CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to Study JNJ-77242113

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Johnson and Johnson's protocol amendment proposal for the drug JNJ-77242113.

This came after the firm presented Protocol Amendment 3 dated 02 April 2024 protocol no. 7242113UCO2001.

JNJ-77242113 or JNJ-2113 stands out as the first oral peptide specifically designed to inhibit the IL-23 receptor. This means it blocks the activity of the IL-23 receptor, which is a protein involved in the immune system's inflammatory processes. Interleukin-23 plays a significant role in the development and progression of plaque psoriasis, a chronic skin condition characterized by red, itchy, and scaly patches. By inhibiting the IL-23 receptor, JNJ-2113 can potentially reduce the inflammation, proliferation, and development of psoriatic plaques, thereby alleviating symptoms associated with moderate-to-severe plaque psoriasis.

The mechanism of action of JNJ-2113, a targeted oral peptide, involves specifically blocking the activity of the interleukin-23 (IL-23) receptor, which plays a critical role in the immune system's inflammatory processes.

At the recent SEC meeting for gastroenterology and hepatology held on June 20, 2024, the expert panel reviewed Protocol Amendment 3 dated 02 April 2024 protocol no. 7242113UCO2001.

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

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