OnKure Announces FDA IND Regulatory Clearance
to Start Phase 1 Trials for OKI-179
NEWS PROVIDED BY
May 6, 2019 9:00 ET
BOULDER, Colo., May 6, 2019 /BusinessWire/ — 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.”
OnKure, Inc. is a biopharmaceutical company focused on the discovery and development of targeted small molecule drugs to improve the outcomes of patients afflicted with cancer. OnKure’s drug candidates aim to treat patients by targeting malignant cells directly, by working in combination with other small molecule therapies and by priming the tumor microenvironment such that checkpoint inhibition is optimized. For more information about OnKure and OKI-179, please visit www.onkuretherapeutics.com.