Ironwood Initiates Phase III Studies On Reflux Candidate

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced the initiation of two phase III studies to evaluate its gastrointestinal candidate, IW-3718, for the treatment of persistent gastroesophageal reflux disease (“GERD”).

The phase III studies will evaluate a 1500 mg dose of IW-3718 twice daily for eight weeks in patients with GERD receiving proton pump inhibitors (PPIs) – the current standard of care – compared to placebo for reduction in heartburn. The primary endpoint of the study is a minimum 45% reduction in heartburn severity in GERD patients from baseline for at least four out of eight weeks, including at least one of the last two weeks.

A look at its share price movement shows that the stock has outperformed the industry this year so far. Ironwood’s shares have gained 24.2%, while the industry registered an increase of 5.5%.

We remind investors that the company had announced positive results in July 2017 from a phase IIb study evaluating IW-3718. Data showed that the addition of IW-3718 to PPI reduced heartburn severity by 58% from baseline against a 46% for PPI alone. Moreover, 52.9% of the patients treated with IW-3718 on top of PPI achieved a 45% reduction in heartburn severity from baseline for at least four out of eight weeks, including at least one of the last two weeks. This was achieved in 37.1% patients treated with PPI alone. However, we note that the results were below expectation.

IW-3718 also reduced the frequency of regurgitation – acid rising into the throat and burning the esophagus – by 55.4% from baseline versus 37.9% reduction achieved by PPI alone.

Per the press release, the number of adults with GERD is estimated to be 10 million in the United States 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 which include AstraZeneca PLC’s (NYSE:AZN) Nexium and Procter & Gamble’s (NYSE:PG) over-the-counter drug, Prilosec.

Ironwood Pharmaceuticals, Inc. Price

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Zacks Rank & Stocks to Consider

Ironwood currently carries a Zacks Rank #3 (Hold).

Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE) is a better-ranked stock in the pharma sector carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aeglea’s loss estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the last 60 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. Its share price has increased 93.7% so far this year.

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