Aurigene Oncology Ltd, a development stage biotechnology company and a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY), today reported results of INDUS-3, a Phase IIb double blind placebo-controlled study of AUR101 conducted in the United States, in patients with moderate to severe psoriasis.
The INDUS-3 study, listed at clinicaltrials.gov with identifier NCT04855721, met its primary endpoint of PASI-75 response at 12 weeks at the 400 mg BID dose, when compared to placebo. The primary endpoint of PASI-75 at 12 weeks at the 200 mg BID dose and the 400 mg QD dose were not met. There were no safety issues identified in the study. Aurigene will be closing the clinical development of AUR101 in psoriasis.
"The magnitude of efficacy improvement with AUR101 (versus placebo) in psoriasis are not what we hoped for in the study. While the positive statistical results at 400 mg BID confirm the role of RORγ in psoriasis, other agents, such as IL-17 antibodies as well TYK-2 inhibitors, lead to better results. In view of this, we believe that AUR101 will not add desirable benefit to patients with moderate to severe psoriasis. Therefore, we have decided to stop the clinical development of AUR101 as an oral drug in psoriasis. Pursuing AUR101 for other indications with suitable partners remains an option." said Murali Ramachandra, PhD, Chief Executive Officer of Aurigene.
Shares of Dr. Reddy's Laboratories Limited was last trading in BSE at Rs. 4471.30 as compared to the previous close of Rs. 4503.30. The total number of shares traded during the day was 4977 in over 928 trades.
The stock hit an intraday high of Rs. 4527.00 and intraday low of 4458.90. The net turnover during the day was Rs. 22286546.00.