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Anthera's Sollpura Strong on Positive Futility in Phase III

Zacks Equity Research

Anthera Pharmaceuticals, Inc. ANTH shares increased almost 11% on Jan 22 after the company announced encouraging results from the second interim futility analysis of a phase III study —– RESULT — on one of its pipeline candidates, Sollpura (liprotamase), in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI).

The company said that it is on track to release top-line data from the study later in the first quarter of 2018.

Anthera’s share price movement shows that the stock has underperformed the industry in a year’s time. While the stock has tumbled 68.1% during the period, the industry has increased 8.6%.

 

Notably, the RESULT study was initiated in the second quarter of 2017 as an additional trial on EPI patients after the company missed primary endpoints in another phase III SOLUTION program in December 2016.

We remind investors that the SOLUTION study was initiated in October 2015, which barely missed the primary endpoint of a change in the Coefficient of Fat Absorption non-inferiority margin. However, Sollpura achieved the statistical criterion for nitrogen absorption. On the safety front, the candidate was found to be well-tolerated in comparison to Pancreaze, though symptoms associated with malabsorption were modestly more recurrent in the Sollpura arm.

Considering the robust activity demonstrated by Sollpura in the study, the company believed that the deficiency in fat absorption was probably addressed by small changes in the study design including more liberal dose adjustment. Therefore, Anthera subsequently commenced the RESULT analysis.

During the third quarter of 2016, the EASY study was, initiated providing a continued access to Sollpura for patients in the Sollpura arm, who completed the SOLUTION study. The company plan to modify this trial to allow certain patients completing the RESULT study to have continued access until the Biological License Application for Sollpura is approved by the FDA.

Note that Anthera is now conducting another phase III study — SIMPLICITY — on pediatric patients with the aforementioned indication.

Anthera Pharmaceuticals, Inc. Price

Anthera Pharmaceuticals, Inc. Price | Anthera Pharmaceuticals, Inc. Quote

 

Zacks Rank & Other Key Picks

Anthera carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the health care sector are Exelixis, Inc. EXEL, XOMA Corporation XOMA and Sucampo Pharmaceuticals, Inc. SCMP. While Exelixis and XOMA sport a Zacks Rank #1 (Strong Buy), Sucampo carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis’ earnings per share estimates have been revised upward from 72 cents to 73 cents for 2018 over the last 60 days. The company pulled off a positive earnings surprise in each of the trailing four quarters with an average beat of 572.92%. Share price of the company has soared 61.3% in a year’s time.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 over the last 60 days. The company came up with an average beat of 47.92%. The stock has skyrocketed 663.1% in the last 12 months.

Sucampo’s earnings per share estimates have moved north from $1.15 to $1.19 for 2018 in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. The company’s share price has surged 59.8% in a year.

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