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).
ENV-101 has shown promise in earlier trials as the first disease-modifying treatment for this indication.
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The placebo-controlled, double-blind ‘Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF’ (WHISTLE-PF)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.
The global trial will be conducted across 14 countries, along with Australia.
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).
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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.
