FDA OKs Clinical Trial Testing Cudetaxestat With Ofev, Esbriet

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by Marisa Wexler MS |

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The U.S. Food and Drug Administration (FDA) has authorized Blade Therapeutics to begin a Phase 1 clinical trial evaluating pharmacological interactions between its investigational medication, cudetaxestat (BLD-0409), and two approved treatments for idiopathic pulmonary fibrosis (IPF).

The trial will enroll an estimated 86 healthy individuals, who will be given cudetaxestat alone, or in combination with either Ofev (nintedanib) or Esbriet (pirfenidone), both oral medications with FDA approval for IPF.

The study’s main goal is to determine how combining these treatments affects their pharmacokinetics, or the way they move in, through, and out of the body.

Blade is planning to open the trial (NCT04939467) in the U.S. later this year, though the study site has not been announced.

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Results from the Phase 1 trial will be used to inform the design of a planned Phase 2 study that will assess the safety and efficacy of cudetaxestat in people with IPF. That trial is planned for launch in the first half of next year, Blade said.

“We are excited about this important regulatory step that supports the development path for cudetaxestat, a highly differentiated small-molecule investigational therapy that targets a clinically validated pathway in IPF,” Wendye Robbins, MD, Blade’s president and CEO, said in a press release.

“We are focused on advancing cudetaxestat in pursuit of our mission to bring life-changing treatments to patients with intractable diseases,” Robbins added.

Cudetaxestat works by blocking the activity of an enzyme called autotaxin. This enzyme helps to produce a signaling fatty molecule, called lysophosphatidic acid (LPA), which is a potent driver of fibrosis, or tissue scarring.

According to Blade, autotaxin levels and activity are often elevated in people with IPF and other fibrotic diseases. Thus, by inhibiting autotaxin, cudetaxestat is expected to help reduce tissue scarring.

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The FDA designated cudetaxestat an orphan drug as a potential treatment for IPF in February of this year. This designation is normally given to medicines that have the potential to improve care for people with rare diseases. It also grants Blade, as the therapy’s developer, incentives like tax credits, fee waivers, and the potential for seven years of market exclusivity upon treatment approval.

Blade has completed a Phase 1 trial (NCT04146805) that tested one and multiple doses of cudetaxestat in healthy volunteers. Results showed the experimental therapy had good safety and tolerability profile.

The company also is conducting two additional Phase 1 trials of the medication in healthy volunteers, both of which are expected to conclude later this year. One of the studies (NCT04814472), involving 34 participants, is comparing the properties of a new tablet formulation of cudetaxestat with the current oral solution formulation. The other (NCT04814498) is testing the effect of cudetaxestat on the pharmacokinetics of a combination of probe substrates for CYP450 enzymes — liver enzymes that play a major role in metabolizing, or processing, medications.

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