Positive results from a phase 2a clinical study assessing IMG-007 treatment for individuals with moderate-to-severe atopic dermatitis were announced by Inmagene Biopharmaceuticals. The study, which included a 4-week treatment period, led to a mean reduction in eczema area and severity index (EASI) of 77% and an EASI-75 of 54% by 16 weeks. IMG-007 is a nondepleting anti-OX40 monoclonal antibody (mAb) with an extended half-life and a silenced antibody-dependent cellular cytotoxicity (ADCC) function, designed to minimize risk potential.
The phase 2a open-label study (NCT05984784) involved adult patients with atopic dermatitis from centers in Canada and the US. It assessed IMG-007's pharmacokinetic data, safety findings, and efficacy as an intravenous treatment. Patients received IMG-007 in 3 doses at the 0, 2, and 4-week marks, leading to notable improvements in clinical activity as determined by EASI and other outcome assessments.
At the 16-week mark, trial investigators observed a mean percent change of EASI and EASI-75 responses of 77% and 54%, respectively. The study also noted durable inhibition of serum inflammatory markers of diverse T helper (Th) cells, including Th1, Th2, and Th17 cells, up to 24 weeks of treatment. The trial reported no adverse events leading to treatment discontinuation, no serious events, and no treatment-related events, with a particular lack of reports of pyrexia or chills.
Inmagene also conducted a phase 1 trial (NCT06304740) to assess the pharmacokinetics and safety profile of IMG-007's subcutaneous formulation in 16 healthy adult subjects. The pharmacokinetic profile of the subcutaneous formulation was consistent with the intravenous formulation, with a mean terminal half-life of 34.7 days, significantly longer than other OX40/OX40L mAbs in clinical development. The subcutaneous formulation was well-tolerated, with injection site reactions being more frequent in the placebo arm (75%) compared to the IMG-007 arm (25%).
Yufang Lu, MD, PhD, Inmagene’s chief medical officer, highlighted the potential of IMG-007's extended half-life and favorable tolerability profile to offer differentiated dosing regimens for the long-term treatment of atopic dermatitis, a chronic relapsing disease requiring long-term management.
