Incyte's New Treatment for Chronic Skin Disease Shows Promising Results In Latest Clinical Trials, Stock Falls

On Monday, Incyte Corporation INCY released topline results from its pivotal Phase 3 STOP-HS clinical trial program of povorcitinib, an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).

Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic inflammatory skin condition characterized by painful, recurrent boil-like lumps, often in areas where skin rubs together like the armpits and groin, that can lead to abscesses and scarring.

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STOP-HS1 and STOP-HS2 studies met their primary endpoint at both tested doses (45 mg and 75 mg).

A significantly higher proportion of patients treated with povorcitinib once daily versus placebo achieved Hidradenitis Suppurativa Clinical Response (HiSCR), a ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or draining tunnel count.

The percentage of povorcitinib treated patients achieving HiSCR50 compared to placebo at Week 12 was:

• STOP-HS1: 45 mg: 40.2% vs. 29.7% [P=0.024]; 75 mg: 40.6% vs 29.7% [P=0.022].
• STOP-HS2: 45 mg: 42.3% vs. 28.6% [P=0.004]; 75 mg: 42.3% vs. 28.6% [P=0.003].

Within a predefined subgroup of patients previously exposed to biologics, povorcitinib demonstrated greater differential efficacy (HiSCR50) when compared to placebo:

• STOP-HS1: 45 mg: 34.2% vs. 21.9% [P=0.096]; 75 mg: 37.8% vs. 21.9% [P=0.037].
• STOP-HS2: 45 mg: 45.0% vs. 19.5% [P=0.001]; 75 mg: 40.0% vs. 19.5% [P=0.005].

In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30.

Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction.

The overall safety profile of povorcitinib is consistent with previous data. No new safety signals were observed and both doses were well tolerated.

Last week, Incyte revealed results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura) in adult patients with prurigo nodularis, a chronic skin condition characterized by very itchy firm lumps.

Price Action: INCY stock is down 11.90% at $59.78 at the last check Monday.

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