Ironwood's Potential Blockbuster Drug Meets Main Goals in Mid-Stage Trial
July 20, 2017
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Ironwood Pharmaceuticals is touting its Phase IIb drug candidate IW-3718 in adult patients with uncontrolled gastroesophageal reflux disease (GERD), but investors seem wary as share prices are down more than 7 percent this morning.
This morning, Ironwood released top-line data from the Phase IIb trial that showed the drug in combination with a proton pump inhibitor (PPI) met the primary endpoint of reducing heartburn severity in patients with uncontrolled GERD compared to patients treated with a PPI alone. IW-3718 is a gastric retentive formulation of a bile acid sequestrant designed to release in the stomach over an extended period of time, bind to bile that refluxes into the stomach, and potentially provide symptomatic relief in uncontrolled GERD, according to company data. The company said the treatment showed patients treated with 1500 mg of IW-3718 and a PPI showed a mean decrease of 58 percent from baseline in heartburn severity. That was compared to 46 percent in patients treated with a PPI alone, the company said.
That seems strong, but industry analysts and apparently investors wanted more. Writing in Endpoints, John Carroll said analyst were looking for “a 15-point or greater separation from the control group—as guided by the company.” During an early morning conference call with Ironwood executives, analysts apparently expressed that concern, Carroll noted.
Carroll also pointed out that on the call this morning some analysts were disappointed with the fact that lower doses of Ironwood’s GERD drug, at 500 mg and 1000 mg, did not meet the endpoints.
Additionally, Ironwood said the GERD treatment showed a mean decrease of 55.4 percent from baseline in regurgitation frequency compared to 37.9 percent in patients treated with a PPI alone.
The company also said the combination of IW-3718 with a PPI showed a clinically meaningful degree of Improvement in weekly heartburn severity. Data touted by the company indicated the combination resulted in a 45 percent reduction in weekly heartburn severity, which was determined to be clinically meaningful for patients in this study based on patient-reported outcome measures.
Still, Ironwood officials are calling the Phase IIb data a success. Mark Currie, Ironwood’s chief scientific officer and president of R&D, said the trial results validate the company’s approach of “targeting bile acid reflux in patients with uncontrolled GERD in addition to suppressing acid with PPIs.”
“These data were consistent and robust across key endpoints, and reinforce our belief that IW-3718 may lead to meaningful symptom relief for patients with uncontrolled GERD,” Currie said in a statement.
PPIs, such as AstraZeneca 's Nexium, are the current standard of care when treating GERD, Ironwood said. Uncontrolled GERD is a chronic condition affecting an estimated 10 million Americans who continue to suffer from symptoms such as heartburn and regurgitation. Treatments like PPIs are used to suppress acid produced in the stomach.
Ironwood said there were no serious side-effects associated with the drug. About 7 percent of patients reported some constipation.
Armed with the Phase IIb data, Ironwood said it plans to conduct an end-of-phase meeting with the U.S. Food and Drug Administration and intends to take the trial into Phase III development in the later part of 2018. If the drug is approved, Ironwood Chief Executive Officer Peter Hecht told Reuters the drug could bring in annual revenue of more than $2 billion.