IMG-007 Alopecia Areata: Topline Results Released

IMG-007 Shows Promise for Alopecia Areata Treatment in Phase 2a Trial

Inmagene Biopharmaceuticals reports positive results from a Phase 2a study of IMG-007, a potential new treatment for severe alopecia areata, offering hope for those seeking hair regrowth.

May 2, 2025

novel Antibody Shows Hair regrowth Potential

Inmagene Biopharmaceuticals announced April 24 positive topline findings from its Phase 2a clinical trial of IMG-007, a humanized IgG1 monoclonal antibody, in patients with severe alopecia areata. The study demonstrated dose-related clinical activity, specifically hair regrowth, following four weeks of treatment. Improvements were measured using the Severity of Alopecia Tool (SALT) score.

IMG-007 targets OX40, a molecule central to T cell activation, a process implicated in the development of alopecia areata. The drug is designed for subcutaneous administration and features a silenced antibody-dependent cell-mediated cytotoxicity (ADCC) function, which avoids the depletion of targeted cells. It also boasts an extended half-life.

Did you know? Alopecia areata affects approximately 6.8 million people in the United States, according to the National Alopecia Areata Foundation. It can occur at any age and affects both men and women.

Study Design and Key findings

The Phase 2a study (NCT06060977) employed a multiple ascending dose trial design and was conducted at 11 sites in Canada and the U.S. The trial involved 29 adult participants with at least 50% scalp hair loss, as measured by the SALT scoring system.Participants were divided into two cohorts.

Cohort 1 (six patients) received up to three intravenous doses of 300 mg of IMG-007 at baseline, two weeks, and four weeks. Cohort 2 (23 patients) received the same schedule but with a 600 mg dose. Both cohorts were monitored for 24 weeks, with 16 participants from Cohort 2 continuing to an optional follow-up at 36 weeks. The average duration of the current alopecia areata episode at the study’s start was three years, and the mean SALT score was 80.4. Nearly a third (31%) of participants had SALT scores of 95 or higher at baseline.

Researchers collected biopsies from both lesional and non-lesional scalp regions at baseline and at 16 weeks to assess inflammatory biomarkers. The primary endpoints were safety assessments and changes in SALT scores from baseline throughout the study.

Dose-Dependent Hair Regrowth Observed

Investigators observed a dose-dependent response in hair regrowth after the four-week treatment period. Cohort 1 showed a minimal average SALT score reduction of just 1.1% at the 24-week mark. In contrast, Cohort 2 experienced more considerable improvements, with a mean SALT score reduction of 14.3% at 24 weeks and 21.7% at 36 weeks. The improvement trend in Cohort 2 did not plateau by Week 36.

Furthermore, 25% of Cohort 2 participants achieved a ≥30% reduction in their SALT scores by Week 36. The study found more pronounced clinical benefits in cohort 2, particularly among those with baseline SALT scores between 50 and 95.

Pro tip: The SALT score is a tool used by dermatologists to measure the percentage of scalp area affected by alopecia areata. A lower SALT score indicates more hair regrowth.

Impact on Inflammatory Markers

Scalp samples from lesional areas at baseline showed heightened expression of inflammatory markers associated with Th1, Th2, and CD8+ T cells compared to non-lesional areas. At the 16-week mark, three months after the last 600 mg dose, IMG-007 therapy was linked to notable suppression of these inflammatory signals.

Safety and Tolerability

IMG-007 was well-tolerated among study participants, with no serious adverse events (SAEs) reported. All treatment-emergent adverse events (TEAEs) were categorized as mild or moderate. The most frequently reported TEAEs included nasopharyngitis (10.3%), headaches (13.8%), hypertension (6.9%), and streptococcal infections (6.9%). There were no incidences of fever or chills among participants.

Expert Commentary

Jonathan Wang,PhD,founder,chairman and CEO of Inmagene,stated,“[Alopecia areata] is an [immunological and inflammatory] disease with tremendous unmet needs,especially for drugs with more favorable safety profiles.” He added, “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 might potentially be a novel approach to the treatment of [alopecia areata].”

Counterarguments and Considerations

While the Phase 2a results are promising, it’s important to acknowledge the limitations of the study. The small sample size (29 participants) necessitates caution when generalizing the findings to the broader population of individuals with alopecia areata. Additionally, the study duration of 36 weeks, while showing continued improvement, may not be sufficient to fully assess the long-term efficacy and safety of IMG-007. Further,larger,randomized,placebo-controlled Phase 3 trials are needed to confirm these findings and establish the drug’s effectiveness definitively.

Next Steps

Inmagene Biopharmaceuticals is expected to proceed with further clinical trials to evaluate the efficacy and safety of IMG-007 in a larger patient population. these future trials will be crucial in determining the potential of IMG-007 as a viable treatment option for alopecia areata.

