ENV-101 is intended for the treatment of idiopathic pulmonary fibrosis. Credit: mi_viri / Shutterstock.

Endeavor BioMedicines has concluded patient enrolment in a Phase IIa clinical trial of ENV-101 (taladegib) to treat idiopathic pulmonary fibrosis (IPF).

The multi-centre, placebo-controlled, randomised study is being carried out in Mexico, Canada, and the Asia-Pacific region.

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It intends to assess the efficacy and safety of the Hedgehog (Hh) signalling pathway inhibitor ENV-101 in patients with mild-to-moderate IPF.

A total of 41 participants aged 40 years and above will receive daily ENV-101 as a monotherapy or placebo for 12 consecutive weeks.

They will also be observed for an additional six weeks following the treatment with ENV-101.

A change from baseline in frequency, severity of adverse events, and a change in key vital sign measurements are the primary endpoints of the study.

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Secondary endpoints include a change in forced vital capacity and other measures of lung function.

Endeavor BioMedicines co-founder, CEO and chairman John Hood said: “Completing enrolment 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.

“This enrolment milestone is an important achievement, and we look forward to reporting topline results in Q1 of 2024.”

The company’s lead programme, ENV-101 is a small-molecule agent that induces myofibroblast apoptosis and eliminates the key cellular driver of IPF.

Last May, the company dosed the first patient in its open-label Phase II study of ENV-101 to treat advanced solid tumours harbouring Patched-1 (PTCH1) loss of function mutations.