Endeavor’s IPF Drug Linked to Improved Lung Function in Phase 2 Study

In a phase 2 study on idiopathic pulmonary fibrosis (IPF), Endeavor BioMedicines has linked its Hedgehog inhibitor to enhanced lung function.

Boehringer Ingelheim’s Ofev and Roche’s Esbriet became industry stalwarts based on evidence that they can reduce the loss of lung function. Around 70% of the participants in a crucial Ofev study who took the Boehringer medicine for 52 weeks saw a worsening in lung function. The Esbriet label includes information from a key trial where 77% of those who took the medication experienced a decline in lung function.

While Ofev and Esbriet achieved success by slowing the progression of IPF, Endeavor aims to go further and potentially reverse the illness. By targeting a specific kind of fibroblast believed to be responsible for causing IPF, the biotech hopes to achieve its goal, according to preliminary clinical data from the phase 2a study.

The study’s 41 participants were randomly assigned to either take ENV-101 or a placebo once daily for their IPF. Compared to baseline, Endeavor’s percent predicted forced vital capacity (ppFVC) improved by nearly 2% after 12 weeks. With a p-value of 0.035, the trial achieved its main goal, demonstrating a 1.3% decrease in ppFVC in the placebo group.

Additionally, Endeavor provided more evidence that ENV-101 has the potential to alter the disease’s trajectory. On average, the treatment group’s total lung capacity (TLC) rose by 200 mL, whereas the placebo group’s TLC fell by 56 mL. Moreover, 80% of ENV-101 patients had a rise in TLC, while 70% of placebo patients reported a reduction.

The biotech also evaluated lung fibrosis using imaging. The ENV-101 group had a 9.4% decrease in quantitative interstitial lung disease, a measure of lung fibrosis and other characteristics, while the placebo group had a 1.1% increase. Ground glass and quantitative lung fibrosis measurements also indicated that the research medication was more favorable.

During the course of the ENV-101 study, no patients experienced any treatment-related major adverse events, grade 3 or 4 adverse events, or clinically relevant safety issues on laboratory analysis and other evaluations. However, there were a few mild to moderate side effects that occurred frequently. Between 43% and 57% of the patients experienced changes in taste, hair loss, or muscle spasms after taking the drug.

Although the label for Ofev mentions hair loss (referred to as alopecia in the medical field), only 0.8% of patients experienced this condition. Similarly, dysgeusia (changes in taste) is listed on the label of Esbriet as it was experienced by 6% of those who took the medication. Endeavor is now preparing to conduct a second study with a global phase 2b IPF cohort as well as a parallel phase 2 group consisting of patients with progressive pulmonary fibrosis.

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