The trial will assess intra-articular administration of the therapy in TGCT patients. Credit: KGH / commons.wikimedia.org.

AmMax Bio has announced the dosing of the first subjects in its Phase IIb clinical trial of AMB-05X to treat tenosynovial giant cell tumour (TGCT), a serious and debilitating locally aggressive tumour.

The trial has been designed for optimising the treatment regimen and evaluating the efficacy of a dosing period of more than six months.

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The open-label, dose-ranging, adaptive trial will assess the efficacy, safety, and pharmacokinetics of intra-articular administration of the therapy in TGCT patients following treatment for 24 weeks, and an additional long-term extension period.

AmMax Bio CEO Larry Hsu said: “The expansion of our TGCT programme into this Phase IIb study builds on the strong proof-of-concept safety and efficacy data reported in 2022, which evaluated the treatment of AMB-05X in TGCT patients over a 12-week period.

“Since announcing those results, both FDA Fast Track designation and EMA PRIME designation have been granted to AMB-05X, reflecting its significant potential to address the unmet medical need for this patient population with few treatment options.

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“With six months of treatment, we believe patients will receive greater benefit with AMB-05X than any other pharmacological options, and we plan to use the data from this trial to finalise our Phase III study design.”​

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Initial results from the Phase IIb trial are expected in the second half of this year.

AMB-05X is a potent monoclonal antibody against CSF1R and received Fast Track designation and PRIME designation from the FDA and EMA, respectively, for TGCT.

It represents a therapeutic platform that acts on serious macrophage-driven inflammatory, fibrotic, and neovascular diseases.