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News|Articles|October 15, 2023

First Patient Dosed in Phase 2a Trial of IMG-007 for Alopecia Areata

Inmagene recently announced the first patient was dosed in its study of the efficacy and safety of IMG-007 in hair loss.

Inmagene Biopharmaceuticals recently announced1 that the first patient has been dosed in the company's phase 2a trial evaluating the safety, efficacy, and pharmacokinetics, and biomarkers of IMG-007 in adult patients with alopecia areata and 50% of greater hair loss on the scalp.

The OX40 receptor-binding humanized IgG1 monoclonal antibody previously demonstrated a favorable safety profile in a phase 1 study.

The current, ongoing interventional study (NCT06060977) will consist of 2 patient cohorts. Patients will be involved in a 5-week screening period, a 16-week treatment period, and and 8-week follow-up period.

Each cohort will receive 3 intravenous infusions of IMG-007 every 4 weeks.

Key Takeaways

  • Inmagene Biopharmaceuticals recently dosed the first patient in a phase 2a trial of IMG-007, a humanized monoclonal antibody, for treating alopecia areata with 50% or greater hair loss on the scalp.
  • The study will assess safety, pharmacokinetics, and biomarkers, with each patient receiving 3 intravenous infusions of IMG-007 every 4 weeks, potentially offering a once-every-12-week dosing regimen for alopecia areata patients.

While the evaluation of adverse events in participants is considered a primary outcome measure, the study will also explore pharmakinetic characterization in both central compartment clearance and central compartment volume, as well as efficacy measured by the Evaluation of Severity of Alopecia Tool.

"Alopecia areata (AA) is a devastating disease which affects approximately 147 million people globally. Currently, there are limited treatment options and no approved biologics for AA. Better treatment options are needed," said Jonathan Wang, PhD, chief executive officer of Inmagene.1 "IMG-007 could potentially provide a safe and effective biologic therapy with once every 12 weeks dosing regimen for AA patients."

In addition to the study of IMG-007 in alopecia areata, IMG-007 is currently being evaluated in a phase 2a study involving adult patients with atopic dermatitis.

Read previous Dermatology Times coverage of the IMG-007 study for atopic dermatitis here.

Reference

  1. Inmagene. Inmagene doses first patient in phase 2A trial of IMG-007, an Anti-OX40 monoclonal antibody with an extended half-life, for the treatment of alopecia areata. PR Newswire: press release distribution, targeting, monitoring and marketing. October 13, 2023. Accessed October 13, 2023. https://www.prnewswire.com/news-releases/inmagene-doses-first-patient-in-phase-2a-trial-of-img-007-an-anti-ox40-monoclonal-antibody-with-an-extended-half-life-for-the-treatment-of-alopecia-areata-301956087.html

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