FDA clears clinical trial of Mabwell’s IL-11 antibody therapy for IPF

Current Phase 1 trial in Australia testing safety of 9MW3811 in healthy adults

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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The U.S. Food and Drug Administration has given the green light for Mabwell Therapeutics to launch a clinical trial testing 9MW3811, its injectable treatment candidate for idiopathic pulmonary fibrosis (IPF) and cancer, according to a company press release.

Last month, the National Medical Products Administration in China also cleared a clinical trial of the investigational therapy.

Currently, the first in-human Phase 1 study of 9MW3811 (NCT05740475) is ongoing at a single site in Australia. The study is testing 9MW3811’s safety and tolerability in up to 32 healthy adults, ages 18-55.

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Design and launch date of potential U.S. trial not yet disclosed

Participants will be split into four dosing groups of eight people each. In each group, six people will receive a single into-the-vein injection of their assigned 9MW3811 dose, while the remaining two people will receive a placebo injection.

The study’s main goal is to assess the treatment’s safety. Mabwell believes the treatment candidate will have a good safety profile based on existing data. The therapy’s pharmacological properties will also be evaluated. The trial is expected to finish in September.

The design and launch date of a potential U.S. trial has not been disclosed.

9MW3811 is a monoclonal antibody designed to target interleukin-11 (IL-11), an immune signaling molecule that’s been implicated in the scar tissue buildup (fibrosis) and inflammation that characterize IPF.

IL-11 is produced at high levels by fibroblasts, a type of connective tissue cell, from the lungs of IPF patients, where it leads to the activation of genes that promote fibrotic signaling processes.

In mice, increasing IL-11 production leads to the development of IPF, and blockade of the molecule can reverse signs of IPF in animals with existing disease.

As such, IL-11 has earned increasing attention in recent years as a treatment target for IPF. Other experimental treatment candidates, such as Lassen Therapeutics’ LASN01, also target IL-11.

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Preclinical studies indicate that 9MW3811 can strongly bind to IL-11 and block the activation of its downstream signaling pathways, which is expected to prevent fibrosis. The experimental therapy was shown to significantly reduce lung fibrosis, lower the levels of collagen — a connective tissue protein implicated in fibrosis — and improve lung function in a mouse model of fibrosis.

Those findings overall make it “a promising therapeutic agent for idiopathic pulmonary fibrosis and other diseases,” Mabwell noted in its press release.

The treatment is also being developed for cancer, where IL-11 has similarly been implicated. 9MW3811 was found to have anti-cancer effects in tumor models, where it could regulate the interaction between tumor cells and certain types of immune cells, thereby boosting the infiltration of immune T-cells that can fight off cancer.

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