AbbVie (ABBV – Free Report) announced positive top-line data from two phase III studies evaluating its psoriasis drug, Skyrizi (risankizumab) for another indication — moderate-to-severe Crohn’s disease. Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis.
Data from two phase III induction studies — ADVANCE and MOTIVATE — evaluating two doses of Skyrizi (600mg & 12mg) showed that significantly more patients treated with risankizumab achieved clinical remission and endoscopic response, co-primary endpoints of both studies, at week 12 versus placebo. Detailed data from the study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.
AbbVie is currently evaluating risankizumab in a maintenance study for Crohn’s disease. Following the completion of the maintenance study, the company will submit the study data along with data from ADVANCE and MOTIVATE studies to regulatory authorities for a potential label expansion of the drug in Crohn’s disease.
The ADVANCE study included mixed adult patients who had an inadequate response or were intolerant to either to a conventional therapy or a biologic therapy or both. The MOTIVATE study included adult patients who had responded inadequately or were intolerant to biologic therapy only.
In both studies, the primary endpoint of clinical remission was measured by clinical remission was measured by CDAI (Crohn’s Disease Activity Index) and PRO-2 (two-component patient-reported outcome). Endoscopic response was measured as a greater than 50% decrease from baseline in simple endoscopic score for Crohn’s disease (SES-CD).
In ADVANCE study, 45% and 43% of patients achieved clinical remission per CDAI and PRO-2, respectively, for the 600mg dose. Clinical remission was achieved in 42% and 41% of patients receiving 1200mg dose per CDAI and PRO-2, respectively. Clinical remission per CDAI and PRO-2 were 25% and 21%, respectively, in the placebo arm. Endoscopic response was achieved in 40% and 32% of patients for the 600mg and 1200mg doses, respectively, versus 12% for placebo.
In MOTIVATE study, 42% and 35% of patients achieved clinical remission per CDAI and PRO-2, respectively, for the 600mg dose. Clinical remission was achieved in 35% and 39% of patients receiving 1200mg dose per CDAI and PRO-2, respectively. Clinical remission per both CDAI and PRO-2 were 19% in the placebo arm. Endoscopic response was achieved in 29% and 34% of patients for the 600mg and 1200mg doses, respectively, versus 11% for placebo.
The company is also developing the drug in late-stage studies for psoriasis and psoriatic arthritis, and a phase II study is evaluating it in ulcerative colitis. Earlier this week, positive data was announced from psoriatic arthritis studies.
AbbVie’s stock has risen 18.3% in the past year compared with an increase of 3.6% for the industry.
Skyrizi, along with another important new immunology drug, Rinvoq, demonstrated differentiated clinical profiles versus Humira and are expected to lower AbbVie’s dependence on Humira. Humira generated almost 46% of total sales in the first nine months of 2020. With many new indications coming in the next couple of years, sales of Skyrizi and Rinvoq could be higher and have the potential to replace Humira when generics are launched in 2023.
Per settlements with nine manufacturers like Biogen (BIIB – Free Report) /Samsung Bioepis, Amgen (AMGN – Free Report) , Sandoz (generic arm of Novartis [(NVS – Free Report) ]), among others, Humira biosimilars are expected to be launched in the United States in 2023. In the international markets, AbbVie is already facing direct biosimilar competition in Europe and other countries.
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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