Aurigene reports results of AUR101 in phase II study in US patients

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients

Aurigene Oncology, a development stage biotechnology company, has 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, 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 is 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, Chief Executive Officer, Aurigene.

AUR101 is a potent, oral RORΥt inverse agonist, with high selectivity across other ROR isoforms and nuclear hormone receptors and expected to confer a superior safety profile. AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients and also very significant reduction in ear swelling and histopathology scores in two separate pre-clinical psoriasis models. In addition, AUR101 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.