Ironwood Pharma Passes Third Big Clinical Trial With Constipation Drug, Shares Climb

9/13/10Follow @xconomy

Ironwood Pharmaceuticals went public earlier this year after passing its first two pivotal clinical trials. Now the company has cleared its third major clinical hurdle, which sent the Cambridge, MA-based company’s shares (NASDAQ:IRWD) up by more than 15 percent in after-hours trading.

Ironwood’s experimental drug reached its goal of relieving abdominal pain/discomfort and helping reduce the symptoms of irritable bowel syndrome with constipation, in a study of 803 patients, according to a company statement. Diarrhea was the most commonly reported side effect among patients who got the Ironwood drug, linaclotide, although adverse events were consistent with previous studies, the company said. Now Ironwood has just one more trial left to go to see if it can go 4-for-4 in its ambitious clinical development plan to bring linaclotide to patients around the world.

The results “further support our belief that linaclotide has the potential to improve abdominal pain and bowel symptoms, offering a promising treatment for individuals suffering from this chronic gastrointestinal disorder,” said Ironwood CEO Peter Hecht in a statement.

Ironwood laid the groundwork for its IPO last November, when it said linaclotide had passed its first two clinical trials of 1,270 patients with chronic constipation. This is a tough condition to treat, and Ironwood generated a lot of investor interest because of the big potential market, and the company’s unique strategy to fight the disorder. Linaclotide is a peptide, and while most peptides are injected, Ironwood turned its drug into an oral pill that can withstand stomach acids, work its way into the intestines, and do its job there, without being absorbed into the bloodstream, where it can cause side effects. The drug is thought to be useful for chronic constipation, as well as irritable bowel syndrome with constipation—conditions that are thought to affect millions of people around the world. Ironwood has partnerships with Forest Laboratories (NYSE: FRX) in the U.S., Spain-based Almirall in Europe, and Japan-based Astellas Pharma in Asia.

Peter Hecht

Peter Hecht

Ironwood’s January IPO was priced at $11.25 a share, far below the $14 to $16 range the company was shooting for, which cast a pall over other biotech IPO hopefuls that were hoping to ride a wave of enthusiasm for products still in earlier stages of development. Ironwood’s stock has since slumped a bit, closing today at $9.74 before the announcement of today’s new clinical trial success. But the shares climbed 15 percent, right back to the IPO price of $11.25 at 5:30 pm Eastern time after today’s announcement.

Most of the details on the study, known as LIN-MD-31, will come out later at a scientific meeting. But there were some details provided by Ironwood and Almirall today in a statement. Researchers found that 55 percent of patients who got a once-daily dose of linaclotide reported a 30 percent decrease in abdominal pain or the abdominal discomfort score during the study, while just 42 percent did that well on a placebo. About 37 percent of patients on the new drug told doctors that they felt “considerably relieved” or “completely relieved” for at least half of the 12-week study, while only 18 percent said the same thing when they were on placebo. The new drug was shown to have a statistically significant advantage over placebo on all the main secondary endpoints measured in the study (stool frequency, stool consistency, straining and bloating) researchers said.

Ironwood still has one more trial left to pass on its agenda. That fourth pivotal study is expected to produce results before the end of the year. If that fourth trial matches up with the findings from the first three, Ironwood and its partners will be in position to put together their new drug application to regulators around the world. And investors will surely start sharpening up their financial models, attempting to predict when this drug will hit the market, and how quickly it will gain commercial acceptance from doctors and patients.

Ironwood is holding a conference call to discuss the results with investors at 6 pm Eastern/3 pm Pacific. To listen to the webcast, click here.

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