Cadila Healthcare rose 1.20% to Rs 468.20 after the US-based drug regulator, United States Food and Drug Administration (USFDA) approved the initiation of EPICS-III Phase 2(b)/3 clinical trial in patients with Primary Biliary Cholangitis (PBC).
The EPICS-III trial will randomise 192 subjects in a 1:1:1 ratio to Saroglitazar 1 mg, Saroglitazar 2 mg or placebo and study the Saroglitazar Magnesium (1 or 2 mg) relative to placebo based on the composite endpoints of Alkaline Phosphatase (ALP), total bilirubin, liver stiffness measurement (LSM) by FibroScan, liver enzyme parameters (ALT, AST, GGT, total bilirubin, and albumin), lipid parameters (TG, LDL-C, HDL-C, VLDL-C, total cholesterol, and non-HDL-C), health related quality of life using PBC 40 questionnaire (a patient-derived, disease specific quality of life measure developed and validated for use in PBC) and other outcome measures over a period of 52 weeks.
The change in Pruritus (60- 70 % of patients with PBC liver disease develop systemic itch of the skin that significantly impairs activity and sleep) will be studied using 5-Domains (5-D) itch scale, patient global impression of change scale, patient global therapeutic benefit scale and patient global impression of worst itch severity scale.
The company's consolidated net profit surged 608.10% to Rs 2,999.60 crore on 2.4% increase in net sales to Rs 3,687 crore in Q2 September 2021 over Q2 September 2020.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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