FAQ About Alopecia Areata and IMG-007

Question	Answer
What is alopecia areata?	Alopecia areata is an autoimmune disorder that causes hair loss, often in patches, and affects millions of people in the U.S.
How does IMG-007 work?	IMG-007 is a humanized monoclonal antibody that targets OX40, a key molecule in T cell activation and inflammation, processes believed to contribute to alopecia areata.
What were the main findings of the Phase 2a trial?	The trial showed dose-related hair regrowth in patients treated with IMG-007, with a higher dose (600mg) resulting in a more significant reduction in SALT scores (indicating more hair growth) compared to a lower dose (300mg).
Are there any side effects associated with IMG-007?	In the Phase 2a trial, IMG-007 was well-tolerated. The most commonly reported side effects were mild to moderate, including nasopharyngitis, headaches, hypertension, and streptococcal infections.
When will IMG-007 be available to patients?	IMG-007 is still in clinical development. Its availability depends on the successful completion of further clinical trials and regulatory approval.

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What are the limitations of the Phase 2a trial of IMG-007, and what are the next critical steps for Inmagene Biopharmaceuticals?

IMG-007: A Promising New Treatment for Alopecia Areata? An Interview with Dr. evelyn Reed

Introduction

Welcome to Archyde.com. Today, we’re delving into the exciting results of the Phase 2a trial of IMG-007, a potential new treatment for alopecia areata. we have Dr. Evelyn Reed, a leading dermatologist specializing in autoimmune diseases, to give us her expert insights. Dr. Reed, thank you for joining us.

Understanding the Phase 2a Trial

Archyde: Dr. Reed, the Phase 2a trial results for IMG-007 seem very promising. Can you explain in laymanS terms how IMG-007 is designed to work against alopecia areata?

Dr. Reed: Certainly.The core issue in alopecia areata is an overactive immune system, specifically T cells, attacking the hair follicles. IMG-007 is a humanized monoclonal antibody that targets OX40, a key molecule responsible for activating these T cells. By blocking OX40, IMG-007 aims to quiet down the inflammatory process that leads to hair loss, allowing the follicles to recover and hair to regrow.

Key Findings and Dose-Dependency

Archyde: The study showed a dose-dependent response. The higher dose (600mg) showed considerably better results. what’s your take on the dosage difference and its implications?

Dr. Reed: The dose-dependent response is a crucial observation. It confirms that the drug is biologically active and working as intended, offering hope for effective hair regrowth in patients with this condition.. In fact, a 21.7% reduction in SALT score at 36 weeks demonstrated significant improvements, indicating the drug is able to substantially reduce hair loss.

Safety and Tolerability

Archyde: The article mentions that IMG-007 was well-tolerated with no serious adverse events. How significant is this in the context of developing new treatments?

Dr. Reed: Safety is paramount. the fact that IMG-007 showed a favorable safety profile, with only mild to moderate side effects, is highly encouraging. This suggests a good potential for broader use with a reduced risk of serious complications, a factor that boosts confidence in this potential treatment for alopecia areata. Common side effects such as nasopharyngitis, headaches, hypertension and streptococcal infections were recorded.

Limitations and Future Directions

Archyde: the article also points out some limitations, like the small sample size and study duration. What are the next critical steps for Inmagene Biopharmaceuticals in developing IMG-007 further?

Dr. Reed: You’re right to highlight the limitations. The next steps are crucial. Inmagene needs to conduct larger, Phase 3 trials involving more participants and longer follow-up periods.This will give us a more definitive picture of IMG-007’s long-term efficacy and safety. Further analysis on distinct population groups and comparing IMG-007 with current treatments are essential. These studies are crucial to determine if the drug can meet the market standard requirements to gain approval for commercial use.

broader Impact and Patient Expectations

Archyde: dr. Reed, what would you say to patients living with alopecia areata who might be seeing these results and are hoping for a new treatment?

Dr. Reed: The results are certainly a cause for optimism. This is a step forward.While we are thrilled with the outcome of IMG-007, it’s significant to stay grounded. Patients should approach the developments with informed optimism. it is essential for patients to talk about how new therapies will interact with their current lifestyle and health conditions. More studies will need to be conducted to confirm the drug’s effectiveness. Patience is key, as regulatory processes take time. Discussing the future with your doctor will help you understand the process and weigh personal choice on treatment. It’s also sensible to look ahead as to how the drug will integrate with other lifestyle choices for the long-term benefit of the patient’s health.

Concluding Remarks

Archyde: Dr. Reed, thank you so much for sharing your expertise. It’s been a very insightful discussion.

Dr. Reed: My pleasure. Thank you for having me.