Ironwood takes big stride toward linaclotide NDA

Ironwood Pharmaceuticals ($IRWD) and its partner Forest Laboratories ($FRX) took another big step toward a new drug application for linaclotide with the announcement that the drug had successfully cleared its second late-stage trial hurdle for irritable bowel syndrome with constipation. The developer, a 2009 Fierce 15 company which went public earlier this year, says it is now poised for a regulatory filing in the third quarter of next year.

"By successfully meeting all the primary and secondary endpoints in this trial, we now have two positive Phase III IBS-C trials and two positive Phase III chronic constipation trials," said Howard Solomon, the CEO of Forest Laboratories. "We look forward to filing the NDA for both indications in 2011."

Investigators say Ironwood's lead drug hit key milestones for improving abdominal pain and complete spontaneous bowel movements, proving significantly better than a placebo. "The incidence of adverse events was similar to that observed in the first Phase III trial of linaclotide in patients with IBS-C, with diarrhea being the most common adverse event in linaclotide-treated patients."

From an early point Ironwood CEO Peter Hecht (photo) has vowed to build the biotech company into an integrated company with marketing operations and a significant pipeline of new drugs. And he's built his plans on the clinical success of linaclotide. But Ironwood has found out first hand just how skeptical investors are when it comes to development-stage biotech companies. Ironwood had to significantly cut its asking price in order to complete its February IPO, selling shares at $11.25. And shares have continued to languish. After the news hit yesterday, though, its shares jumped 12 percent to $11.90.

- read the Ironwood release
- and here's the Dow Jones report