Incyte announced Tuesday that a Phase III study testing a topical cream version of its selective JAK1/JAK2 inhibitor ruxolitinib in adolescents and adults with atopic dermatitis (AD) met its primary endpoint. "This positive top-line result reinforces the potential of ruxolitinib cream, if approved, to offer AD patients a much-needed effective, non-steroidal therapy," remarked Jim Lee, vice president of inflammation and autoimmunity at Incyte.
The TRuE-AD2 study enrolled 618 patients aged 12 years and up who have had a diagnosis of AD for at least two years. Patients with an Investigator's Global Assessment (IGA) score of 2 to 3, and with AD involving between 3% and 20% of their body surface area, excluding the scalp, were randomised to receive one of two doses of ruxolitinib cream administered twice daily, or a non-medicated cream. The primary endpoint is the proportion of patients achieving an IGA Treatment Success (IGA-TS) score of 0 or 1, denoting "clear" or "almost clear" skin, with at least a two-point improvement from baseline after eight weeks. Key secondary goals include at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score and at least a four-point improvement in the itch Numerical Rating Scale (NRS).
Preliminary results indicate that both ruxolitinib treatment groups achieved significance on the primary endpoint, compared with controls. Incyte noted that the overall efficacy and safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed. Participants who successfully completed an assessment at the eight-week mark were eligible to take part in the 44-week long-term safety treatment extension period with ruxolitinib cream.
According to Incyte, ruxolitinib cream is also being evaluated in the ongoing Phase III TRuE-AD1 trial of adolescents and adults with AD, with initial results expected in the first quarter of 2020. In addition, the drug is in late-stage development in the TRuE-V programme for the treatment of adolescents and adults with vitiligo.
Incyte has worldwide rights for the development and commercialisation of ruxolitinib cream. An oral formulation of the drug is already approved to treat myelofibrosis, polycythaemia vera and steroid-refractory acute graft-versus-host disease (GVHD), with Incyte holding marketing rights in the US, where ruxolitinib is sold as Jakafi, and Novartis handling sales outside the US, where the product is known as Jakavi.
Earlier this week, Incyte and partner Eli Lilly reported positive top-line data showing that their JAK inhibitor Olumiant (baricitinib) met the primary EASI75 endpoint of the Phase III BREEZE-AD4 trial in patients with moderate-to-severe AD. Meanwhile, Incyte also recently unveiled results for the JAK1 inhibitor itacitinib in the late-stage GRAVITAS-301 study, saying the experimental drug failed to hit the main goal of overall response rate in patients with treatment-naïve acute GVHD.
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