SOUTH SAN FRANCISCO, Calif.– Blade Therapeutics, Inc. (“Blade”), a biopharmaceutical company focused on developing cutting-edge treatments for debilitating fibrotic and neurodegenerative diseases, today announced the successful completion of a phase 1 drug-drug interaction clinical study of cudetaxestat, an investigational non-competitive autotaxin inhibitor in clinical development for IPF and other fibrotic diseases.
The phase 1 study assessed the effect of cudetaxestat 750mg on the pharmacokinetics of two approved drugs for IPF – pirfenidone and nintedanib – in 83 healthy adult volunteers (NCT04939467). In the study, co-administration of cudetaxestat with either pirfenidone or nintedanib showed that cudetaxestat was well tolerated, with no reports of drug-related serious adverse events or discontinuations due to treatment-emergent adverse events.
Toby Maher, M.D., Ph.D., professor of medicine at USC Hastings Center for Pulmonary Research, Los Angeles, said, “Existing treatments slow, but do not prevent, progression of fibrosis and the development of respiratory failure. There is a huge unmet need for new antifibrotic therapies which can complement current treatments and provide greater benefit for patients. This phase 1 study of cudetaxestat provides a clear path to proceed into a phase 2 study that addresses this need for novel therapeutics that may be administered together with current anti-fibrotic drugs.”
Wendye Robbins, M.D., president and CEO of Blade, said, “These findings provide confidence in the potential to safely co-administer cudetaxestat on top of the currently approved therapies in patients with uncontrolled IPF. We look forward to discussing these data with regulatory authorities as we proceed toward the next phase of clinical development for cudetaxestat.”
Blade expects to submit an end-of-phase 1 data package to the FDA in the first quarter of 2022 prior to planned discussions with regulatory authorities to further inform the clinical development program for cudetaxestat. The company plans to start a phase 2 clinical study of cudetaxestat in patients with IPF in the second quarter of 2022.
