Aurigene announces first patient dosed with AUR101 in phase ii study in patients with moderate to severe psoriasis

The initiation of this Phase II study under a US FDA IND represents a significant milestone for Aurigene, as it marks the first programme which Aurigene has led from the bench side to the clinic all by itself

Psoriasis, Aurigene, AUR101, US FDA IND, Chief Executive Officer, Murali Ramachandra, Three-arm study, Clinic

Aurigene, a development stage biotechnology company, announced dose administration for the first patient in INDUS-2, a Phase II double blind placebo-controlled three-arm study of AUR101 in patients with moderate to severe psoriasis. AUR101 is an oral small molecule inverse agonist of RORγ and has shown desirable pharmacodynamic modulation of IL-17 and acceptable safety in a completed Phase I human study conducted in Australia. 

"The initiation of this Phase II study under a US FDA IND represents a significant milestone for Aurigene, as it marks the first programme which Aurigene has led from the bench side to the clinic all by itself," said Murali Ramachandra, PhD, Chief Executive Officer of Aurigene. "We look forward to producing important clinical data by the end of 2020 to guide our future development plans and demonstrating Aurigene’s unique expertise in conducting Proof-of-Concept studies in a quality and fast-paced manner."

The purpose of the Phase II multi-center, blinded, placebo-controlled, three-arm study is to evaluate the clinical activity of AUR101 in patients with moderate to severe psoriasis. In two of the arms, AUR101 will be administered twice daily, at 400 mg PO BID and 600 mg PO BID, for 12 weeks. Patients in the third arm will receive matched blinded placebo in a double dummy fashion. The trial is listed at clinicaltrials.gov with identifier NCT04207801.

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