Phase 1 Trial of Cudetaxestat as IPF Combo in Healthy Adults Opens

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by Patricia Inacio PhD |

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A Phase 1 trial assessing how cudetaxestat, an investigational treatment for idiopathic pulmonary fibrosis (IPF), interacts with two approved IPF treatments, Ofev (nintedanib) and Esbriet (pirfenidone), is now enrolling healthy volunteers, Blade Therapeutics, the therapy’s developer, announced.

The trial (NCT04939467) is aiming to enroll 86 healthy adults, ages 18 to 55. Following an overnight fast, participants will receive the oral combination therapies in a fixed sequence: either 150 mg of Boehringer Ingelheim’s Ofev twice daily or 267 mg of Genentech’s Esbriet three times daily, and a daily dose of cudetaxestat at 750 mg.

Study sites in the U.S. are not yet listed, but those interested can find contact information here.

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FDA OKs Clinical Trial Testing Cudetaxestat With Ofev, Esbriet

The trial’s main goal is to determine how cudetaxestat affects the pharmacokinetic profile of Ofev and Esbriet. Pharmacokinetics refers to the movement of a medicine into, through, and out of the body.

Expected to conclude by March 2022, Phase 1 results will help to inform a Phase 2 trial, which is expected to launch by June, evaluating the efficacy and safety of cudetaxestat in IPF patients.

“Blade continues to make progress advancing the clinical development program for cudetaxestat,” Wendye Robbins, MD, Blade’s president and CEO, said in a press release.

Cudetaxestat works by blocking the activity of autotaxin, an enzyme that makes a pro-scarring (fibrotic) signaling molecule and is commonly overactive in people with IPF and other fibrotic disorders. By blocking autotaxin, and dampening the release of pro-fibrotic signals, cudetaxestat is expected to lessen tissue scarring.

preclinical study in rats showed that cudetaxestat did not interact with Ofev and had no detrimental impact on its concentration and activity.

A recently completed a Phase 1 trial (NCT04814472) in healthy volunteers also showed that cudetaxestat’s original oral solution had similar pharmacological properties and an identical safety profile to those of a new tablet formulation.

Another Phase 1 trial (NCT04814498), underway in Australia, is assessing the interactions between cudetaxestat and a combination of probe substrates for liver CYP450 enzymes, which are known to play a major role in the processing of certain medicines. According to Blade, this study is on track to be completed later this year.

“We are encouraged by the recent achievement of several development milestones for cudetaxestat and look forward to executing on the planned path ahead,” Robbins said.

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