Topline Results Released on IMG-007 Monoclonal Antibody for Alopecia Areata

New topline phase 2a findings have been announced by Inmagene Biopharmaceuticals, demonstrating positive results following treatment with a humanized IgG1 monoclonal antibody known as IMG-007 in patients with severe alopecia areata.1

The April 24 announcement by Inmagene pointed to a dose-related clinical activity of hair regrowth following treatment with IMG-007 over 4 weeks, including Severity of Alopecia Tool (SALT) score improvements following treatment with IMG-007. IMG-007 is a humanized IgG1 monoclonal antibody designed to target OX40, a molecule central to T cell activation, processes implicated in conditions such as alopecia.

“[Alopecia areata] is an [immunological and inflammatory] disease with tremendous unmet needs, especially for drugs with more favorable safety profiles,” Jonathan Wang, PhD, founder, chairman and CEO of Inmagene, said in a statement.1

The anti-OX40 antibody is designed to be administered subcutaneously, with a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function included in the treatment. It also maintains an extended half-life, avoiding the depletion of targeted cells. During the phase 2a study (NCT06060977), investigators used a multiple ascending dose trial design and conducted their analysis at 11 sites within Canada and the US.

There were 29 adult trial participants in the study who reported having at least 50% loss of scalp hair, evaluated via the SALT scoring system. The investigators split those involved into 2 cohorts. Cohort 1, made up of 6 patients, was provided with up to 3 intravenous doses of 300 mg that were also administered at the point of baseline, the 2-week mark, and the 4-week mark.

For the 23 subjects included in Cohort 2, the same schedule with a 600 mg dose was provided. In both arms of the analysis, subjects were monitored through the 24-week mark, with 16 from Cohort 2 continuing through an optional follow-up to the 36-week mark. The average duration of the current alopecia areata episode at the beginning of the study was noted as 3 years.

At the same time point, the mean SALT score was shown to be 80.4. 31% of the 29 participants reported having a SALT scores of 95 or above at baseline. The investigative team took biopsies from both lesional and non-lesional scalp regions at the point of baseline and then again at the 16-week mark to evaluate inflammatory biomarkers.

In their primary endpoints, the team looked into safety assessments and shifts in participants’ SALT scores from baseline over the study’s course.

The 4-week treatment period concluded with a dose-dependent response in hair regrowth being observed by the investigators, with Cohort 1 showing a minimal reduction in average SALT scores.1 Specifically, just 1.1% at the 24-week mark was highlighted.

In contrast, those in the second arm of the study reported having more substantial improvements in regrowth, showing a mean reduction in SALT scores of 14.3% at the 24-week mark and 21.7% by the 36-week mark.1 Significantly, the improvement trend was found by the investigators not to have plateaued by Week 36.

Additionally, they found that 25% of Cohort 2 participants were shown to have attained a ≥30% reduction in their SALT scores by the 36-week mark. More pronounced clinical benefits were found in Cohort 2, among those with baseline SALT scores between 50 - 95 specifically.

At baseline, the subjects’ scalp samples from lesional areas revealed heightened expression of inflammatory markers associated with Th1, Th2, and CD8+ T cells relative to non-lesional areas of the scalp. Three months following the participants’ last 600 mg dose, at the 16-week mark, IMG-007 therapy was found to be linked with significant suppression of such inflammatory signals.

The team noted that IMG-007 was well-tolerated among the patients involved in the study, with a lack of serious adverse events (SAEs) being reported.1 All treatment-emergent adverse events (TEAEs) were also categorized by the investigators as being mild or moderate.

The most frequently reported TEAEs included nasopharyngitis (10.3%), headaches (13.8%), hypertension (6.9%), and streptococcal infections (6.9%). They found there had not been incidences of fever or chills among participants.

“The marked and durable clinical and pharmacodynamic activities observed in Cohort 2 after a 4-week treatment, combined with a well-tolerated profile, suggest that blocking the OX40-OX40L signaling may be a novel approach to the treatment of [alopecia areata],” Wang said in a statement.1

References

1. Inmagene Reports Topline Results from Phase 2a Study of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, in Patients with Alopecia Areata. Inmagene Biopharmaceuticals. April 24, 2025. https://www.globenewswire.com/news-release/2025/04/24/3067491/0/en/Inmagene-Reports-Topline-Results-from-Phase-2a-Study-of-IMG-007-a-Nondepleting-Anti-OX40-Monoclonal-Antibody-with-an-Extended-Half-life-in-Patients-with-Alopecia-Areata.html.