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Ironwood (IRWD) Reports Positive Data on Reflux Candidate

Ironwood Pharmaceuticals, Inc. IRWD announced positive top-line data from a phase IIb study evaluating its gastrointestinal (GI) candidate, IW-3718, for the treatment of uncontrolled gastroesophageal reflux disease (GERD) in adult patients.

The study met its primary endpoint. The results demonstrated that an oral dose of IW-3718 (1500 mg) administered twice daily in combination with a proton pump inhibitor (PPI) significantly reduced heartburn severity (HS) in patients when compared to PPI alone.

However, investors didn’t seem to be impressed with the outcome. The clinical benefit shown by IW-3718 versus PPI alone was below expectations, which probably pulled the stock down by more than 8% on Thursday.

A look at its share price movement shows that the stock has outperformed the industry this year so far. Ironwood’s shares gained 11.1% during this period, while the industry registered an increase of 7.5%.

Coming back to the news, the data from the study showed that the addition of IW-3718 to PPI decreased HS by 58% from baseline against a 46% reduction with PPI alone. The company said that the candidate’s performance was also better than 45% reduction in HS, which is considered to be a clinically meaningful improvement. The data also demonstrated that 52.9% of the patients were heartburn responders versus 37.1% for PPI alone. Heart responders were those patients who achieved a 45% reduction in HS from baseline for at least four out of eight weeks, including at least one of the last two weeks.

IW-3718 also decreased the frequency of regurgitation, when acid rises into the throat and burns the esophagus, by 55.4% from baseline versus 37.9% reduction achieved by PPI alone.

The company plans to present additional data from the study at an upcoming scientific meeting and in peer-reviewed journals. Also, it plans to have the end-of-phase II meetings with the FDA and initiate a phase III study in the second half of 2018.

Per the press release, the number of adults with GERD is estimated to be 10 million in the U.S. and more than 60 million globally. A person associated with the study said that GERD patients are seeking new treatment options as they continue to suffer despite receiving treatment with PPIs – the current standard of care – which includes AstraZeneca PLC’s AZN Nexium and Prilosec.

Zacks Rank and Key Picks

Ironwood Pharma currently carries a Zacks Rank #2 (Buy).

Some top-ranked stocks in the health care sector include Enzo Biochem, Inc. ENZ and Ionis Pharmaceuticals, Inc. IONS. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Enzo Biochem’s loss estimates have narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018 over the last 60 days. The company came up with positive earnings surprise in the last four quarters, with an average beat of 55.83%. Its share price is up 65.3% so far this year.

Ionis Pharma’s loss estimates narrowed from 47 cents to 27 cents for 2017 and from 28 cents to 12 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in three of the last four quarters, with an average beat of 95.7%. The stock is up 16.8% so far this year.

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Astrazeneca PLC (AZN): Free Stock Analysis Report
 
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