Abbott India Gets CDSCO Panel Nod To Conduct Phase III CT of Ursodeoxycholic Acid tablet

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Abbott India to conduct a phase-III clinical trial of Ursodeoxycholic Acid (UDCA) tablets 150 mg/300 mg/450 mg/600 mg.

This came after Abbott India presented the revised Phase-III clinical trial protocol along with a summary of changes before the committee.

Ursodeoxycholic acid is a bile acid used for the treatment of primary biliary cirrhosis (PBC). Ursodeoxycholic acid is a hydrophilic bile acid that mediates its biological effects via several mechanisms. Ursodeoxycholic acid (UDCA) protects hepatocytes and cholangiocytes from bile acid-induced damage, such as reactive oxygen species (ROS)-induced inflammation and mitochondrial dysfunction. UDCA was shown to reserve hepatocyte cell structures and stimulate anti-apoptotic pathways.It was also shown to prevent the production of ROS by Kupffer cells and resident macrophages in the liver, thus attenuating oxidative stress in the liver.

Last year, the expert panel at its 09th/24 meeting held on 12.09.2024 opined that the firm should revise the protocol with respect to the following points:

1. The firm shall define the normal ALT value for both males and females. The difference in ALT levels normalization has to be compared among the placebo arm and the test arm. And also, the ALT reduction value shall be defined as a percentage decrease from the baseline normal level.

2. Primary and secondary objectives shall be redefined to make the study a clinically meaningful outcome. The primary endpoint shall include fibroscan investigation at baseline and at six months of study duration, and the protocol shall also incorporate normalization of ALT value as an endpoint.

3. Sample size:

a. Shall be calculated based on single dose with respect to the placebo.

b. Shall be reworked based on the credible studies to strengthen the study objective.

In line with the above, at the recent SEC meeting for gastroenterology and Hepatology held on 12th December 2024, Abbott India presented the revised Phase-III clinical trial protocol along with a summary of changes before the committee

After detailed deliberation, the committee recommended conducting the Phase-III clinical trial as per the protocol presented by the firm.

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