IQVIA gets CDSCO panel Nod To Study ABX464
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New Delhi: The leading global contract research organization, IQVIA has got the green signal from the Subject Expert Committee(SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase-III clinical trial of ABX464 belonging to the class of organic compounds known as aminoquinolines and derivatives.
This came after the firm presented Phase-III clinical trial protocol number- ABX464-106, Version -3.0, dated Oct. 06, 2022, before the committee.
ABX464 is a first-in-class, clinical-stage, small molecule for oral administration that has shown strong anti-inflammatory effects in the DSS-model for inflammatory bowel disease (IBD) and also prevents replication of the HIV virus.
ABX464 interacts with the cap-binding complex, allowing specific splicing of anti-inflammatory miR-124 (microRNA-124), leading to a cascade of dextran sulfate sodium modulating proinflammatory cytokines.
At the recent SEC meeting Gastroenterology & Hepatology held on 18th April 2023, the expert panel reviewed the Phase III clinical protocol number- ABX464-106, Version -3.0, dated Oct. 06, 2022,
After detailed deliberation, the committee recommended the grant of permission to conduct the study.
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