Endeavor completes enrollment in Phase 2 trial testing ENV-101

Potential idiopathic pulmonary fibrosis treatment would halt lung fibrosis

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by Steve Bryson, PhD |

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A Phase 2a clinical trial to evaluate the safety and efficacy of ENV-101 (taladegib), Endeavor BioMedicines’ oral treatment for idiopathic pulmonary fibrosis (IPF), has completed patient enrollment.

Top-line data from the study (NCT04968574), which enrolled 41 adults with mild-to-moderate IPF, ages 40 and older, at sites in Canada, Australia, South Korea, Malaysia, and Mexico, is expected early 2024.

“Completing enrollment in the ENV-101 IPF study brings us one step closer to delivering an urgently needed therapy with the potential to treat the underpinnings of the disease and halt the progression of fibrosis [tissue scarring],” John Hood, PhD, Endeavor’s co-founder, CEO, and chairman, said in a company press release.

“This enrollment milestone is an important achievement, and we look forward to reporting topline results in [the first quarter] of 2024,” Hood said. “I would like to thank the patients participating and the clinical trial sites for working tirelessly to advance the study to this point.”

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IPF often slow to be diagnosed in US, proper treatment lacking

IPF is a disease marked by fibrosis, or scarring, of the lungs, making it difficult for patients to breathe. Scarring is mainly driven by the overactivation of cells called myofibroblasts, which are regulated by the Hedgehog pathway, a signaling cascade involved in wound healing and cell growth.

ENV-101 is an orally available small molecule designed to suppress the Hedgehog pathway, with the potential to eliminate the key cellular driver of IPF and halt, and possibly reverse, lung fibrosis.

ENV-101 also being developed for use in cancer treatment

The experimental therapy also is being developed as a potential treatment for Hedgehog-driven cancers. According to Endeavor, data from nearly 200 people who participated in six clinical trials of ENV-101 showed the therapy can safely and effectively block Hedgehog signaling as intended.

In the ongoing Phase 2a trial, which dosed its first patient in 2021, the 41 enrolled participants will be randomly assigned to receive a 200 mg oral tablet of ENV-101, or a placebo, daily for about three months.

Standard IPF therapies, such as Ofev (nintedanib) and Esbriet (pirfenidone), will not be allowed in the 30 days leading up to the trial, nor during the study. Following treatment, participants will be followed for an additional period of six weeks.

Assessing the frequency and severity of adverse events are the trial’s primary goals, alongside changes in patients’ vital signs and incidence of clinical laboratory abnormalities. Secondary goals include assessing the effects of treatment on validated measures of lung function and shortness of breath.

Last year, Endeavor raised $101 million to advance its pipeline programs, and $62 million in 2021 to support the launch of clinical studies.

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