Cudetaxestat Well-tolerated in Esbriet, Ofev Combos in Phase 1 Trial
Cudetaxestat (BLD-0409), an experimental medication for idiopathic pulmonary fibrosis (IPF) from Blade Therapeutics, was well-tolerated among healthy volunteers when given in combination with other IPF treatments — specifically nintedanib and pirfenidone — in a Phase 1 study.
“These findings provide confidence in the potential to safely co-administer cudetaxestat on top of the currently approved therapies in patients with uncontrolled IPF,” Wendye Robbins, MD, president and CEO of Blade, said in a press release.
Blade is planning to submit a package of Phase 1 trial data soon to the U.S. Food and Drug Administration (FDA), ahead of planned discussions with regulators about the future development of cudetaxestat.
“We look forward to discussing these data with regulatory authorities as we proceed toward the next phase of clinical development for cudetaxestat,” Robbins said.
The biopharmaceutical company also is planning to launch a Phase 2 trial testing cudetaxestat in people with IPF in the second quarter of this year.
Cudetaxestat is designed to block the activity of an enzyme called autotaxin, which produces a signaling molecule that promotes fibrosis, or tissue scarring. The medication has been well-tolerated in prior Phase 1 trials that assessed its safety and pharmacological properties in healthy volunteers.
Blade launched a Phase 1 trial late last year to test cudetaxestat in combination with either Ofev (nintedanib) or Esbriet (pirfenidone) — two FDA-approved oral treatments for IPF. Preclinical research conducted in rats suggested that cudetaxestat does not interact with Ofev.
The Phase 1 trial (NCT04939467) enrolled 83 healthy adults, ages 18 to 55. Participants were given cudetaxestat (750 mg/day) in an oral tablet, in addition to either Ofev (150 mg twice daily; given by oral capsule) or Esbriet (267 mg three times daily, also given by oral tablet).
The results showed that both treatment combinations were well-tolerated, with no serious adverse events reported, and no study participants discontinuing the study due to such side effects.
“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,” said Toby Maher, MD, PhD, a professor of medicine at the University of Southern California.
“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,” Maher said.
Blade said it expects to submit its data package on the drug-drug interaction trial to the FDA in the first quarter of the year.