The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ImmunoMet Therapeutics‘ treatment candidate for idiopathic pulmonary fibrosis (IPF), IM156. The decision grants ImmunoMet permission to open studies of the therapy in people in the U.S.
“FDA clearance of an IND for IM156 is a major milestone for ImmunoMet,” Benjamin Cowen, CEO of ImmunoMet, said in a press release.
The company now plans to initiate a single-site Phase 1 study, which will test the investigational therapy in 32 healthy volunteers. This Phase 1 trial will aim to characterize IM156’s safety and tolerability, as well as its biological effects and its pharmacokinetic profile (the movement of a therapy into, through, and out of the body).
Findings from this study will be used to inform the design of a subsequent, Phase 2 trial in IPF patients.
The FDA also designated IM156 an orphan drug as a possible treatment of IPF.
This designation is given to therapies with the potential to improve treatment for rare diseases (conditions affecting fewer than 200,000 people in the U.S.). The designation makes ImmunoMet, as the therapy’s developer, eligible for benefits like tax credits and FDA funding toward clinical trial costs. The designation also grants seven years of market exclusivity in the U.S. if the treatment is ultimately approved.
IM156 is an oral medication that inhibits protein complex 1 (PC1), which is involved in cellular metabolic processes that are thought to drive fibrosis (scarring), as well as the growth of certain tumors. By blocking PC1, IM156 may lessen fibrosis and tumor growth.
Preclinical studies in animal models of fibrosis have shown that the therapy has a strong anti-fibrotic effect.
“The unique mechanism of action of IM156 has the potential to address an unmet need in patients with fibrotic disorders and complement the current standard of care,” Cowen said.
ImmunoMet is developing the medication as a treatment for IPF, as well as certain types of cancers.
IM156 was evaluated in a first-in-human clinical trial that enrolled 22 cancer patients (NCT03272256) and was conducted in Korea.
Results from this ImmunoMet-sponsored trial were published in the Journal of Clinical Oncology last year. The investigational medication was generally well-tolerated, with the most common treatment-related adverse events being nausea, diarrhea, and vomiting. Three participants experienced severe nausea; no other serious treatment-related adverse events were reported.
Findings from this early study also suggested some anti-cancer activity, and identified a dose for probable use in subsequent cancer studies.
“Based on results of our recently completed Korean Phase 1 trial of IM156 in oncology patients, we believe that it is the first potent PC1 inhibitor to complete a Phase 1 study with good tolerability,” Cowen said. “Our preclinical results further demonstrate a strong anti-fibrotic effect at doses previously shown to be well-tolerated in humans.”
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