CDSCO Panel Approves Sanofi's Protocol Amendment Proposal For Study of SAR443122 in Ulcerative Colitis

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Sanofi's proposal for amendment of the clinical trial protocol titled, 'Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis (RESOLUTE).

This came after the firm presented protocol amendment 05, version 1 dated 25 September 2023 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. 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.

At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks of induction treatment will roll over to an open-label treatment arm and will be treated with SAR443122 at the highest tested dose.

In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.

SAR443122 is a novel, potent, and selective RIPK1 inhibitor for oral administration. SAR443122 selectively inhibits the kinase function of RIPK1 and inhibits the production of pro-inflammatory cytokines and necroptotic cell death that are thought to be detrimental to intestinal cell integrity.

SAR443820 works by suppressing an enzyme known as RIPK1 (receptor-interacting protein kinase ). The over-activation of this enzyme is associated with abnormal microglia activity and nerve cell death. Microglia are immune cells involved in the central nervous system, brain, and spinal cord.

At the recent SEC meeting for Gastroenterology and Hepatology held on 15th February 2024, the expert panel reviewed the proposal presented by the drug major Sanofi for protocol amendment 05, version 1 dated 25 September 2023 protocol No. DRI16804.

After detailed deliberation, the committee recommended approval of the protocol amendment presented by the firm.

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