New Phase 2a Findings Released on IMG-007 Treatment of Atopic Dermatitis

Positive results were announced by Inmagene Biopharmaceuticals from a phase 2a clinical study assessing IMG-007 treatment of individuals with moderate-to-severe atopic dermatitis, including a 4-week finding that treatment led to a mean reduction in eczema area and severity index (EASI) of 77% and an EASI-75 of 54% by 16 weeks.1

These data were announced on January 9 alongside results from a phase 1 analysis of the subcutaneous formulation of IMG-007. IMG-007 itself is designed as a nondepleting anti-OX40 monoclonal antibody (mAb) which has an extended half-life and also has a silenced antibody-dependent cellular cytotoxicity (ADCC) function that helps to minimize risk potential.

“The positive topline results from the Phase 2a trial of IMG-007 in patients with [atopic dermatitis] are exciting,” Yufang Lu, MD, PhD, Inmagene’s chief medical officer, said in a statement. “The robust observed clinical activity and biomarker data that resulted from a short 4-week treatment, as well as the well-tolerated safety profile, suggest that the ADCC silencing of IMG-007 has retained desired biological activity of OX40 blockade while improving the tolerability.”1

The research team’s findings resulted from a phase 2a open-label study (NCT05984784) looking at adult patients with atopic dermatitis seen in 13 patients across centers located within Canada and the US. The study assessed IMG-007’s pharmacokinetic data, safety findings, and efficacy as an intravenous treatment for patients with this skin condition.

Administration of IMG-007 was provided to study subjects in 3 doses at the 0, 2, and 4-week marks. Following the treatment, notable improvements were observed in clinical activity determined using EASI and several other outcome assessments, aligning with prior data announced by the company.2

Following a course of 4 weeks of administration of IMG-007, trial investigators observed at the 16-week mark that mean percent change of EASI and the EASI-75 responses were 77% and 54%, respectively.1 These results were noted by the investigative team as being within the range demonstrated by other investigational OX40/OX40L-targeting mAbs known to have a longer duration.

The researchers also observed durable inhibition of serum inflammatory markers of diverse T helper (Th) cells among patients, including Th1, Th2 and Th17 cells, and this was noted for up to 24 weeks of treatment.1 Overall, the team reported the trial led to no adverse events leading to treatment discontinuation, no events labeled as serious, and no treatment-related events. Specifically, the investigators highlighted a lack of reports of pyrexia or of chills.

Separately, Inmagene described their recent phase 1 trial (NCT06304740) designed to assess IMG-007’s subcutaneous formulation pharmacokinetics and safety profile, evaluating the medication’s use in 16 healthy adult subjects.

The research team found that the pharmacokinetic profile of this formulation was shown to be consistent with the profile of the intravenous formulation of IMG-007. The team highlighted that 1 subcutaneous IMG-007 dose demonstrated a mean terminal half-life of 34.7 days, noting that this is far longer than the half-life of other OX40/OX40L mAbs which they describe as being in clinical development.1

The investigators additionally expressed that IMG-007’s subcutaneous formulation was well-tolerated and had strong safety data, with the most commonly-noted AEs—specifically injection site reactions—being noted as more frequent among those in the placebo arm of the study (75%) compared to the IMG-007 arm (25%).1

“[Atopic dermatitis] is a chronic relapsing disease that requires long-term management, and currently approved biologics require frequent injections, every 2 or 4 weeks,” Lu said in a statement. “The extended half-life of IMG-007 [subcutaneous] formulation coupled with a favorable tolerability profile would potentially allow for IMG-007 to provide differentiated dosing regimens in the long-term treatment of [atopic dermatitis].”1

References

1. Inmagene Reports Positive Topline Results of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-Life, for the Treatment of Atopic Dermatitis. Inmagene Biopharmaceuticals. January 9, 2024. https://www.globenewswire.com/news-release/2025/01/09/3007096/0/en/Inmagene-Reports-Positive-Topline-Results-of-IMG-007-a-Nondepleting-Anti-OX40-Monoclonal-Antibody-with-an-Extended-Half-Life-for-the-Treatment-of-Atopic-Dermatitis.html. Date accessed: January 9, 2024.
2. Inmagene Reports Positive Interim Results from Phase 2a Trial of IMG-007, a Nondepleting Anti-OX40 Monoclonal Antibody with an Extended Half-life, for the Treatment of Atopic Dermatitis. Inmagene Biopharmaceuticals. May 6, 2024. https://www.biospace.com/inmagene-reports-positive-interim-results-from-phase-2a-trial-of-img-007-a-nondepleting-anti-ox40-monoclonal-antibody-with-an-extended-half-life-for-the-treatment-of-atopic-dermatitis. Date accessed: January 9, 2024.