Yahoo Finance Incyte (INCY) Reports Positive Long-Term Data From HS Study
Incyte INCY announced new data from a mid-stage study (open-label extension period) evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS).
HS is a chronic and debilitating inflammatory skin condition characterized by painful nodules and abscesses that can lead to irreversible tissue destruction and scarring.
These data were presented at the 12th Conference of the European Hidradenitis Suppurativa Foundation in Florence, Italy.
This phase II, randomized, double-blind, placebo-controlled, dose-ranging study is evaluating the efficacy and safety of povorcitinib (formerly INCB54707) in adult patients with HS.
The first part of the study spanned 16 weeks and enrolled 209 adults (aged 18-75 years) who were randomized 1:1:1:1 to povorcitinib 15 mg once daily (QD; n=52), 45 mg QD (n=52), 75 mg QD (n=53) or placebo (n=52). The primary efficacy endpoint is the mean change from baseline in Abscess and Inflammatory Nodule (AN) count at week 16. The key secondary endpoint is the percentage of patients achieving HS Clinical Response at week 16. The study previously met its primary endpoint.
The second part of the study, the open-label extension (OLE) period, spanned an additional 36 weeks (52 weeks total) and included patients enrolled in the first part of the study. All OLE patient participants (n=174) received treatment with povorcitinib 75 mg QD. Patients who completed baseline, week 16 and week 52 assessments could continue to receive open-label treatment with povorcitinib 75 mg QD for an additional 48 weeks after week 52.
Results from the open-label extension period of the study demonstrated that longer-term treatment with povorcitinib 75 mg resulted in sustained and durable efficacy across all treatment arms. Povorcitinib also demonstrated durable efficacy at week 52 in high-threshold outcomes, as evidenced by 22-29% of patients achieving HS Clinical Response 100.
A phase III study in patients with moderate-to-severe HS is ongoing.
Povorcitinib is also being evaluated for vitiligo and prurigo nodularis.
Shares of Incyte have gained 20% in the past year against the industry’s decline of 8.6%.
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Incyte recently reported better-than-expected results for the fourth quarter, driven by growth in patient demand for the lead drug, Jakafi, higher royalty revenues and encouraging uptake of other recently approved drugs.
The successful development of other drugs will add an incremental stream of revenues to the top line and reduce the company’s dependence on Jakafi.
Incyte has a collaboration agreement with Swiss pharma giant Novartis NVS for Jakafi.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Incyte currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Alkermes ALKS and Dynavax Technologies DVAX, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, earnings estimates for Alkermes for 2022 have increased by 2 cents to 25 cents. Alkermes surpassed estimates in three of the trailing four quarters and met the same in the remaining one, the average surprise being 306.73%.
Over the past 60 days, earnings estimates for Dynavax for 2022 have increased by 11 cents to $1.95. Dynavax surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 73.15%.
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