Fly News Breaks for January 3, 2020
Jan 3, 2020 | 08:15 EDT
Stifel analyst Stephen Willey said he doesn't view the itacitinib failure in the Phase 3 GRAVITAS-301 trial as causing a material change to thesis on Incyte, but he does understand the "investor negativity" given the perceived negative read-through into the odds of success for the ongoing Phase 3 GRAVITAS-309 trial evaluating itacitinib in the steroid-refractory, chronic graft-versus-host disease setting. He is "inclined to believe" the post-close loss in market cap seems a bit overdone, though Willey keeps a Hold rating on Incyte.
News For INCY From the Last 2 Days
Feb 19, 2020 | 10:50 EST
Piper Sandler analyst Tyler Van Buren noted that TRuE-AD1 was the second of Incyte's two pivotal atopic dermatitis, or AD, trials to succeed and he called the data reported his morning for ruxolitinib cream "impressive." He believes the placebo-adjusted benefits between 31-44% exceed management and investor expectations and also notes those type of results are twice to three times what is observed with Eucrisa. Based on the two trials, topical ruxolitinib is "highly likely to be approved" and "has the profile of an exciting $500MM+ topical AD product," contends Van Buren, who reiterated his Overweight rating on Incyte shares.
Feb 19, 2020 | 07:43 EST
Incyte announced that the second randomized, vehicle-controlled, pivotal Phase 3 study from the TRuE-AD clinical trial program has met its primary endpoint. Building on the previously-reported topline results from TRuE-AD2, the results of TRuE-AD1 also show that significantly more patients treated with ruxolitinib cream 0.75% or 1.5% achieved Investigator's Global Assessment Treatment Success. The overall efficacy and safety profile of ruxolitinib cream was consistent with previous data, and no new safety signals were observed. The TRuE-AD1 and TRuE-AD2 trials both evaluated the safety and efficacy of ruxolitinib cream in adolescent and adult patients with mild-to-moderate atopic dermatitis, or AD. The long-term safety portion of both studies will continue as planned. Additionally, data from both studies will be further analyzed and submitted for publication and presentation at an upcoming scientific meeting. Almost 1,250 patients diagnosed with AD for at least two years and who are candidates for topical therapy were enrolled in the identically-designed TRuE-AD1 and TRuE-AD2 trials. Patients with an Investigator's Global Assessment, or IGA, score of 2 to 3, and with AD on 3% to 20% of their body surface area were randomized 2:2:1 into one of three treatment arms for eight weeks, including: ruxolitinib cream 0.75% administered twice daily; ruxolitinib cream 1.5% BID and vehicle. The primary endpoint of both TRuE-AD1 and TRuE-AD2 was IGA-TS at week 8. Secondary endpoints in both trials included the proportion of participants who achieved a 75% improvement in Eczema Area and Severity Index score at week 8 and the proportion of participants with a 4-point improvement in Itch Numerical Rating Scale score at week 8. In TRuE-AD1, 50% of patients treated with ruxolitinib cream 0.75% BID and 53.8% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 15.1% treated with vehicle control. Also 56% of patients treated with ruxolitinib cream 0.75% BID and 62.1% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 24.6% treated with vehicle control. In TRuE-AD2, 39% of patients treated with ruxolitinib cream 0.75% BID and 51.3% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 7.6% treated with vehicle control. Also 51.5% of patients treated with ruxolitinib cream 0.75% BID and 61.8% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 14.4% treated with vehicle control. In addition, a statistically-significant difference in itch reduction as measured by the NRS4 was observed for both dose strengths compared to vehicle control in both TRuE-AD1 and TRuE-AD2. In both TRuE-AD1 and TRuE-AD2 after eight weeks of treatment, the overall rate of treatment emergent adverse events was comparable between the ruxolitinib cream 0.75% BID, ruxolitinib cream 1.5% BID and vehicle control groups. The rate of serious adverse events was 0.8% and 0.6% for ruxolitinib cream 0.75% BID and 1.5% BID, respectively, and 0.8% for vehicle control. Long-term safety is currently being evaluated in the 44-week extension period of both studies.