A new phase 2 clinical trial will evaluate the safety and efficacy of AMB-05X in patients with idiopathic pulmonary fibrosis (IPF).

The randomized, placebo-controlled, multicenter study aims to enroll around 36 patients, aged 40 years and over. Participants will receive 6 doses of AMB-05X or placebo over a 24-week dosing period.

The primary outcome measure will be treatment-emergent adverse events. Secondary outcome measures include pulmonary function, pharmacodynamics, the change in health-related quality of life, and peak plasma concentration measurements.


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Patients who have a forced vital capacity of 45% or more predicted normal plus a diffusing capacity for carbon monoxide between 25% and 90% predicted, a Tiffeneau-Pinelli index of at least 0.70, and adequate hematologic, hepatic, and renal function are eligible to take part in the study.

Read more about the etiology of IPF

Those who have emphysema exceeding the extent of fibrosis, active or anticipated need for a lung transplant, active cancer, active or chronic infection with hepatitis C virus, hepatitis B virus, or HIV, active tuberculosis, and lower respiratory tract infection requiring antibiotic therapy are not eligible. Patients who smoke, have a history of drug or alcohol abuse, and are being treated with prednisone are also not eligible to participate in the trial. Full eligibility criteria can be found on the trial website.

The study that is sponsored by AmMax Bio, Inc. is not yet recruiting participants. The estimated study start date is July 2022. The estimated completion date is February 2024.

AMB-05X is a fully human monoclonal immunoglobulin against colony-stimulating factor 1 receptor, which is thought to play a critical role in the pathogenesis of IPF. The exact cause of IPF is not known but it is thought that acute lung injury and early inflammation lead to aberrant macrophage differentiation, wound healing responses, and pulmonary fibrosis.

Reference

A phase 2 study to evaluate safety and efficacy of AMB-05X in subjects with idiopathic pulmonary fibrosis. US National Library of Medicine. Updated April 27, 2022. Accessed May 2, 2022.