Endeavor BioMedicines has dosed the first subject in the randomised Phase IIb WHISTLE-PF trial in Australia, assessing the efficacy and safety of ENV-101 (taladegib), an investigational drug for treating idiopathic pulmonary fibrosis (IPF).
The Phase IIb ‘Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF’ (WHISTLE-PF) global trial will be conducted across 14 countries, along with Australia.
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Over a 24-week treatment period, the WHISTLE-PF trial is set to assess various dosages of ENV-101, its impact on patient-reported results, and its effects on lung capacity and fibrosis, as measured by chest high-resolution computed tomography (HRCT).
ENV-101 has shown promise in earlier trials as the first disease-modifying treatment for this indication.
The Phase IIa placebo-controlled, double-blind trial outcomes for ENV-101 demonstrated statistically significant improvements in lung function and capacity, with patients experiencing a reversal of key measures of fibrosis over 12 weeks of treatment.
Notably, no serious adverse events or safety concerns related to the treatment were reported.
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By GlobalDataEndeavor BioMedicines CEO, co-founder and chairman John Hood said: “Initiating the WHISTLE-PF trial is an important milestone for our company as we continue to develop ENV-101 for the treatment of IPF, a relentless disease that has a worse prognosis than most cancers.
“Following the positive results from our Phase IIa trial of ENV-101, Endeavor BioMedicines is now intensely focused on efficiently advancing the WHISTLE-PF trial to get this potentially transformative drug to patients as quickly as possible.”
IPF is a progressive and serious lung disease affecting approximately 150,000 adults in the US. The disease is characterised by lung scarring and a decline in lung function, with current treatments only able to slow the progression rather than stop or reverse it.
ENV-101 aims to address this gap by targeting the Hedgehog pathway, which is implicated in the abnormal wound-healing process that leads to lung fibrosis.
Update: This article has been updated to differentiate between the Phase IIa trial data and the ongoing Phase IIb WHISTLE-PF trial.
