AbbVie/Boehringer Report Crohn's Disease Drug Interim Data

AbbVie Inc. (NYSE:ABBV) and Boehringer Ingelheim announced that interim results were presented from a randomized, placebo-controlled, proof-of-concept phase II study evaluating intravenous risankizumab (IL-23 inhibitor; 200 mg and 600 mg) versus placebo administered at weeks zero, four, and eight in patients with moderately to severely active Crohn's disease. Data were presented at the Digestive Disease Week.

Results showed that 24% and 37% of patients achieved clinical remission with 200 mg and 600 mg risankizumab, respectively, compared with the placebo arm (15%) after 12 weeks. Additionally, endoscopic remission was achieved by 15% and 20% of patients who received 200 mg and 600 mg risankizumab, respectively, compared with 3% of patients who received placebo. Moreover, almost twice as many patients achieved a clinical response with risankizumab (37% and 42% in the 200 mg and 600 mg groups, respectively), compared with the placebo group (21%) at week 12.

On the safety front, risankizumab was found to be well tolerated in the study with numerically fewer severe or serious adverse events being reported in patients when treated with risankizumab compared to placebo.

Considering that patients with moderate-to-severe Crohn's disease who have failed anti-TNF therapy have inadequate choices for treatment, the interim data are encouraging. The study is currently in progress and will evaluate patients up to 52 weeks.

In Mar 2016, AbbVie and Boehringer had announced a collaboration agreement under which the former is responsible for the development and commercialization of risankizumab globally. Apart from Crohn’s disease, risankizumab is also being evaluated for a couple of other immunological disorders including psoriasis and psoriatic arthritis.

Upon successful development and subsequent approval, risankizumab will enter a high potential but immensely crowded market given the presence of drugs like Stelara, Cosentyx and Enbrel among others.

AbbVie is currently a Zacks Rank #5 (Strong Sell) stock. Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (NYSE:BMY) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Retrophin, Inc. (NASDAQ:RTRX) , each sporting a Zacks Rank #1 (Strong Buy).