Sunday, February 23, 2020

Sunday, February 23, 2020

ONKURE, INC.: Announces FDA IND Regulatory Clearance to Start Phase 1 Trials for OKI-179


OnKure, Inc. issued the following announcement on May 6.

OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, announced that its lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start Phase 1 trials.

OnKure's platform is capable of transforming naturally occurring, biologically active lead compounds into commercial drugs that address a variety of diseases, with an emphasis on helping patients suffering from cancer. At the heart of OnKure's solution to Class 1 histone deacetylase inhibition, OKI-179 is a drug with a potency and selectivity profile that is reminiscent of Romidepsin, arguably the most potent Class 1 histone deacetylase inhibitor currently approved by the FDA. However, while Romidepsin is administered by continuous infusion, OKI-179 is delivered orally and has demonstrated an impressive safety profile in preclinical studies.

"We are delighted that OKI-179 is poised to enter clinical development," said Tony Piscopio, co-founder, President and Chief Executive Officer of OnKure. "We are excited to see how this potential best-in-class molecule will perform in carefully selected patient populations.”

Collaborating with OnKure on the clinical investigation of OKI-179 will be the University of Colorado, Anschutz Cancer Center, Aurora, CO and the University of Texas, Austin Dell Medical School.

“We are very excited to begin our first in human studies with OKI-179,” said S. Gail Eckhardt, M.D., FASCO, OnKure’s Chief Medical Officer and Professor at UT Austin. She added, “Our preclinical data suggests that OKI-179 may provide patients with a safer and more convenient alternative to Romidepsin, both as a stand-alone agent and in rational combinations with other targeted therapies.”

Original source can be found here.

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OnKure, Inc.

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