DRI16804).

After detailed deliberation, the committee recommended the approval to increase the number of subjects in the study from 25 to 40 in India as presented by the firm with the condition that more government sites shall be included in the study and enrollment from government sites shall be increased.

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