Incyte (INCY) Posts Upbeat Data From Phase II Vitiligo Study
Incyte INCY announced new positive 52-week data from its mid-stage study of povorcitinib, evaluating the candidate’s safety and efficacy in the treatment of adult patients with extensive nonsegmental vitiligo.
Povorcitinib (formerly INCB54707) is Incyte’s investigational oral small-molecule JAK1 inhibitor.
The phase IIb dose-ranging study is evaluating the efficacy and safety of povorcitinib in adult patients with extensive nonsegmental vitiligo.
Data from the phase IIb study showed that the treatment with oral povorcitinib caused substantial total body and facial repigmentation across all treatment groups at week 52.
Management claims that the 52-week study results reaffirm the previously reported positive top-line data from the phase II study and bolster the efficacy profile and potential of povorcitinib as an oral treatment for patients with extensive nonsegmental vitiligo.
Year to date, shares of Incyte have plunged 29.1% compared with the industry’s decline of 18.8%.
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The study enrolled 171 patients (aged 18 to 75 years) diagnosed with nonsegmental vitiligo affecting ≥8% of their body surface area. The patients were randomized equally to receive either a once-daily dose of povorcitinib (15 mg, 45 mg or 75 mg) or placebo for 24 weeks. Among these, 168 patients were treated as part of the 24-week placebo-controlled period.
The study had previously met its primary endpoint of percentage change from baseline in the total body Vitiligo Area Scoring Index (T-VASI) at week 24. The key secondary endpoint of the percentage of patients achieving T-VASI50 (≥50% reduction from baseline in the T-VASI) at week 24, was also achieved.
Per the 52-week data readout, treatment with all doses of povorcitinib observed significant improvement in mean percentage total body depigmentation improvement from baseline as measured by T-VASI. Significant improvement in mean percentage facial depigmentation improvement from baseline as measured by the facial Vitiligo Area Scoring Index was also observed at week 52 for all dose ranges of povorcitinib.
Encouraging key secondary findings were also observed at the end of week 52 in patients receiving the four doses of povorcitinib.
Incyte also reported that all dose strengths of the candidate were overall well tolerated and treatment-related adverse events were mostly mild-moderate in severity.
Among the total enrolled patients, 32 patients who completed the follow-up period of the phase II study through week 76, observed the maintenance of total body and facial repigmentation. This signifies povorcitinib’s durability of response following treatment discontinuation.
Vitiligo is a chronic autoimmune disease characterized by the depigmentation of the skin that results from the loss of pigment-producing cells known as melanocytes.
Apart from vitiligo, Incyte is currently studying povorcitinib in other indications including, hidradenitis suppurativa (HS) and prurigo nodularis. Phase III studies evaluating povorcitinib in HS are currently ongoing.
Incyte Corporation Price and Consensus
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Zacks Rank and Stocks to Consider
Incyte currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector areDynavax Technologies DVAX, Corcept Therapeutics CORT and Annovis Bio ANVS. Currently, DVAX sports a Zacks Rank #1 (Strong Buy), while CORT and ANVS carry a Zacks Rank #2 (Buy) each.
You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have gained 36.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. During the same period, the estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have gained 35.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2023 loss per share has remained constant at $4.38. During the same period, the estimate for Annovis’ 2024 loss per share has also remained constant at $2.77. Year to date, shares of ANVS have lost 42.7%.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 13.40%.
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