Endeavor completes its Phase 2a trial testing ENV-101 in IPF patients

To launch this year, Phase 2b trial will include progressive fibrosing ILD patients

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A Phase 2a clinical trial has finished testing the experimental therapy ENV-101 (taladegib) in people with idiopathic pulmonary fibrosis (IPF), according to its developer, Endeavor BioMedicines.

Endeavor did not include in its announcement any specific data from the trial, but John Hood, PhD, the company’s co-founder, CEO, and chairman, expressed optimism.

“Preliminary results from our Phase 2a trial reinforce our belief that ENV-101 has the potential to be the first ever disease-modifying therapy for IPF,” Hood said in a company press release. “We are hopeful that the therapeutic capability of ENV-101 will offer treatment outcomes that go beyond slowing disease progression for patients with lung fibrosis.”

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Endeavor planning to present full trial data at upcoming medical conference

The company is planning to present full data from the trial at an upcoming medical conference.

IPF is characterized by scarring, or fibrosis, in the lungs. Scar tissue makes the lungs stiffer so it’s harder for them to inflate and take in oxygen — all of which leads to breathing problems and related symptoms.

Scarring in IPF is driven by the excessive activity of cells called myofibroblasts. These cells are regulated by a molecular signaling cascade called the Hedgehog pathway, which is involved in wound healing and scar formation. This pathway got its name because it was first discovered in fruit flies, where mutations in genes involved in the pathway caused fly larvae to have a spiky appearance akin to a hedgehog.

ENV-101 is an oral therapy designed to block Hedgehog signaling. By doing so, the experimental medication is expected to reduce the production of scar tissue, and potentially reverse fibrosis.

The Phase 2a trial (NCT04968574) assessed the effects of about three months of daily ENV-101 treatment against a placebo in 41 adults with IPF. The first patient was dosed in 2021, and the study finished recruitment last year. The trial’s main goal was to evaluate ENV-101’s safety profile in IPF patients. The treatment’s effect on lung function measures was also tested.

Endeavor is developing ENV-101 also as a potential treatment for other disorders characterized by lung scarring, broadly referred to as progressive fibrosing interstitial lung diseases. The company is planning to launch a new trial soon to further explore the effects of the therapy.

“We look forward to expanding ENV-101 clinical development activity by initiating a randomized, double-blind, dose-ranging Phase 2b trial in patients with IPF and in a parallel cohort of patients with progressive fibrosing-interstitial lung disease in 2024 to evaluate its broader therapeutic potential,” said Paul Frohna, MD, PhD, chief medical officer of Endeavor.

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