A phase 2 clinical trial evaluating the safety and efficacy of taladegib (ENV-101) in patients with idiopathic pulmonary fibrosis (IPF) dosed its first participant, according to a press release by Endeavor BioMedicines, the developer of the treatment.
Taladegib is an inhibitor of the Hedgehog signaling pathway, which is known to play a critical role in the pathology of IPF.
John Hood, PhD, the cofounder, chief executive officer, and chairman of Endeavor, stated, “This phase 2 study now underway will help us understand how taladegib may help to stop or even reverse one of the most devastating pulmonary diseases by targeting the Hedgehog pathway.” He added, “This precision therapy approach targets the underpinnings of the disease rather than solely the symptoms patients face.”
The randomized, placebo-controlled, multicenter study aims to enroll 60 participants aged 40 years and above with mild to moderate IPF. They will randomly receive either a placebo or oral taladegib for 12 weeks. They will then be followed up for an additional 6 weeks.
Read more about IPF therapies
The primary endpoints are changes from baseline in the frequency and severity of adverse events, vital sign measurements (pulse, blood pressure, respiration rate, and temperature), blood oxygen saturation levels, incidence and severity of clinical laboratory abnormalities, and the number of hospitalizations.
The secondary endpoints are measures of lung function such as changes from baseline of forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), diffusing capacity of the lungs for carbon monoxide (DLCO), and patient-reported outcomes in shortness of breath at weeks 6, 12, and 18.
The trial started in August 2021 and is currently enrolling participants in 3 states in Australia (New South Wales, Queensland, and Victoria). It is estimated to be completed in March 2022.
Depending on the results of the trial, the company anticipates starting another phase 2 trial of taladegib in combination with standard of care by 2022.
Endeavor BioMedicines doses first patient in phase 2 clinical trial of taladegib (ENV-101) for idiopathic pulmonary fibrosis; appoints chief medical officer. News release. Endeavor Biomedicines; September 22, 2021.
A study evaluating the safety and efficacy of ENV-101 in subjects with idiopathic pulmonary fibrosis (IPF). ClinicalTrials.gov. July 20, 2021. Updated August 20, 2021. Accessed September 24, 2021.