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AbbVie Psoriasis Candidate Succeeds in 4th Phase III Study


AbbVie, Inc. ABBV announced that a fourth pivotal phase III study evaluating its investigational IL-23 inhibitor, risankizumab for the treatment of moderate-to-severe chronic plaque psoriasis, met all co-primary and secondary endpoints.

Top line data from the IMMhance study showed that a significant portion of patients treated with risankizumab achieved high levels of skin clearance. Nearly half (47%) of the patients treated with risankizumab achieved complete skin clearance versus placebo (1%) after 16 weeks of treatment.

On continuous treatment with risankizumab, at week 28, 87% of the risankizumab patients maintained this response for one year. This data shows that patients can achieve better disease improvement over time on continuous treatment with risankizumab rather than withdrawing from the therapy after an initial response. Results from this study will support regulatory filings for the candidate.

The 16-week results from this study were presented at the 8th International Congress of Psoriasis from Gene to Clinic meeting in London.

AbbVie had in-licensed risankizumab from Boehringer Ingelheim in 2016. AbbVie is responsible for the future development and commercialization of the candidate.

We remind investors that in October, AbbVie had announced that three pivotal head-to-head phase III studies evaluating risankizumab versus Johnson & Johnson’s JNJ Stelara and AbbVie’s Humira, for the treatment of moderate-to-severe chronic plaque psoriasis, met all co-primary and secondary endpoints. Top-line data presented from the studies showed that risankizumab achieved significantly greater response of clear or almost clear skin versus Stelara and Humira or placebo after 16 weeks of treatment.

Risankizumab is also being evaluated in phase II studies for other immunological disorders like Crohn’s disease and psoriatic arthritis.

AbbVie’s shares have gained 52% so far this year, comparing favorably with a gain of only 16.5 % recorded by the industry.

The share price surge was supported by a series of positive news in the past few months. AbbVie presented promising data from several pivotal studies, gained regulatory approvals in the United States, Europe, and Japan for its competitive HCV medicine, Mavyret, received FDA approval for the sixth indication for Imbrivicaand settled its Humira patent disputes with Amgen, Inc. AMGN.

AbbVie carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked large-cap pharma stock is H. Lundbeck A/S HLUYY, carrying a Zacks Rank #2 (Buy).

Shares of Lundbeck have risen 21.7% so far this year while 2018 earnings estimates have gone up 3.2% in the past 30 days.

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