Aurigene Oncology Limited, a wholly owned subsidiary of Dr Reddy’s Laboratories, on December 16 announced that it will stop the clinical development of AUR-101, an oral drug for moderate to severe psoriasis, in the US.
The molecule was under clinical trial phase 2. The decision to stop the trial was announced in an exchange filing by Dr Reddy’s after Aurigene reported results of the Phase 2 trials of AUR 101.
“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,” Aurigene Oncology said.
Murali Ramachandra, Chief Executive Officer of Aurigene, said the magnitude of efficacy improvement with AUR101 (versus placebo) in psoriasis was less than expected.
“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 benefits 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 Ramachandra.
The shares of Dr Reddy's Lab declined 2.53 percent in afternoon trade on Friday on the National Stock Exchange to Rs 4,356.05, as against Rs 4,468 at the close on the previous day.
The company said AUR-101 has been found to be safe in preclinical toxicology evaluations, at several fold of efficacious exposures in humans and has also shown good pharmacodynamic modulation in earlier clinical trials.
In February 2020, Aurigene had announced that the first patient was dosed with AUR101 in Phase 2 study in patients with moderate to severe psoriasis.
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